acronym: Phase 3 trial of first line etoposide/platinum with or without pembrolizumab in ES-SCLC(KEYNOTE-604)

title: A Phase 3 Randomized, Double-Blind, Placebo-controlled Trial of Pembrolizumab (MK-3475/SCH900475) in Combination With Etoposide/Platinum (Cisplatin or Carboplatin) for the First-line Treatment of Subjects With Extensive Stage Small Cell Lung Cancer (KEYNOTE-604)

lead_sponsor: Merck Sharp & Dohme LLC

ReferenceType: result

ReferenceCitation: Rudin CM, Awad MM, Navarro A, Gottfried M, Peters S, Csőszi T, Cheema PK, Rodriguez-Abreu D, Wollner M, Yang JC, Mazieres J, Orlandi FJ, Luft A, Gümüş M, Kato T, Kalemkerian GP, Luo Y, Ebiana V, Pietanza MC, Kim HR; KEYNOTE-604 Investigators. Pembrolizumab or Placebo Plus Etoposide and Platinum as First-Line Therapy for Extensive-Stage Small-Cell Lung Cancer: Randomized, Double-Blind, Phase III KEYNOTE-604 Study. J Clin Oncol. 2020 Jul 20;38(21):2369-2379. doi: 10.1200/JCO.20.00793. Epub 2020 May 29.

location_country:
Poland
Taiwan
Spain
Ireland
Russian Federation
Australia
New Zealand
Canada
United Kingdom
Switzerland
Hungary
Korea, Republic of
United States
Chile
France
Israel
Turkey
Japan
Germany

location_facility: Massachusetts General Hospital ( Site 1203)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1229)

location_facility: Memorial Sloan Kettering Cancer Center - Rockville Centre ( Site 1228)

location_facility: Zala Megyei Szent Rafael Korhaz ( Site 0457)

location_facility: Bon Secours St. Francis Health Sytem ( Site 1212)

location_facility: Orszagos Onkologiai Intezet ( Site 0453)

location_facility: The Cancer Institute Hospital of JFCR ( Site 0606)

location_facility: Southern Medical Day Care Centre ( Site 0001)

location_facility: Kocaeli Universitesi Tip Fakultesi ( Site 1061)

location_facility: CIUSSS Ouest de l'Ile - St-Mary's Hospital ( Site 0158)

location_facility: National Hospital Organization Yamaguchi Ube Medical Center ( Site 0601)

location_facility: CISSS-CA Hotel Dieu de Levis ( Site 0154)

location_facility: Duke University Medical Center ( Site 1214)

location_facility: Ege Universitesi Tıp Fakultesi ( Site 1052)

location_facility: Niigata Cancer Center Hospital ( Site 0610)

location_facility: Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie ( Site 0751)

location_facility: Birmingham Heartlands Hospital ( Site 1162)

location_facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 0607)

location_facility: Taichung Veterans General Hospital ( Site 1007)

location_facility: Complejo Hospitalario Universitario de A Coruna ( Site 0953)

location_facility: Mazowiecki Szpital Onkologiczny ( Site 0757)

location_facility: CHU Nantes - Hopital Laennec ( Site 0363)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0452)

location_facility: Comprehensive Cancer Centers of Nevada ( Site 8004)

location_facility: Medizinische Fakultaet Carl Gustav Carus der TU Dresden ( Site 0411)

location_facility: Wakayama Medical University Hospital ( Site 0612)

location_facility: St Vincents Hospital Melbourne ( Site 0005)

location_facility: Universitaetsklinikum Tuebingen ( Site 0404)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0458)

location_facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0451)

location_facility: Ramban Medical Center - Dept. Hemato. & B. Marrow Transplant ( Site 0502)

location_facility: Inje University Haeundae Paik Hospital ( Site 0905)

location_facility: Evangelische Lungenklinik Berlin ( Site 0403)

location_facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1060)

location_facility: Instituto Nacional del Cancer ( Site 0207)

location_facility: Inonu Universitesi Tip Fakultesi ( Site 1059)

location_facility: Dana-Farber Cancer Institute [Boston] ( Site 1201)

location_facility: Hiroshima University Hospital ( Site 0604)

location_facility: Hospital Universitario Fundacion Jimenez Diaz ( Site 0954)

location_facility: Beth Israel Deaconess Medical Center ( Site 1206)

location_facility: Chi Mei Medical Center Liuying ( Site 1006)

location_facility: St. Jerome Medical Research Inc. ( Site 0160)

location_facility: Belgorod Regional Oncology Dispensary ( Site 0804)

location_facility: Petz Aladar Megyei Oktato Korhaz ( Site 0460)

location_facility: North Shore University Health System ( Site 1216)

location_facility: Dolnoslaskie Centrum Onkologii we Wroclawiu ( Site 0771)

location_facility: Nova Scotia Health Authority ( Site 0157)

location_facility: St Vincents University Hospital ( Site 1456)

location_facility: Thoraxklinik Heidelberg gGmbH am Universitaetsklinikum Heidelberg ( Site 0401)

location_facility: Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F. ( Site 1005)

location_facility: Institut de Cancerologie Jean-Godinot ( Site 0351)

location_facility: National Hospital Organization Kyushu Medical Center ( Site 0617)

location_facility: Baskent University Adana Dr. Turgut Noyan EAH ( Site 1057)

location_facility: National Cancer Center Hospital East ( Site 0613)

location_facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 1227)

location_facility: St James s University Hospital ( Site 1161)

location_facility: Taipei Veterans General Hospital ( Site 1002)

location_facility: Baptist Health Medical Group Oncology, LLC ( Site 8000)

location_facility: Medeniyet Uni. Goztepe Egitim ve Arast. Hast. ( Site 1064)

location_facility: Florence Nightingale Krankenhaus ( Site 0413)

location_facility: Philipps-Universitat Marburg ( Site 0414)

location_facility: Tennessee Oncology, PLLC/The Sarah Cannon Research Institute ( Site 1230)

location_facility: Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz ( Site 0456)

location_facility: National Taiwan University Hospital ( Site 1001)

location_facility: Fundacion Arturo Lopez Perez FALP ( Site 0203)

location_facility: Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu ( Site 0756)

location_facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 1225)

location_facility: Sunnybrook Research Institute ( Site 0151)

location_facility: National Cheng Kung University Hospital ( Site 1004)

location_facility: Hospital Universitario Insular de Gran Canaria ( Site 0952)

location_facility: National Hospital Organization Nagoya Medical Center ( Site 0615)

location_facility: SBI of Stavropol region Pyatigorskiy Oncologic dispensary ( Site 0811)

location_facility: Minnesota Oncology Hematology, PA ( Site 8001)

location_facility: CISSS de la Monteregie-Centre ( Site 0152)

location_facility: CHRU de Lille - Hopital Albert Calmette ( Site 0353)

location_facility: Clinica Universidad Catolica del Maule ( Site 0208)

location_facility: Universitaetsspital Zuerich ( Site 1404)

location_facility: China Medical University Hospital. ( Site 1003)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1211)

location_facility: Chaim Sheba Medical Center. ( Site 0501)

location_facility: Pontificia Universidad Catolica de Chile ( Site 0206)

location_facility: Hospital General Universitario Gregorio Maranon ( Site 0958)

location_facility: Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 1226)

location_facility: Osaka International Cancer Institute ( Site 0616)

location_facility: National Hospital Organization Shikoku Cancer Center ( Site 0614)

location_facility: Veszprem Megyei Tudogyogyintezet ( Site 0454)

location_facility: SBHI Leningrad Regional Clinical Hospital ( Site 0803)

location_facility: CHU de Toulouse - Hopital Larrey ( Site 0354)

location_facility: Severance Hospital Yonsei University Health System ( Site 0903)

location_facility: William Osler Health System (Brampton Civic Hospital) ( Site 0161)

location_facility: SKPP UM im. Karola Marcinkowkiego w Poznaniu ( Site 0766)

location_facility: Hospital Universitari Vall d Hebron ( Site 0951)

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 0762)

location_facility: Montefiore Einstein Center for Cancer Care - Main site ( Site 1204)

location_facility: Weinberg Cancer Institute at Franklin Square ( Site 1210)

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawla II ( Site 0768)

location_facility: Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli ( Site 0767)

location_facility: Hospital Clinico Universitario de Valencia ( Site 0955)

location_facility: National Hospital Organization Kinki-chuo Chest Medical Center ( Site 0608)

location_facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1058)

location_facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center ( Site 8003)

location_facility: Kingston Health Sciences Centre ( Site 0155)

location_facility: Municipal Clinical Oncology Center ( Site 0802)

location_facility: Medical Park Izmir Hospital ( Site 1051)

location_facility: Canterbury Regional Cancer & Blood Services ( Site 0701)

location_facility: Rush University Medical Center ( Site 1215)

location_facility: Orszagos Koranyi TBC es Pulmonologiai Intezet ( Site 0459)

location_facility: Dr. Abdurrahman Yurtaslan Ankara Onkoloji EAH ( Site 1053)

location_facility: CHUV Centre Hospitalier Universitaire Vaudois ( Site 1405)

summary:
The purpose of this study is to assess the safety and efficacy of pembrolizumab plus standard of care (SOC) chemotherapy (etoposide/platinum [EP]) in participants with newly diagnosed extensive stage small cell lung cancer (ES-SCLC) who have not previously received systemic therapy for this malignancy.

The primary study hypotheses are that pembrolizumab+EP prolongs Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by blinded independent central review (BICR) and Overall Survival (OS) compared with placebo+EP in adult participants with ES-SCLC. In this study, RECIST 1.1 has been modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ.

With protocol Amendment 07 (03-Oct-2018), the outcome measure of "Change from Baseline at Weeks 12 and 24 in European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) Global Health Status/Quality of Life Scale" was replaced with a single time point analysis at Week 18.


status: Recruiting

primary_purpose: Treatment

intervention_type: Biological

title: A Phase 3, Open-label, Randomized Study of Nivolumab Combined With Ipilimumab, or With Standard of Care Chemotherapy, Versus Standard of Care Chemotherapy in Participants With Previously Untreated Unresectable or Metastatic Urothelial Cancer

study_completion_date_type: Anticipated

lead_sponsor: Bristol-Myers Squibb

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

enrollment_type: Anticipated

location_country:
Spain
Italy
United States
Peru
Romania
Japan
Czechia
Poland
Russian Federation
Australia
Argentina
Israel
Turkey
Mexico
Norway
Singapore
Sweden
Brazil
Canada
Switzerland
Hungary
China
Germany
Denmark
Taiwan
Greece
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility: Alaska Urological Institute dba Alaska Clinical Research Center

summary: The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.

lead_sponsor_type: industriel

status_simplified: Ongoing


title: A Multicenter, Randomized, Double-blind, Parallel-group, Clinical Study of S-649266 Compared With Meropenem for the Treatment of Hospital-acquired Bacterial Pneumonia, Ventilator-associated Bacterial Pneumonia, or Healthcare-associated Bacterial Pneumonia Caused by Gram-negative Pathogens

acronym: APEKS-NP

summary: The primary objective of this study is to compare all-cause mortality at Day 14 in participants receiving cefiderocol with participants receiving the comparator, meropenem, in adults with hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), or healthcare-associated bacterial pneumonia (HCABP) caused by Gram-negative pathogens.

status: Completed

study_completion_date_type: Actual

enrollment_type: Actual

ReferenceType: derived

ReferenceCitation: Nordmann P, Shields RK, Doi Y, Takemura M, Echols R, Matsunaga Y, Yamano Y. Mechanisms of Reduced Susceptibility to Cefiderocol Among Isolates from the CREDIBLE-CR and APEKS-NP Clinical Trials. Microb Drug Resist. 2022 Apr;28(4):398-407. doi: 10.1089/mdr.2021.0180. Epub 2022 Jan 24.

ReferenceCitation: Skaar EP, Echols R, Matsunaga Y, Menon A, Portsmouth S. Iron serum levels and iron homeostasis parameters in patients with nosocomial pneumonia treated with cefiderocol: post hoc analysis of the APEKS-NP study. Eur J Clin Microbiol Infect Dis. 2022 Mar;41(3):467-476. doi: 10.1007/s10096-021-04399-9. Epub 2022 Jan 13.

ReferenceCitation: Wenzler E, Butler D, Tan X, Katsube T, Wajima T. Pharmacokinetics, Pharmacodynamics, and Dose Optimization of Cefiderocol during Continuous Renal Replacement Therapy. Clin Pharmacokinet. 2022 Apr;61(4):539-552. doi: 10.1007/s40262-021-01086-y. Epub 2021 Nov 18. Erratum in: Clin Pharmacokinet. 2022 Jul;61(7):1069.

ReferenceCitation: Wunderink RG, Matsunaga Y, Ariyasu M, Clevenbergh P, Echols R, Kaye KS, Kollef M, Menon A, Pogue JM, Shorr AF, Timsit JF, Zeitlinger M, Nagata TD. Cefiderocol versus high-dose, extended-infusion meropenem for the treatment of Gram-negative nosocomial pneumonia (APEKS-NP): a randomised, double-blind, phase 3, non-inferiority trial. Lancet Infect Dis. 2021 Feb;21(2):213-225. doi: 10.1016/S1473-3099(20)30731-3. Epub 2020 Oct 12.

ipd_sharing: No

lead_sponsor: Shionogi

location_country:
Taiwan
Serbia
Spain
Latvia
Georgia
Estonia
Russian Federation
Canada
Ukraine
Hungary
Philippines
Puerto Rico
United States
France
Israel
Belgium
Japan
Germany
Czechia

intervention_type: Drug

status_simplified: Completed


status: Active, not recruiting

acronym: PERSPECTIVE

title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib, in Combination With Rituximab Versus Placebo in Combination With Rituximab in Treatment Naïve Subjects With Follicular Lymphoma (PERSPECTIVE)

lead_sponsor: Pharmacyclics LLC.

location_country:
Poland
Taiwan
Portugal
Spain
Greece
Austria
Australia
Italy
Canada
New Zealand
Russian Federation
United Kingdom
Hungary
United States
France
Israel
Turkey
Belgium
Netherlands
Czechia

location_facility: Gazi Universitesi Tip Fakultesi Hastanesi

location_facility: Ege Universitesi Tip Fakultesi Hastanesi

location_facility: Roy and Patricia Disney Family Cancer Center

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Centro Hospitalar do Porto - Hospital de Santo António

location_facility: Dokuz Eylul Universitesi Tip Fakultesi Hastanesi

location_facility: Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

location_facility: North-West Federal Medical Research Center n.a. V.A. Almazov

location_facility: Georgios Papanikolaou General Hospital of Thessaloniki

location_facility: Erciyes Universitesi Tip Fakultesi Hastanesi

location_facility: Mersin Universitesi Tip Fakultesi Hastanesi

location_facility: OHSU Knight Cancer Institute Beaverton Clinic

location_facility: Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST

location_facility: Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii

location_facility: Policlinico Universitario Campus Biomedico di Roma

location_facility: W VA University Mary Babb Randolph Cancer Center

location_facility: Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi

location_facility: Oncology and Hematology Associates of Southwest Virginia (Blacksburg)

location_facility: SCRI The Center For Cancer and Blood Disorders

location_facility: Azienda Ospedaliera Ospedali Riuniti Villa Sofia-Cervello

location_facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

location_facility: Helen F. Graham Cancer Center and Research Institute

location_facility: Royal Berkshire Hospital NHS Foundation Trust

location_facility: Azienda Ospedaliera Città della Salute e della Scienza di Torino

location_facility: Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im.M.Kopernika

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: Azienda ospedaliera Universiataria Senese

location_facility: ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

location_facility: Centro Hospitalar Lisboa Norte, E.P.E. Hospital de Santa Maria

location_facility: Azienda Ospedaliero Universitaria Di Bologna - Policlinico S Orsola Malpighi

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: Hospital Universitario HM Sanchinarro - CIOCC

location_facility: Namik Kemal Universitesi Tip Fakultesi Hastanesi

location_facility: Royal Cornwall Hospital - Hospital Treliske

location_facility: Theageneio Anticancer Oncology Hospital of Thessaloniki

location_facility: Hospital Clinico Universitario de Valladolid

location_facility: Chang Gung Medical Foundation Kaohsiung Chang Gung Memorial Hospital

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 we Wroclawiu

location_facility: Russian Oncology Research Center n a N N Blokhin

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Texas Oncology-Dallas Presbyterian Hospital

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: Azienda Sanitaria Ospedaliera S. Croce e Carle

location_facility: Farmacia Polo Ematologico Policlinico Umberto I

location_facility: Istanbul Universitesi Istanbul Tip Fakultesi Hastanesi

location_facility: University of Texas Southwestern Medical Center

location_facility: Nizhegorodskaya Regional Clinical Hospital n.a. Semashko

summary: The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma.


ipd_sharing: Yes

title: A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the FLT3 Inhibitor Gilteritinib (ASP2215) Administered as Maintenance Therapy Following Induction/Consolidation Therapy for Subjects With FLT3/ITD AML in First Complete Remission

lead_sponsor: Astellas Pharma Global Development, Inc.

ipd_sharing_description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Romania
Japan
Czechia
Poland
Portugal
Israel
Sweden
Brazil
Canada
Hungary
Germany
Denmark
Taiwan
Greece
Korea, Republic of
France

location_facility:
Site PT35101
Site GR30010
Site US10029
Site IT39005
Site JP81023
Site JP81024
Site GB44015
Site IT39010
Site KR82003
Site JP81012
Site RO40005
Site US10012
Site US10007
Site BR55002
Site KR82014
Site JP81011
Site KR82012
Site PL48007
Site ES34009
Site US10030
Site CZ42001
Site FR33008
Site GB44019
Site GB44004
Site PL48002
Site IT39004
Site IT39002
Site JP81002
Site JP81004
Site JP81010
Site FR33014
Site KR82009
Site JP81025
Site FR33007
Site DE49001
Site KR82005
Site GB44002
Site GB44007
Site IT39011
Site FR33002
Site DE49008
Site SE46003
Site DK45002
Site JP81017
Site RS38102
Site CA15001
Site GR30004
Site FR33004
Site KR82006
Site TW88605
Site FR33009
Site HU36003
Site KR82013
Site FR33001
Site PT35106
Site GB44020
Site US10025
Site IL97205
Site SE46002
Site CA15003
Site GR30009
Site GR30007
Site IT39008
Site PL48001
Site TW88603
Site GB44006
Site TW88604
Site GB44018
Site KR82008
Site JP81014
Site US10017
Site JP81009
Site JP81018

summary: The purpose of this study was to compare relapse-free survival (RFS) between participants with FMS-like tyrosine kinase 3 (FLT3) / internal tandem duplication (ITD) acute myeloid leukemia (AML) in first complete remission (CR1) and who were randomized to receive gilteritinib or placebo beginning after completion of induction/consolidation chemotherapy for a two-year period.


title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults With Active Primary Sjögrens Syndrome

location_country:
Brazil
Italy
Australia
Argentina
Sweden
Korea, Republic of
United States
France
Puerto Rico
Mexico
Japan
Germany
Czechia

location_facility: Instituto de Asistencia Reumatologica Integral

location_facility: Joint and Muscle Medical Care and Research Institute (JMMCRI)

location_facility: Organizacion Medica De Investigacion S.A. (Omi)

location_facility: Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi S.C.

location_facility: Consultorio Medico de Reumatologia Dr.Jesus Alberto Lopez Garcia

location_facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez

location_facility: Duke Clinical Research Unit, Duke Univ Med Ctr, Duke South

summary: The purpose of this study is to evaluate the efficacy of abatacept compared to placebo in patients with Sjögren's Syndrome.


title: A Randomized, 24-Week Treatment, Double-blind, Placebo-controlled Efficacy and Safety Study of Dupilumab 300 mg Every Other Week, in Patients With Bilateral Nasal Polyposis on a Background Therapy With Intranasal Corticosteroids

lead_sponsor: Sanofi

type: Other Identifier

ReferenceCitation: Peters AT, Soler ZM, Kern RC, Heffler E, Maspero JF, Crampette L, Fujieda S, Lane AP, Zhang H, Nash S, Khan AH, Siddiqui S, Jacob-Nara JA, Rowe P, Deniz Y. Improvement in patient-reported "taste" and association with smell in dupilumab-treated patients with severe chronic rhinosinusitis with nasal polyps from the SINUS-24 and SINUS-52 trials. Clin Exp Allergy. 2022 Sep;52(9):1105-1109. doi: 10.1111/cea.14194. Epub 2022 Jul 12.

ReferenceCitation: Wechsler ME, Klion AD, Paggiaro P, Nair P, Staumont-Salle D, Radwan A, Johnson RR, Kapoor U, Khokhar FA, Daizadeh N, Chen Z, Laws E, Ortiz B, Jacob-Nara JA, Mannent LP, Rowe PJ, Deniz Y. Effect of Dupilumab on Blood Eosinophil Counts in Patients With Asthma, Chronic Rhinosinusitis With Nasal Polyps, Atopic Dermatitis, or Eosinophilic Esophagitis. J Allergy Clin Immunol Pract. 2022 Oct;10(10):2695-2709. doi: 10.1016/j.jaip.2022.05.019. Epub 2022 May 28.

ReferenceCitation: Bachert C, Peters AT, Heffler E, Han JK, Olze H, Pfaar O, Chuang CC, Rout R, Attre R, Goga L, Jacob-Nara JA, Rowe PJ, Deniz Y, Chen Z, Kamat S, Siddiqui S. Responder analysis to demonstrate the effect of targeting type 2 inflammatory mechanisms with dupilumab across objective and patient-reported endpoints for patients with severe chronic rhinosinusitis with nasal polyps in the SINUS-24 and SINUS-52 studies. Clin Exp Allergy. 2022 Feb;52(2):244-249. doi: 10.1111/cea.14051.

ReferenceCitation: Lee SE, Hopkins C, Mullol J, Msihid J, Guillemin I, Amin N, Mannent LP, Li Y, Siddiqui S, Chuang CC, Kamat S, Khan AH. Dupilumab improves health related quality of life: Results from the phase 3 SINUS studies. Allergy. 2022 Jul;77(7):2211-2221. doi: 10.1111/all.15222. Epub 2022 Feb 1.

ReferenceCitation: Bachert C, Corren J, Lee SE, Zhang H, Harel S, Cunoosamy D, Khan AH, Jacob-Nara JA, Siddiqui S, Nash S, Rowe PJ, Deniz Y. Dupilumab efficacy and biomarkers in chronic rhinosinusitis with nasal polyps: Association between dupilumab treatment effect on nasal polyp score and biomarkers of type 2 inflammation in patients with chronic rhinosinusitis with nasal polyps in the phase 3 SINUS-24 and SINUS-52 trials. Int Forum Allergy Rhinol. 2022 Sep;12(9):1191-1195. doi: 10.1002/alr.22964. Epub 2022 Jan 31.

ReferenceCitation: Hellings PW, Peters AT, Chaker AM, Heffler E, Zhang H, Praestgaard A, Nash S, Khan AH, Siddiqui S, Jacob-Nara JA, Rowe PJ, Deniz Y. Rapid and sustained effects of dupilumab in severe chronic rhinosinusitis with nasal polyps. Int Forum Allergy Rhinol. 2022 Jul;12(7):958-962. doi: 10.1002/alr.22944. Epub 2022 Jan 23.

ReferenceCitation: Han JK, Bachert C, Lee SE, Hopkins C, Heffler E, Hellings PW, Peters AT, Kamat S, Whalley D, Qin S, Nelson L, Siddiqui S, Khan AH, Li Y, Mannent LP, Guillemin I, Chuang CC. Estimating Clinically Meaningful Change of Efficacy Outcomes in Inadequately Controlled Chronic Rhinosinusitis with Nasal Polyposis. Laryngoscope. 2022 Feb;132(2):265-271. doi: 10.1002/lary.29888. Epub 2021 Dec 1.

ReferenceCitation: Chuang CC, Guillemin I, Bachert C, Lee SE, Hellings PW, Fokkens WJ, Duverger N, Fan C, Daizadeh N, Amin N, Mannent LP, Khan AH, Kamat S. Dupilumab in CRSwNP: Responder Analysis Using Clinically Meaningful Efficacy Outcome Thresholds. Laryngoscope. 2022 Feb;132(2):259-264. doi: 10.1002/lary.29911. Epub 2021 Nov 24.

ReferenceCitation: Mullol J, Laidlaw TM, Bachert C, Mannent LP, Canonica GW, Han JK, Maspero JF, Picado C, Daizadeh N, Ortiz B, Li Y, Ruddy M, Laws E, Amin N. Efficacy and safety of dupilumab in patients with uncontrolled severe chronic rhinosinusitis with nasal polyps and a clinical diagnosis of NSAID-ERD: Results from two randomized placebo-controlled phase 3 trials. Allergy. 2022 Apr;77(4):1231-1244. doi: 10.1111/all.15067. Epub 2021 Oct 1.

ReferenceCitation: Khan AH, Reaney M, Guillemin I, Nelson L, Qin S, Kamat S, Mannent L, Amin N, Whalley D, Hopkins C. Development of Sinonasal Outcome Test (SNOT-22) Domains in Chronic Rhinosinusitis With Nasal Polyps. Laryngoscope. 2022 May;132(5):933-941. doi: 10.1002/lary.29766. Epub 2021 Aug 26.

ReferenceCitation: Chong LY, Piromchai P, Sharp S, Snidvongs K, Webster KE, Philpott C, Hopkins C, Burton MJ. Biologics for chronic rhinosinusitis. Cochrane Database Syst Rev. 2021 Mar 12;3:CD013513. doi: 10.1002/14651858.CD013513.pub3.

ReferenceCitation: Hopkins C, Wagenmann M, Bachert C, Desrosiers M, Han JK, Hellings PW, Lee SE, Msihid J, Radwan A, Rowe P, Amin N, Deniz Y, Ortiz B, Mannent LP, Rout R. Efficacy of dupilumab in patients with a history of prior sinus surgery for chronic rhinosinusitis with nasal polyps. Int Forum Allergy Rhinol. 2021 Jul;11(7):1087-1101. doi: 10.1002/alr.22780. Epub 2021 Feb 21.

ReferenceCitation: Peters AT, Han JK, Hellings P, Heffler E, Gevaert P, Bachert C, Xu Y, Chuang CC, Neupane B, Msihid J, Mannent LP, Guyot P, Kamat S. Indirect Treatment Comparison of Biologics in Chronic Rhinosinusitis with Nasal Polyps. J Allergy Clin Immunol Pract. 2021 Jun;9(6):2461-2471.e5. doi: 10.1016/j.jaip.2021.01.031. Epub 2021 Feb 4.

ReferenceCitation: Laidlaw TM, Bachert C, Amin N, Desrosiers M, Hellings PW, Mullol J, Maspero JF, Gevaert P, Zhang M, Mao X, Khan AH, Kamat S, Patel N, Graham NMH, Ruddy M, Staudinger H, Mannent LP. Dupilumab improves upper and lower airway disease control in chronic rhinosinusitis with nasal polyps and asthma. Ann Allergy Asthma Immunol. 2021 May;126(5):584-592.e1. doi: 10.1016/j.anai.2021.01.012. Epub 2021 Jan 16.

ReferenceCitation: Bachert C, Han JK, Desrosiers M, Hellings PW, Amin N, Lee SE, Mullol J, Greos LS, Bosso JV, Laidlaw TM, Cervin AU, Maspero JF, Hopkins C, Olze H, Canonica GW, Paggiaro P, Cho SH, Fokkens WJ, Fujieda S, Zhang M, Lu X, Fan C, Draikiwicz S, Kamat SA, Khan A, Pirozzi G, Patel N, Graham NMH, Ruddy M, Staudinger H, Weinreich D, Stahl N, Yancopoulos GD, Mannent LP. Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials. Lancet. 2019 Nov 2;394(10209):1638-1650. doi: 10.1016/S0140-6736(19)31881-1. Epub 2019 Sep 19. Erratum in: Lancet. 2019 Nov 2;394(10209):1618.

ipd_sharing_description: Not yet available

location_country:
Poland
United Kingdom
Italy
Russian Federation
Netherlands
Ukraine
Hungary
United States
France
Romania
Germany
Bulgaria
Czechia

location_facility:
Investigational Site Number 3480005
Investigational Site Number 6430002
Investigational Site Number 2500002
Investigational Site Number 5280001
Investigational Site Number 6160001
Investigational Site Number 6420007
Investigational Site Number 8040008
Investigational Site Number 8260001
Investigational Site Number 8400003
Investigational Site Number 6160002
Investigational Site Number 2030001
Investigational Site Number 6420008
Investigational Site Number 8400008
Investigational Site Number 8400009
Investigational Site Number 2500003
Investigational Site Number 6160003
Investigational Site Number 3800002
Investigational Site Number 3480004
Investigational Site Number 8400019
Investigational Site Number 2500001
Investigational Site Number 6420003
Investigational Site Number 2760003
Investigational Site Number 6430006
Investigational Site Number 6430004
Investigational Site Number 8400014
Investigational Site Number 3800006
Investigational Site Number 8400020
Investigational Site Number 2760002
Investigational Site Number 2500007
Investigational Site Number 8400021
Investigational Site Number 8400007
Investigational Site Number 2500006
Investigational Site Number 8260002
Investigational Site Number 8400004
Investigational Site Number 2500005
Investigational Site Number 6420010
Investigational Site Number 6430007
Investigational Site Number 3800007
Investigational Site Number 8260004
Investigational Site Number 8260006
Investigational Site Number 3800001
Investigational Site Number 1000003
Investigational Site Number 8400010
Investigational Site Number 6420013
Investigational Site Number 6420009
Investigational Site Number 8400016
Investigational Site Number 8400005
Investigational Site Number 8040001
Investigational Site Number 1000001
Investigational Site Number 8040005
Investigational Site Number 6430003
Investigational Site Number 8260007
Investigational Site Number 8400001
Investigational Site Number 8040006
Investigational Site Number 8400002
Investigational Site Number 3480006
Investigational Site Number 2500004
Investigational Site Number 3800003
Investigational Site Number 6430001
Investigational Site Number 3480001
Investigational Site Number 3800005
Investigational Site Number 3480003
Investigational Site Number 8400018
Investigational Site Number 2030002
Investigational Site Number 3800004
Investigational Site Number 3480002
Investigational Site Number 2030004
Investigational Site Number 8040004
Investigational Site Number 8400015
Investigational Site Number 8260005
Investigational Site Number 8400022
Investigational Site Number 2760001
Investigational Site Number 8400013
Investigational Site Number 8040002
Investigational Site Number 3480007
Investigational Site Number 1000002

summary:
Primary Objective:

To evaluate the efficacy of dupilumab 300 milligram (mg) every 2 weeks (q2w) compared to placebo on a background of mometasone furoate nasal spray (MFNS) in reducing nasal congestion/obstruction (NC) severity and endoscopic nasal polyp score (NPS) in participants with bilateral nasal polyposis (NP). In addition for Japan participants, reduction in computed tomography (CT) scan opacification of the sinuses was a coprimary objective.

Secondary Objectives:

To evaluate the efficacy of dupilumab in improving total symptoms score (TSS).
To evaluate the efficacy of dupilumab in improving sense of smell.
To evaluate the efficacy of dupilumab in reducing CT scan opacification of the sinuses (primary objective for Japan).
To evaluate ability of dupilumab in reducing proportion of participants requiring treatment with systemic corticosteroids or NP surgery.
To evaluate the effect of dupilumab on participant reported outcomes and health related quality of life outcome by sinonasal outcome test-22 (SNOT-22).
To evaluate the effect of dupilumab in the subgroups of participants with prior surgery and co-morbid asthma (including non-steroid antiinflammatory drug [NSAID] exacerbated respiratory disease [ERD]).
To evaluate residual effect in follow up.
To evaluate the safety of dupilumab in participants with bilateral NP.
To evaluate functional dupilumab concentrations (systemic exposure) and incidence of treatment-emergent anti-drug antibodies.


acronym: TRIDENT

title: A Phase 2b, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Safety and Efficacy of JnJ-64304500 in Subjects With Moderately to Severely Active Crohn's Disease

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Romania
United Kingdom
Russian Federation
Canada
Ukraine
Hungary
Korea, Republic of
United States
France
Belgium
Japan
Germany
Bulgaria

summary: The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.


title: An Open-Label, Multicenter Study With an Extension Phase to Evaluate the Safety, Tolerability, and Exposure-Efficacy Relationship of Perampanel Oral Suspension When Administered as an Adjunctive Therapy in Pediatric Subjects (Age 4 to Less Than 12 Years) With Inadequately Controlled Partial-Onset Seizures or Primary Generalized Tonic Clonic Seizures

summary: This is an open-label, multicenter study with an Extension Phase to evaluate the safety and tolerability of perampanel oral suspension when administered as an adjunctive therapy in children (ages 4 to less than [<] 12 years) with inadequately controlled partial onset seizures (POS) or primary generalized tonic clonic (PGTC) seizures.

ReferenceCitation: Trigg A, Brohan E, Cocks K, Jones A, Tahami Monfared AA, Chabot I, Meier G, Campbell R, Li H, Ngo LY. Health-related quality of life in pediatric patients with partial onset seizures or primary generalized tonic-clonic seizures receiving adjunctive perampanel. Epilepsy Behav. 2021 May;118:107938. doi: 10.1016/j.yebeh.2021.107938. Epub 2021 Apr 8.

ReferenceCitation: Fogarasi A, Flamini R, Milh M, Phillips S, Yoshitomi S, Patten A, Takase T, Laurenza A, Ngo LY. Open-label study to investigate the safety and efficacy of adjunctive perampanel in pediatric patients (4 to <12 years) with inadequately controlled focal seizures or generalized tonic-clonic seizures. Epilepsia. 2020 Jan;61(1):125-137. doi: 10.1111/epi.16413. Epub 2020 Jan 7.

lead_sponsor: Eisai Inc.

location_country:
Poland
Spain
Italy
Latvia
Canada
Hungary
Korea, Republic of
France
United States
Belgium
Japan
Czechia

location_facility:
Eisai Trial Site #1
Facility #1
Facility #3
Facility #2


title: A Double Blind Placebo Controlled Study to Evaluate the Effect of Bexagliflozin Tablets on Hemoglobin A1c in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment

summary: This was a phase 3, multi-center, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of oral administration of bexagliflozin at 20 mg versus placebo in subjects with T2DM, moderate renal impairment and inadequate glycemic control.

lead_sponsor: Theracos

location_country:
Japan
United States
Spain
France

location_facility:
Research site
Research Site


acronym: BEIJERINCK

title: A Double Blind, Randomized, Placebo Controlled, Multicenter Study to Evaluate Safety, Tolerability, and Efficacy on LDL-C of Evolocumab (AMG 145) in Subjects With HIV and With Hyperlipidemia and/or Mixed Dyslipidemia

lead_sponsor: Amgen

ReferenceType: background

ReferenceCitation: Boccara F, Kumar PN, Caramelli B, Calmy A, López JAG, Bray S, Cyrille M, Rosenson RS; BEIJERINCK Investigators. Evolocumab in HIV-Infected Patients With Dyslipidemia: Primary Results of the Randomized, Double-Blind BEIJERINCK Study. J Am Coll Cardiol. 2020 May 26;75(20):2570-2584. doi: 10.1016/j.jacc.2020.03.025. Epub 2020 Mar 28. Erratum in: J Am Coll Cardiol. 2020 Aug 11;76(6):762-765.

ReferenceCitation: Boccara F, Kumar P, Caramelli B, Calmy A, López JAG, Bray S, Cyrille M, Rosenson RS. Evolocumab treatment in patients with HIV and hypercholesterolemia/mixed dyslipidemia: BEIJERINCK study design and baseline characteristics. Am Heart J. 2020 Feb;220:203-212. doi: 10.1016/j.ahj.2019.11.004. Epub 2019 Nov 12.

ReferenceCitation: Boccara F, Caramelli B, Calmy A, Kumar P, López JAG, Bray S, Cyrille M, Rosenson RS; investigators of the BEIJERINCK study. Long-term effects of evolocumab in participants with HIV and dyslipidemia: results from the open-label extension period. AIDS. 2022 Apr 1;36(5):675-682. doi: 10.1097/QAD.0000000000003175.

ReferenceCitation: Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10:CD011748. doi: 10.1002/14651858.CD011748.pub3.

ipd_sharing_description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request

location_country:
Poland
Brazil
Portugal
Romania
Greece
Italy
Australia
Spain
Canada
United Kingdom
Switzerland
United States
France
South Africa
Belgium

summary:
The study is divided into 2 parts. The first part of the study will be double-blinded and will last for 24 weeks. During this time, participants will be randomized in a ratio of 2:1 to receive either evolocumab once monthly (QM) or placebo QM. The second part of the study is a 24-week open label extension period. During this time all participants will receive evolocumab QM.

The clinical hypothesis is that subcutaneous evolocumab QM will be well tolerated and will result in greater reduction of low density lipoprotein cholesterol (LDL-C), defined as percent change from baseline at Week 24, compared with placebo QM in human immunodeficiency virus (HIV)-positive participants with hyperlipidemia or mixed dyslipidemia.


acronym: ASCLEPIOS II

title: A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis.

lead_sponsor: Novartis Pharmaceuticals

ReferenceCitation: Gärtner J, Hauser SL, Bar-Or A, Montalban X, Cohen JA, Cross AH, Deiva K, Ganjgahi H, Häring DA, Li B, Pingili R, Ramanathan K, Su W, Willi R, Kieseier B, Kappos L. Efficacy and safety of ofatumumab in recently diagnosed, treatment-naive patients with multiple sclerosis: Results from ASCLEPIOS I and II. Mult Scler. 2022 Sep;28(10):1562-1575. doi: 10.1177/13524585221078825. Epub 2022 Mar 10.

ReferenceCitation: Hauser SL, Bar-Or A, Cohen JA, Comi G, Correale J, Coyle PK, Cross AH, de Seze J, Leppert D, Montalban X, Selmaj K, Wiendl H, Kerloeguen C, Willi R, Li B, Kakarieka A, Tomic D, Goodyear A, Pingili R, Häring DA, Ramanathan K, Merschhemke M, Kappos L; ASCLEPIOS I and ASCLEPIOS II Trial Groups. Ofatumumab versus Teriflunomide in Multiple Sclerosis. N Engl J Med. 2020 Aug 6;383(6):546-557. doi: 10.1056/NEJMoa1917246.

ipd_sharing_description:
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
United States
Peru
Belgium
South Africa
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Argentina
India
Turkey
Mexico
Norway
Slovakia
Canada
Switzerland
Hungary
Germany
Bulgaria
Taiwan
Latvia
Finland
France

summary: To compare the efficacy and safety of ofatumumab administered subcutaneously (sc) every 4 weeks versus teriflunomide administered orally once daily in patients with relapsing multiple sclerosis


title: A PHASE 3 MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY OF DAILY ORAL DOSING OF TAFAMIDIS MEGLUMINE (PF-06291826-83) 20 MG OR 80 MG [OR TAFAMIDIS (PF-06291826-00) 61 MG] IN SUBJECTS DIAGNOSED WITH TRANSTHYRETIN CARDIOMYOPATHY (ATTR-CM)

summary: Open label study to evaluate tafamidis for the treatment of transthyretin cardiomyopathy

ReferenceCitation: Elliott P, Drachman BM, Gottlieb SS, Hoffman JE, Hummel SL, Lenihan DJ, Ebede B, Gundapaneni B, Li B, Sultan MB, Shah SJ. Long-Term Survival With Tafamidis in Patients With Transthyretin Amyloid Cardiomyopathy. Circ Heart Fail. 2022 Jan;15(1):e008193. doi: 10.1161/CIRCHEARTFAILURE.120.008193. Epub 2021 Dec 20.

ReferenceCitation: Damy T, Garcia-Pavia P, Hanna M, Judge DP, Merlini G, Gundapaneni B, Patterson TA, Riley S, Schwartz JH, Sultan MB, Witteles R. Efficacy and safety of tafamidis doses in the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial (ATTR-ACT) and long-term extension study. Eur J Heart Fail. 2021 Feb;23(2):277-285. doi: 10.1002/ejhf.2027. Epub 2020 Nov 12.

ReferenceCitation: Li B, Alvir J, Stewart M. Extrapolation of Survival Benefits in Patients with Transthyretin Amyloid Cardiomyopathy Receiving Tafamidis: Analysis of the Tafamidis in Transthyretin Cardiomyopathy Clinical Trial. Cardiol Ther. 2020 Dec;9(2):535-540. doi: 10.1007/s40119-020-00179-2. Epub 2020 Jun 10.

ipd_sharing_description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

lead_sponsor: Pfizer

location_country:
Taiwan
Brazil
Hong Kong
Spain
Italy
United Kingdom
Australia
Netherlands
Argentina
Canada
Sweden
United States
France
Belgium
Japan
Germany
Czechia

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Institut klinicke a experimentalni mediciny

location_facility: Cardiovascular Clinical Trials Unit (CCTU)

location_facility: University of Utah, Division of Cardiovascular Medicine

location_facility: Columbia University Medical Center- Clinical Cardiovascular Research Laboratory for the Elderly

location_facility: University of Calgary/Foothills Medical Centre

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Montreal Heart Institute-Research Center

location_facility: Stanford University Hospital and Clinics

location_facility: Hospital Universitário Clementino Fraga Filho (UFRJ)

location_facility: Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: UCSF Cardiovascular Care and Prevention Center

location_facility: University Hospital, University of Alabama at Birmingham

location_facility: Michigan Medicine,University of Michigan

location_facility: University of California, San Diego Medical Center - Hillcrest

location_facility: Instituto Cardiovascular de Buenos Aires

location_facility: Altman Clinical Translational Research Institute

location_facility: University health network-Toronto General Hospital

location_facility: Stanford Hospital and Clinics Investigational Pharmacy

location_facility: Barts Health NHS Trust, St Bartholomew's Hospital

location_facility: Boston Medical Center Investigational Pharmacy

location_facility: Gordon and Leslie Diamond Health Care Centre

location_facility: Michigan Medicine - Department of Pharmacy Services - Research Pharmacy

location_facility: University of Miami Hospital & Clinics/Sylvester Comprehensive Cancer Center


title: A 12-week, Double Blind, Randomised, Placebo Controlled, Parallel Group Trial Followed by a Single Active Arm Phase of 40 Weeks Evaluating the Effect of Oral Nintedanib 150 mg Twice Daily on Change in Biomarkers of Extracellular Matrix (ECM) Turnover in Patients With Idiopathic Pulmonary Fibrosis (IPF) and Limited Forced Vital Capacity (FVC) Impairment.

lead_sponsor: Boehringer Ingelheim

ReferenceCitation: Glaspole I, Bonella F, Bargagli E, Glassberg MK, Caro F, Stansen W, Quaresma M, Orsatti L, Bendstrup E. Efficacy and safety of nintedanib in patients with idiopathic pulmonary fibrosis who are elderly or have comorbidities. Respir Res. 2021 Apr 26;22(1):125. doi: 10.1186/s12931-021-01695-y.

ReferenceCitation: Noth I, Cottin V, Chaudhuri N, Corte TJ, Johannson KA, Wijsenbeek M, Jouneau S, Michael A, Quaresma M, Rohr KB, Russell AM, Stowasser S, Maher TM; INMARK trial investigators. Home spirometry in patients with idiopathic pulmonary fibrosis: data from the INMARK trial. Eur Respir J. 2021 Jul 8;58(1). pii: 2001518. doi: 10.1183/13993003.01518-2020. Print 2021 Jul.

ReferenceCitation: Maher TM, Stowasser S, Nishioka Y, White ES, Cottin V, Noth I, Selman M, Rohr KB, Michael A, Ittrich C, Diefenbach C, Jenkins RG; INMARK trial investigators. Biomarkers of extracellular matrix turnover in patients with idiopathic pulmonary fibrosis given nintedanib (INMARK study): a randomised, placebo-controlled study. Lancet Respir Med. 2019 Sep;7(9):771-779. doi: 10.1016/S2213-2600(19)30255-3. Epub 2019 Jul 17.

ReferenceCitation: Maher TM, Stowasser S, Nishioka Y, White ES, Cottin V, Noth I, Selman M, Blahova Z, Wachtlin D, Diefenbach C, Jenkins RG. Investigating the effects of nintedanib on biomarkers of extracellular matrix turnover in patients with IPF: design of the randomised placebo-controlled INMARK®trial. BMJ Open Respir Res. 2018 Aug 20;5(1):e000325. doi: 10.1136/bmjresp-2018-000325. eCollection 2018.

location_country:
Poland
Spain
United Kingdom
Australia
Finland
Hungary
Korea, Republic of
United States
France
Belgium
Japan
Germany
Czechia

location_facility: Our Doctor Clinical Trial Center, Department in Bydgoszcz

location_facility: BAZ County Central Hospital and University Teaching Hospital

location_facility: Practice of Internists "Nasz Lekarz", Torun

location_facility: Klinikum der Universität München - Campus Großhadern

location_facility: Norbert Barlicki University Clinical Hospital No.1, Lodz

location_facility: Concord General Repatriation Hospital -Ambulatory Care Unit

location_facility: Pulmonology Institute of Veszprem County, Farkasgyepu

location_facility: Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg

location_facility: University of Florida College of Medicine

location_facility: Universitätsklinikum Gießen und Marburg GmbH

location_facility: Kanagawa Cardiovascular and Respiratory Center

location_facility: Seoul National University Bundang Hospital

location_facility: Non-pub.Health Care NZOZ Profilaktyka W. Pierzchala,Katowice

location_facility: Univ. Hospital in Krakow,Pulmonology Clinical Dept

location_facility: Centre Hospitalier Universitaire de Liège

location_facility: National Hospital Organization Kinki-Chuo Chest Medical Center

location_facility: Pneumologisches Forschungsinstitut an der LungenClinic Grosshansdorf GmbH

summary: Identifying biomarkers to predict the clinical course and benefits of therapy early in the course of the disease remains one of the most urgent and relevant challenges to improve overall patient management, to prevent treatment delay or overtreatment. This study is conducted to examine the effect of nintedanib treatment on change in biomarkers indicative of extracellular matrix turnover which have been shown recently to correlate with disease progression. This study further aims to confirm the association of biomarker course during the first three months of treatment and disease progression.


title: An Open-label Long-term Extension Safety Study of Esketamine Nasal Spray in Treatment-resistant Depression

summary: The purpose of this study is to assess the safety and tolerability of esketamine nasal spray in participants with treatment-resistant depression (TRD).

ReferenceCitation: Starr HL, Abell J, Larish A, Lewis S, DeMuro C, Gogate J, Jamieson C, Daly E, Zaki N, Kramer M. Self-reported review of the value of esketamine in patients with treatment-resistant depression: Understanding the patient experience in the STRIVE Study. Psychiatry Res. 2020 Nov;293:113376. doi: 10.1016/j.psychres.2020.113376. Epub 2020 Aug 8.

location_country:
Spain
United Kingdom
Lithuania
United States
South Africa
Belgium
Czechia
Poland
Austria
Australia
Argentina
Turkey
Mexico
Malaysia
Sweden
Slovakia
Brazil
Canada
Hungary
Germany
Bulgaria
Taiwan
Estonia
Finland
Korea, Republic of
France


status: Terminated

acronym: Omaspect

title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Lampalizumab in Patients With Geographic Atrophy Secondary to Age-Related Macular Degeneration Who Have Completed a Roche-Sponsored Study

lead_sponsor: Hoffmann-La Roche

design_allocation: Non-Randomized

location_country:
Denmark
Poland
Portugal
Spain
Italy
Austria
Australia
Netherlands
Canada
United Kingdom
Switzerland
Hungary
United States
France
Peru
Turkey
Belgium
Germany
Slovakia

location_facility: Hospital Perpetuo Socorro; Servicio de Oftalmología

location_facility: Medizinische Hochschule Hannover, Klinik für Augenheilkunde

location_facility: Semmelweis Egyetem AOK, Szemeszeti Klinika

location_facility: Klinikum rechts der Isar der TU München; Augenklinik

location_facility: A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

location_facility: University of Michigan, Kellogg Eye Center

location_facility: Fakultna nemocnica s poliklinikou Zilina; Ocne oddelenie

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: A.S.L. to1 Presidio Ospedaliero Sperino Oftalmico

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Retina-Vitreous Associates Medical Group

location_facility: Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

location_facility: Cleveland Clinic Foundation; Cole Eye Institute

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: AIBILI - Association for Innovation and Biomedical Research on Light

location_facility: Uniwersytecki Szpital Kliniczny; Klinika Okulistyki

location_facility: Universitätsklinikum Regensburg, Klinik & Poliklinik für Augenheilkunde

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Centre Monticelli Paradis d Ophtalmologie

location_facility: Kepler Universitätskliniken GmbH - Med Campus III; Abt. für Augenheilkunde

location_facility: Irccs Ospedale San Raffaele;U.O. Oculistica

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

location_facility: Duke University Eye Center; Vitreoretinal

location_facility: The Royal Wolverhampton Hospitals NHS Trust

location_facility: SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Uni of Alabama At Birmingham Clinical Research Unit

location_facility: Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

location_facility: Instituto Clinico Quirurgico de Oftalmologia - ICQO

location_facility: Universitätskliniikum Schleswig-Holstein, Campus Lübeck, Klinik für Augenheilkunde

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: Macular Treatment Centre; Royal Eye Hospital

location_facility: Centre Odeon; Exploration Ophtalmologique

location_facility: Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik

location_facility: Glostrup Hospital, Øjenafdelingen, Forskningsafsnit Ø37

location_facility: Southeastern Retina Associates Chattanooga

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: FISABIO. Fundación Oftalmologica del Mediterraneo

location_facility: Univerzitna nemocnica Bratislava, Nemocnica sv. Cyrila a Metoda Ocna klinika SZU a UNB

location_facility: University of California, Davis, Eye Center

location_facility: Hospital de Santa Maria; Servico de Oftalmologia

location_facility: UCSF Comprehensive Cancer Ctr; Ophthalmology

location_facility: UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

location_facility: Hospital Universitari de Bellvitge; Servicio de Oftalmologia

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Eye Surgeons of Richmond Inc. dba Virginia Eye Institute

location_facility: Retina & Vitreous Center of Southern Oregon

location_facility: Inselspital Bern, Universitätsklinik für Augenheilkunde

location_facility: LMU Klinikum der Universität, Augenklinik

summary: This multicenter open-label extension study is designed to evaluate the safety and tolerability of lampalizumab intravitreal injections in participants with GA secondary to age-related macular degeneration (AMD) who completed 96 weeks of treatment in Studies GX29176 (NCT02247479) or GX29185 (NCT02247531). The extension will enroll participants from the parent studies who received investigational lampalizumab, as well as lampalizumab-naive participants exposed to sham comparator. All participants will receive open-label lampalizumab in the present study.

status_simplified: Unknown


acronym: EXCEED 1

title: A Randomized, Double-blind, Active Control, Multicenter Study to Evaluate the Efficacy at Week 52 of Secukinumab Monotherapy Compared With Adalimumab Monotherapy in Patients With Active Psoriatic Arthritis

ReferenceCitation: McInnes IB, Behrens F, Mease PJ, Kavanaugh A, Ritchlin C, Nash P, Masmitja JG, Goupille P, Korotaeva T, Gottlieb AB, Martin R, Ding K, Pellet P, Mpofu S, Pricop L; EXCEED Study Group. Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial. Lancet. 2020 May 9;395(10235):1496-1505. doi: 10.1016/S0140-6736(20)30564-X. Erratum in: Lancet. 2020 May 30;395(10238):1694.

ipd_sharing_description:
Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

location_country:
Spain
Italy
United Kingdom
Lithuania
United States
Iceland
Czechia
Poland
Portugal
Russian Federation
Australia
India
Israel
Slovakia
Canada
Hungary
Germany
Bulgaria
Denmark
Greece
Latvia
Estonia
Finland
Korea, Republic of
France
Netherlands

summary: This was a randomized, double-blind, active controlled, multicenter, parallel-group study evaluating secukinumab monotherapy and adalimumab monotherapy in approximately 850 patients with active psoriatic arthritis (PsA) who are naïve to biologic therapy and are intolerant or having inadequate response to conventional disease modifying anti-rheumatic drugs (also known as non-biologic DMARDs).


title: A Multicenter, International, Open-label, Safety Study of ND0612, a Solution of Levodopa/Carbidopa Delivered Via a Pump System as a Continuous Subcutaneous Infusion in Subjects With Advanced Parkinson's Disease

summary: This is a multi-center, international, open-label, safety study of ND0612, a solution of levodopa/carbidopa (LD/CD) delivered via a pump system as a continuous SC infusion in subjects with advanced Parkinson's Disease.

lead_sponsor: NeuroDerm Ltd.

location_country:
Poland
Spain
Italy
Austria
United States
France
Israel
Germany
Czechia

location_facility: University of Florida Health at Jacksonville

location_facility: Hadassah Medical Center, Ein-Kerem Campus

location_facility: Krakowska Akademia Neurologii Sp. z o.o.

location_facility: Parkinson's Disease and Movement Disorder Center of Boca Raton

location_facility: Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

location_facility: Parkinsons Disease Treatment Center of Southwest Florida

location_facility: Rocky Mountain Movement Disorders Center

location_facility: The Parkinsons and Movement Disorder Institute

location_facility: USF Health Parkinson's Disease and Movement Disorders

location_facility: Indywidualna Praktyka Lekarska prof. dr hab

location_facility: The Movement Disorder Clinic of Oklahoma


title: A Phase 1 Dose Escalation and Cohort Expansion Study of TSR-042, an Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors

acronym: GARNET

summary: This is a multi-center, open-label, first-in-human Phase 1 study evaluating the anti-programmed death receptor 1 (anti-PD-1) antibody dostarlimab (also known as TSR-042) n participants with advanced solid tumors who have limited available treatment options. The study will be conducted in 2 parts with Part 1 consisting of safety evaluation, pharmacokinetics (PK), and pharmacodynamics (PDy) of escalating doses of dostarlimab. Dose escalation will be based on ascending weight-based dose levels (DLs) of dostarlimab and will continue until the maximum tolerated dose (MTD) is reached or may be stopped at any dose level up to the highest dose of 20 milligrams per kilograms (mg/kg) based on emerging safety and PK/PDy data. Part 2 will be conducted in two subparts, Part 2A (fixed-dose safety evaluation cohorts) and Part 2B (expansion cohorts). Part 2A of the study will evaluate the safety and tolerability of dostarlimab at fixed doses of 500 mg administered every 3 weeks (Q3W) and 1000 mg administered every 6 weeks (Q6W). Part 2B of the study will examine the safety and clinical activity of dostarlimab in cohorts of participants with specific types of advanced solid tumors.

ReferenceCitation: Patnaik A, Weiss GJ, Rasco DW, Blaydorn L, Mirabella A, Beeram M, Guo W, Lu S, Danaee H, McEachern K, Im E, Sachdev JC. Safety, antitumor activity, and pharmacokinetics of dostarlimab, an anti-PD-1, in patients with advanced solid tumors: a dose-escalation phase 1 trial. Cancer Chemother Pharmacol. 2022 Jan;89(1):93-103. doi: 10.1007/s00280-021-04358-3. Epub 2021 Nov 8.

ReferenceCitation: Zhang XT, Chen H, Shao W, Zhongping JL, Melham M, Lu S.A Competitive Ligand Binding Assay to Measure Antidrug Antibodies Against Dostarlimab (TSR-042).2021; DOI: 10.1186/s41120-021-00039-w

doi: zhang

ReferenceCitation: Patterson M, Beausang LA, Rup B, Bowsher R, Krug K, Gunn G, Melham M, Lu S.A Bridging Assay for Detection and Characterization of Anti-Drug Antibodies to Dostarlimab, a New Anti-PD-1 Therapeutic Monoclonal Antibody .2021;7(11) DOI: DOI 10.1186/s41120-021-00045-y

doi: patterson

ReferenceCitation: Kumar S, Ghosh S, Sharma G, Wang Z, Kehry MR, Marino MH, Neben TY, Lu S, Luo S, Roberts S, Ramaswamy S, Danaee H, Jenkins D. Preclinical characterization of dostarlimab, a therapeutic anti-PD-1 antibody with potent activity to enhance immune function in in vitro cellular assays and in vivo animal models. MAbs. 2021 Jan-Dec;13(1):1954136. doi: 10.1080/19420862.2021.1954136.

ReferenceCitation: Oaknin A, Gilbert L, Tinker AV, Brown J, Mathews C, Press J, Sabatier R, O'Malley DM, Samouelian V, Boni V, Duska L, Ghamande S, Ghatage P, Kristeleit R, Leath C III, Guo W, Im E, Zildjian S, Han X, Duan T, Veneris J, Pothuri B. Safety and antitumor activity of dostarlimab in patients with advanced or recurrent DNA mismatch repair deficient/microsatellite instability-high (dMMR/MSI-H) or proficient/stable (MMRp/MSS) endometrial cancer: interim results from GARNET-a phase I, single-arm study. J Immunother Cancer. 2022 Jan;10(1). pii: e003777. doi: 10.1136/jitc-2021-003777.

ReferenceCitation: Kristeleit R, Mathews C, Redondo A, Boklage S, Hanlon J, Im E, Brown J. Patient-reported outcomes in the GARNET trial in patients with advanced or recurrent mismatch repair-deficient/microsatellite instability-high endometrial cancer treated with dostarlimab. Int J Gynecol Cancer. 2022 Aug 16. pii: ijgc-2022-003492. doi: 10.1136/ijgc-2022-003492. [Epub ahead of print]

ReferenceCitation: Moreno V, Roda D, Pikiel J, Trigo J, Bosch-Barrera J, Drew Y, Kristeleit R, Hiret S, Bajor DL, Cruz P, Beck JT, Ghosh S, Dabrowski C, Antony G, Duan T, Veneris J, Zografos E, Subramanian J. Safety and Efficacy of Dostarlimab in Patients With Recurrent/Advanced Non-small Cell Lung Cancer: Results from Cohort E of the Phase I GARNET Trial. Clin Lung Cancer. 2022 Nov;23(7):e415-e427. doi: 10.1016/j.cllc.2022.05.013. Epub 2022 May 23.

ReferenceCitation: Oaknin A, Tinker AV, Gilbert L, Samouëlian V, Mathews C, Brown J, Barretina-Ginesta MP, Moreno V, Gravina A, Abdeddaim C, Banerjee S, Guo W, Danaee H, Im E, Sabatier R. Clinical activity and safety of the anti-PD-1 monoclonal antibody dostarlimab for patients with recurrent or advanced dMMR endometrial cancer. Future Oncol. 2021 Oct 1;17(29):3781-3785. doi: 10.2217/fon-2021-0598. Epub 2021 Aug 24.

ReferenceCitation: Oaknin A, Tinker AV, Gilbert L, Samouëlian V, Mathews C, Brown J, Barretina-Ginesta MP, Moreno V, Gravina A, Abdeddaim C, Banerjee S, Guo W, Danaee H, Im E, Sabatier R. Clinical Activity and Safety of the Anti-Programmed Death 1 Monoclonal Antibody Dostarlimab for Patients With Recurrent or Advanced Mismatch Repair-Deficient Endometrial Cancer: A Nonrandomized Phase 1 Clinical Trial. JAMA Oncol. 2020 Nov 1;6(11):1766-1772. doi: 10.1001/jamaoncol.2020.4515.

ipd_sharing_description: IPD for this study will be made available via the Clinical Study Data Request site.

lead_sponsor: Tesaro, Inc.

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Canada
United States
France
Czechia


title: A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF THE SUBCUTANEOUS ADMINISTRATION OF TANEZUMAB IN SUBJECTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE

summary:
Tanezumab is a monoclonal antibody that binds to and inhibits the actions of nerve growth factor (NGF). The Nerve Growth Factor Inhibitor (NGFI) class may offer an important breakthrough in the treatment of chronic pain and is under clinical investigation for the treatment of pain associated with osteoarthritis or other chronic pain conditions.

The primary objective of this study is to demonstrate superior efficacy of tanezumab 5 mg and 2.5 mg administered subcutaneously (SC) every 8 weeks versus placebo at Week 24 in subjects with osteoarthritis of the knee or hip. The 2.5 mg dose was shown to provide efficacy benefits with a favorable safety profile when administered intravenously in previous Phase 3 clinical trials. The 5 mg dose is expected to provide added efficacy benefit over the 2.5 mg dose based on data from previous studies.

ReferenceCitation: Atkinson J, Edwards RA, Bonfanti G, Barroso J, Schnitzer TJ. A Two-Step, Trajectory-Focused, Analytics Approach to Attempt Prediction of Analgesic Response in Patients with Moderate-to-Severe Osteoarthritis. Adv Ther. 2022 Oct 27. doi: 10.1007/s12325-022-02336-6. Online ahead of print.

ReferenceCitation: Mease P, Kuritzky L, Wright WL, Mallick-Searle T, Fountaine R, Yang R, Sadrarhami M, Faison W, Johnston E, Viktrup L. Efficacy and safety of tanezumab, NSAIDs, and placebo in patients with moderate to severe hip or knee osteoarthritis and a history of depression, anxiety, or insomnia: post-hoc analysis of phase 3 trials. Curr Med Res Opin. 2022 Aug 28:1-14. doi: 10.1080/03007995.2022.2113689. [Epub ahead of print]

ReferenceCitation: Schnitzer TJ, Bonfanti G, Atkinson J, Donevan S, Viktrup L, Barroso J, Whalen E, Edwards RA. Characterizing 16-Week Responder Profiles Using Group-Based Trajectory Modeling in Over 4300 Clinical Trial Participants Receiving Pharmaceutical Treatment for Moderate to Severe Osteoarthritis. Adv Ther. 2022 Oct;39(10):4742-4756. doi: 10.1007/s12325-022-02290-3. Epub 2022 Aug 12.

ReferenceCitation: Conaghan PG, Dworkin RH, Schnitzer TJ, Berenbaum F, Bushmakin AG, Cappelleri JC, Viktrup L, Abraham L. WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee. J Rheumatol. 2022 Jun;49(6):615-621. doi: 10.3899/jrheum.210543. Epub 2022 Mar 1.

ReferenceCitation: Conaghan PG, Abraham L, Viktrup L, Cislo P. Impact of tanezumab on health status, non-work activities and work productivity in adults with moderate-to-severe osteoarthritis. BMC Musculoskelet Disord. 2022 Feb 1;23(1):106. doi: 10.1186/s12891-022-05029-x.

ReferenceCitation: Berenbaum F, Schnitzer T, Kivitz A, Viktrup L, Johnston E, Yang R, Whalen E, Tive L, Semel D. Gender, age, disease severity, body mass index and diabetes may not affect response to subcutaneous tanezumab in patients with osteoarthritis after 16 weeks of treatment. A subgroup analysis of placebo-controlled trials. Int J Clin Pract. 2021 Dec;75(12):e14975. doi: 10.1111/ijcp.14975. Epub 2021 Oct 21.

ReferenceCitation: Berenbaum F, Schnitzer TJ, Kivitz AJ, Viktrup L, Hickman A, Pixton G, Brown MT, Davignon I, West CR. General Safety and Tolerability of Subcutaneous Tanezumab for Osteoarthritis: A Pooled Analysis of Three Randomized, Placebo-Controlled Trials. Arthritis Care Res (Hoboken). 2022 Jun;74(6):918-928. doi: 10.1002/acr.24637. Epub 2022 Mar 25.

ReferenceCitation: Berenbaum F, Langford R, Perrot S, Miki K, Blanco FJ, Yamabe T, Isogawa N, Junor R, Carey W, Viktrup L, West CR, Brown MT, Verburg KM. Subcutaneous tanezumab for osteoarthritis: Is the early improvement in pain and function meaningful and sustained? Eur J Pain. 2021 Aug;25(7):1525-1539. doi: 10.1002/ejp.1764. Epub 2021 May 3.

ReferenceCitation: Berenbaum F, Blanco FJ, Guermazi A, Miki K, Yamabe T, Viktrup L, Junor R, Carey W, Brown MT, West CR, Verburg KM. Subcutaneous tanezumab for osteoarthritis of the hip or knee: efficacy and safety results from a 24-week randomised phase III study with a 24-week follow-up period. Ann Rheum Dis. 2020 Jun;79(6):800-810. doi: 10.1136/annrheumdis-2019-216296. Epub 2020 Mar 31.

location_country:
Poland
Portugal
Spain
Italy
Austria
United Kingdom
Finland
Sweden
Hungary
France
Romania
Japan
Germany
Bulgaria
Slovakia

location_facility: National Hospital Organization Utsunomiya national Hospital

location_facility: CTC (Clinical Trial Center), Sahlgrenska University Hospital

location_facility: National Hospital Organization Sagamihara National Hospital

location_facility: Corporació Sanitaria Parc Taulí de Sabadell

location_facility: Rheumazentrum Prof. Dr. med Gunther Neeck

location_facility: Centrum Kliniczno - Badawcze J. Brzezicki, B. Gornikiewicz - Brzezicka Lekarze Spolka Partnerska

location_facility: Multiprofile hospital for active treatment - "Lyulin" EAD

location_facility: National Hospital Organization Osaka Minami Medical Center

location_facility: AZ OSPEDALIERO - UNIVERSITARIA CAREGGI-SOD Reumatologia - Dip. Medicina Sperimentale e Clinica

location_facility: Centro Hospitalar Lisboa Ocidental, E.P.E., Hospital Egas Moniz

location_facility: Bekes Megyei Központi Korhaz Dr Rethy Pal Tagkorhaz, Reumatologia Szakrendeles

location_facility: Spitalul Clinic Judetean de Urgenta Sf. Apostol Andrei Constanta

location_facility: Unite Clinique Therapeutique des Maladies Osteoarticulaires

location_facility: U.O.C. Farmacia - Gestione medicinali per la sperimentazione clinica

location_facility: Complejo Hospital Universitario A Coruna (CHUAC)

location_facility: Centrum Terapii Wspolczesnej J.M Jasnorzewska

location_facility: Clinical Trials, Bradford on Avon Health Centre

location_facility: Istituto Clinico Humanitas Unita Operativa di Medicina Generale e Reumatologia -

location_facility: Spitalul Clinic Judetean de Urgenta Sibiu

location_facility: Kitasato University Kitasato Institute Hospital

location_facility: Avdelningen for kliniska provningar, S-huset

location_facility: St George's University Hospitals NHS Foundation Trust

location_facility: Medical Corporation Association Sankikai, Yokohama Shinmidori General Hospital

location_facility: Farmacia AOUC Settore Sperimentazione Farmaci

location_facility: Multiprofile Hospital for Active Treatment-Silistra AD

location_facility: Hospital General Universitario de Guadalajara

location_facility: Sonodakai Joint Replacement Center Hospital

location_facility: Hospital Universitario La Princesa Farmacia - Ensayos Clinicos

location_facility: Corporacio Sanitaria Parc Tauli de Sabadell

location_facility: Azienda Ospedaliera Universitaria Senese - UOC Reumatologia,

location_facility: NZOZ OSTEO-MEDIC s.c. A. Racewicz, J. Supronik

location_facility: National Hospital Organization Nagasaki Medical Center

location_facility: Health Centre, Bradford on Avon & Melksham Health Partnership

location_facility: Oxford University Hospitals NHS Foundation Trust

location_facility: Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

location_facility: Multiprofile Hospital for active treatment "SVETA PETKA" AD

location_facility: NMTH 'Tsar Boris III". Clinic of Internal Diseases

location_facility: Diagnostic Consultative Center XIV- Sofia EOOD

location_facility: Hospital Regional Universitario de Malaga. Farmacia del Hospital Civil

location_facility: Hospital Universitario La Paz Servicio de Farmacia

location_facility: AOU Maggiore della Carita di Novara - S.C. Medicina Fisica e Riabilitativa

location_facility: Tolna Megyei Balassa Janos Korhaz, Ortopediai osztaly

location_facility: Northumbria Healthcare NHS Foundation Trust

location_facility: Azienda Ospedaliero-Universitaria E Policlinico Umberto I

location_facility: Hospital Universitario Marqués de Valdecilla


acronym: SELECT-BEYOND

title: A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib (ABT-494) to Placebo on Stable Conventional Synthetic Disease-Modifying Anti-Rheumatic Drugs (csDMARDs) in Subjects With Moderately to Severely Active Rheumatoid Arthritis With Inadequate Response or Intolerance to Biologic DMARDs (bDMARDs)

lead_sponsor: AbbVie

ReferenceCitation: Genovese MC, Fleischmann R, Combe B, Hall S, Rubbert-Roth A, Zhang Y, Zhou Y, Mohamed MF, Meerwein S, Pangan AL. Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2513-2524. doi: 10.1016/S0140-6736(18)31116-4. Epub 2018 Jun 18.

ReferenceCitation: Bergman M, Buch MH, Tanaka Y, Citera G, Bahlas S, Wong E, Song Y, Zueger P, Ali M, Strand V. Routine Assessment of Patient Index Data 3 (RAPID3) in Patients with Rheumatoid Arthritis Treated with Long-Term Upadacitinib Therapy in Five Randomized Controlled Trials. Rheumatol Ther. 2022 Dec;9(6):1517-1529. doi: 10.1007/s40744-022-00483-4. Epub 2022 Sep 20.

ReferenceCitation: Yamaoka K, Tanaka Y, Kameda H, Khan N, Sasaki N, Harigai M, Song Y, Zhang Y, Takeuchi T. The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. Drug Saf. 2021 Jun;44(6):711-722. doi: 10.1007/s40264-021-01067-x. Epub 2021 May 27.

ReferenceCitation: Cohen SB, van Vollenhoven RF, Winthrop KL, Zerbini CAF, Tanaka Y, Bessette L, Zhang Y, Khan N, Hendrickson B, Enejosa JV, Burmester GR. Safety profile of upadacitinib in rheumatoid arthritis: integrated analysis from the SELECT phase III clinical programme. Ann Rheum Dis. 2021 Mar;80(3):304-311. doi: 10.1136/annrheumdis-2020-218510. Epub 2020 Oct 28. Erratum in: Ann Rheum Dis. 2021 May;80(5):e83.

ReferenceCitation: Strand V, Schiff M, Tundia N, Friedman A, Meerwein S, Pangan A, Ganguli A, Fuldeore M, Song Y, Pope J. Effects of upadacitinib on patient-reported outcomes: results from SELECT-BEYOND, a phase 3 randomized trial in patients with rheumatoid arthritis and inadequate responses to biologic disease-modifying antirheumatic drugs. Arthritis Res Ther. 2019 Dec 2;21(1):263. doi: 10.1186/s13075-019-2059-8.

ReferenceCitation: Nader A, Mohamed MF, Winzenborg I, Doelger E, Noertersheuser P, Pangan AL, Othman AA. Exposure-Response Analyses of Upadacitinib Efficacy and Safety in Phase II and III Studies to Support Benefit-Risk Assessment in Rheumatoid Arthritis. Clin Pharmacol Ther. 2020 Apr;107(4):994-1003. doi: 10.1002/cpt.1671. Epub 2019 Nov 30.

ipd_sharing_description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.

location_country:
Spain
United Kingdom
United States
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Puerto Rico
Israel
Turkey
Sweden
Slovakia
Canada
Switzerland
Hungary
Germany
Greece
Ireland
Estonia
Latvia
Finland
New Zealand
Korea, Republic of
France

location_facility: Pacific Arthritis Ctr Med Grp /ID# 142783

location_facility: Vital Medical Center Orvosi es /ID# 142586

location_facility: East Penn Rheumatology Assoc /ID# 142790

location_facility: P. Stradins Clinical Univ Hosp /ID# 142623

location_facility: Houston Institute for Clin Res /ID# 142768

location_facility: Mid Essex Hospitals NHS Trust /ID# 148992

location_facility: Clinical Research Ctr Reading /ID# 151714

location_facility: Rheumatology Ctr of San Diego /ID# 153576

location_facility: Hospital Clin Univ San Carlos /ID# 142711

location_facility: AZ Arthritis and Rheum Researc /ID# 146075

location_facility: Joint & Muscle Research Instit /ID# 142797

location_facility: Comple Hosp Univ de A Coruna /ID# 142708

location_facility: Ankara Ataturk Training & Res /ID# 142727

location_facility: St. Joseph Heritage Healthcare /ID# 149273

location_facility: Trinity Universal Research Association /ID# 149278

location_facility: Clinical Pharmacology Study Gr /ID# 142744

location_facility: Inland Rheum Clin Trials Inc. /ID# 142787

location_facility: Family Outpatient clinic#4,LLC /ID# 150910

location_facility: Bekes Megyei Pandy Kalman Korh /ID# 142588

location_facility: Seoul National University Hospital /ID# 142622

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz /ID# 142587

location_facility: Clayton Medical Associates dba Saint Louis Rheumatology /ID# 142745

location_facility: West Tennessee Research Inst /ID# 142739

location_facility: Arthritis & Osteo Ctr of S. TX /ID# 142773

location_facility: Medallion Clinical Research Institute, LLC /ID# 142740

location_facility: Wilhelminenspital der Stadt Wien /ID# 142422

location_facility: Centrum Medyczne Pratia Warszawa /ID# 142667

location_facility: Coastal Carolina Health Care /ID# 148351

location_facility: Centre Hospitalier Jean Rougie /ID# 142556

location_facility: University of California, Los Angeles /ID# 148348

location_facility: Ondokuz mayis University Facul /ID# 142728

location_facility: Dartmouth-Hitchcock Medical Center /ID# 145958

location_facility: Aurora Rheumatology and Immunotherapy Center /ID# 142820

location_facility: Jefrey D. Lieberman, MD, P.C. /ID# 151713

location_facility: St. Anthony Comprehsve Res Ins /ID# 148349

location_facility: Narodny ustav reumatickych chorob Piestany /ID# 142691

location_facility: St Vincent's University Hosp /ID# 142593

location_facility: LMU Klinikum der Universität München /ID# 142564

location_facility: CHR Orleans - Hopital de la Source /ID# 142557

location_facility: AZ Arthritis & Rheum Research /ID# 156090

location_facility: Rheuma Zentrum Favoriten GmbH /ID# 142421

location_facility: Rheumatology Clinic of Houston /ID# 150915

location_facility: Hospital Universitario La Fe /ID# 142716

location_facility: Diagnostic Group Integrated He /ID# 148340

location_facility: AZ Arthritis and Rheum Assoc /ID# 148593

location_facility: Arth and Osteo Clin Brazo Valley /ID# 148343

location_facility: Arthritis Clinic of Central TX /ID# 148346

location_facility: CHU Bordeaux-Hopital Pellegrin /ID# 144700

location_facility: The Arthritis & Diabetes Clinic, Inc. /ID# 142793

location_facility: Hanyang University Seoul Hospi /ID# 150883

location_facility: Centrum Medyczne Pratia Gdynia /ID# 142666

location_facility: Charité Universitätsmedizin Campus Mitte /ID# 142559

location_facility: Orebro Universitetssjukhuset /ID# 142718

location_facility: Centrum Medyczne AMED Warszawa Targowek /ID# 142663

location_facility: Rheum Assoc of North Alabama /ID# 145959

location_facility: Arthritis & Osteo Medical Ctr /ID# 142770

location_facility: Deerbrook Medical Associates /ID# 151712

location_facility: Healthcare Research Consultant /ID# 142815

location_facility: East Tallinn Central Hospital /ID# 142543

location_facility: AZ Arthritis and Rheum Researc /ID# 142816

location_facility: TriWest Research Associates- La Mesa /ID# 142792

location_facility: North Shore University Hospital /ID# 142772

location_facility: Schoen Klinikum Hamburg Eilbek /ID# 142566

location_facility: Clinical Investigation Special /ID# 149270

location_facility: Medizinische Universität Wien /ID# 142424

location_facility: Cliniques Universitaires Saint Luc /ID# 142426

location_facility: The Queen Elizabeth Hospital /ID# 142419

location_facility: Universitaetsklinik fuer Inner /ID# 142423

location_facility: Centro Hospitalar De Vila Nova /ID# 142670

location_facility: Rheumatic Disease Clin Res Ctr /ID# 150914

location_facility: Cincinnati Rheumatic Disease Study Group, Inc. /ID# 142791

location_facility: WroMedica I. Bielicka, A. Strzalkowska s.c. /ID# 142665

location_facility: AZ Arthritis and Rheum Researc /ID# 148592

location_facility: Stanford University School of Med /ID# 142761

location_facility: Trinity Health Med Arts Clinic /ID# 142754

location_facility: Paijat-Hame Central Hospital /ID# 149185

location_facility: The Vancouver Clinic, INC. PS /ID# 147946

location_facility: New England Research Associates, LLC /ID# 142763

location_facility: Hopital Universitaire Purpan /ID# 144697

location_facility: Vanguard Medical Research, LLC /ID# 153123

location_facility: North Mississippi Med Clinics /ID# 142781

location_facility: Revmatologie MUDr. Klara Sirova /ID# 142536

location_facility: Tel Aviv Sourasky Medical Ctr /ID# 142597

location_facility: Arthritis Research of Florida /ID# 142811

location_facility: Centro Hospitalar Lisboa Norte, EPE /ID# 142668

location_facility: Lovelace Scientific Resources /ID# 142779

location_facility: H. Un. Marques de Valdecilla /ID# 142706

location_facility: Arizona Research Center, Inc. /ID# 142741

location_facility: St. Luke's Clinic - Rheumatolo /ID# 150923

location_facility: Arthritis Care and Diagnostic /ID# 151344

location_facility: The Center for Rheumatology & /ID# 142742

location_facility: HFR Fribourg - Hopital Canton /ID# 142723

location_facility: Hacettepe University Medical Faculty /ID# 142729

location_facility: General Hospital of Athens Laiko /ID# 142579

location_facility: Western Washington Arthritis C /ID# 142776

location_facility: Pioneer Research Solutions, Inc. /ID# 151346

location_facility: Revita Reumatologiai Rendelo /ID# 142590

location_facility: Arthritis & Osteoporosis Assoc /ID# 147567

location_facility: Arthritis & Osteoporosis Clinic /ID# 142760

location_facility: Timaru Medical Specialists Ltd /ID# 142657

summary:
The study objective of Period 1 (Day 1 to Week 24) is to compare the safety and efficacy of 30 mg once daily (QD) and 15 mg QD upadacitinib versus placebo for the treatment of signs and symptoms of participants with moderately to severely active RA who were on a stable dose of csDMARDs and had an inadequate response to or intolerance to at least 1 bDMARD.

The study objective of Period 2 (Week 24 to Week 260) is to evaluate the long-term safety, tolerability, and efficacy of upadacitinib 15 mg QD and 30 mg QD in participants with RA who completed Period 1.


title: A Phase 3, Prospective, Randomized, Double-blind, Multi-center Study of the Efficacy and Safety of Lanreotide Autogel®/Depot 120 mg Plus BSC vs. Placebo Plus BSC for Tumour Control in Subjects With Well Differentiated, Metastatic and/or Unresectable, Typical or Atypical, Lung Neuroendocrine Tumours

acronym: SPINET

summary:
This is a Phase 3, prospective, multi-center, randomized, double-blind, study evaluating the efficacy and safety of LAN plus BSC versus placebo plus BSC for the treatment of well-differentiated, metastatic and/or unresectable, typical or atypical bronchopulmonary NETs.

This study contains two phases: the Double-Blind (DB) Phase, and the Open Label (OL) Phase. The DB Phase includes: Screening, Baseline and Treatment period. The OL Phase will consist of two periods: Treatment Period and Follow-Up Period.

The primary objective will be to describe the antitumour efficacy of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) every 28 days, in terms of progression-free survival (PFS), measured by central review using Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 criteria, every 12 weeks, in subjects randomized to LAN with unresectable and/or metastatic well differentiated, typical or atypical bronchopulmonary neuroendocrine tumours.

Recent updates of National Cancer Institute Cancer Network (NCCN) & European Neuroendocrine Tumor Society (ENETS) guidelines recommend SSA in first line for the treatment of locoregional unresectable or metastatic bronchopulmonary NETs as an option beyond 'observation' leading to slow and difficult recruitment in SPINET study. Consequently, it was decided to prematurely stop the recruitment in the SPINET study and to transition all subjects still treated in the double-blind phase to the open label (OL) treatment and follow-up phases following respective country approvals of Amendment #5.

The new aim of this Phase 3, multicenter, prospective, randomized placebo-controlled clinical study is to describe the antitumor efficacy and safety of Lanreotide Autogel/Depot 120 mg (LAN) plus Best Supportive Care (BSC) in subjects with well-differentiated, metastatic and/or unresectable, typical or atypical, bronchopulmonary NETs.

lead_sponsor: Ipsen

location_country:
Denmark
Poland
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
United States
France
Germany

location_facility: Azienda Ospedaliera Universitaria di Perugia Santa Maria della Misericordia

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Institut du Cancer de Montpellier (ICM) Val d'Aurelle

location_facility: University Center of Ophtalmology & Oncology

location_facility: Szpital Kliniczny im. H. Święcickiego U.M.

location_facility: Insituti Scientifico Romagnolo per lo Studio e la cura dei Tumori (IRST)

location_facility: Johann Wolfgang Goethe-Universitätsklinikum Frankfurt

location_facility: Zakladu Medycyny Nuklearne i Endokrynologii Onkologicznej

location_facility: AKH und Med. University Vienna Allg Krankenhaus Wien

location_facility: Centre René Gauducheau ICO institut de Cancerologie de l'Ouest


title: Phase 3, Randomized, Open-label, Active-controlled Study Evaluating the Efficacy and Safety of Oral Vadadustat for the Maintenance Treatment of Anemia in Subjects With Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD) (PRO2TECT-CONVERSION)

summary: A multicenter, randomized, open-label, active-controlled Phase 3 study for the maintenance treatment of anemia in participants with Non-dialysis-dependent Chronic Kidney Disease (NDD-CKD)

ReferenceCitation: Natale P, Palmer SC, Jaure A, Hodson EM, Ruospo M, Cooper TE, Hahn D, Saglimbene VM, Craig JC, Strippoli GF. Hypoxia-inducible factor stabilisers for the anaemia of chronic kidney disease. Cochrane Database Syst Rev. 2022 Aug 25;8:CD013751. doi: 10.1002/14651858.CD013751.pub2. Review.

ReferenceCitation: Chertow GM, Pergola PE, Farag YMK, Agarwal R, Arnold S, Bako G, Block GA, Burke S, Castillo FP, Jardine AG, Khawaja Z, Koury MJ, Lewis EF, Lin T, Luo W, Maroni BJ, Matsushita K, McCullough PA, Parfrey PS, Roy-Chaudhury P, Sarnak MJ, Sharma A, Spinowitz B, Tseng C, Tumlin J, Vargo DL, Walters KA, Winkelmayer WC, Wittes J, Eckardt KU; PRO2TECT Study Group. Vadadustat in Patients with Anemia and Non-Dialysis-Dependent CKD. N Engl J Med. 2021 Apr 29;384(17):1589-1600. doi: 10.1056/NEJMoa2035938.

lead_sponsor: Akebia Therapeutics

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
South Africa
Czechia
Poland
Austria
Australia
Russian Federation
Argentina
Puerto Rico
Israel
Turkey
Mexico
Malaysia
Slovakia
Brazil
Canada
Hungary
Germany
Bulgaria
New Zealand
Korea, Republic of
France
Chile
Colombia

location_facility:
Research Site #2
Research Site #1
Research Site
Research Site #3


title: Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement A Controlled Randomized Trial in the Surgical Treatment of Aortic Valve Disease

acronym: PERSIST-AVR

summary:
Prospective, randomized, stratified non blinded multi-center, international, post market trial assessed in a non-inferiority study.

The trial has a flexible sample size that will be determined adaptively. The trial will enroll up to 1234 subjects, but accrual may stop earlier at approximately 900 or 1050 subjects These subjects will be enrolled at approximately 60 worldwide investigational sites where the device is commercially available The primary objective of this trial is to test the safety and efficacy of Perceval versus standard sutured stented bioprosthetic aortic valves among the intended trial population.

ReferenceCitation: Lorusso R, Folliguet T, Shrestha M, Meuris B, Kappetein AP, Roselli E, Klersy C, Nozza M, Verhees L, Larracas C, Goisis G, Fischlein T. Sutureless versus Stented Bioprostheses for Aortic Valve Replacement: The Randomized PERSIST-AVR Study Design. Thorac Cardiovasc Surg. 2020 Mar;68(2):114-123. doi: 10.1055/s-0038-1675847. Epub 2018 Nov 29.

ReferenceCitation: Fischlein T, Folliguet T, Meuris B, Shrestha ML, Roselli EE, McGlothlin A, Kappert U, Pfeiffer S, Corbi P, Lorusso R; Perceval Sutureless Implant Versus Standard-Aortic Valve Replacement Investigators. Sutureless versus conventional bioprostheses for aortic valve replacement in severe symptomatic aortic valve stenosis. J Thorac Cardiovasc Surg. 2021 Mar;161(3):920-932. doi: 10.1016/j.jtcvs.2020.11.162. Epub 2020 Dec 14.

ReferenceCitation: Lorusso R, Ravaux JM, Pollari F, Folliguet TA, Kappert U, Meuris B, Shrestha ML, Roselli EE, Bonaros N, Fabre O, Corbi P, Troise G, Andreas M, Pinaud F, Pfeiffer S, Kueri S, Tan E, Voisine P, Girdauskas E, Rega F, Garcia-Puente J, Fischlein T; on behalf the PERSIST-AVR Investigators. Pacemaker implantation after sutureless or stented valve: results from a controlled randomized trial. Eur J Cardiothorac Surg. 2022 Sep 2;62(4). pii: ezac164. doi: 10.1093/ejcts/ezac164.

ReferenceCitation: Lorusso R, Jiritano F, Roselli E, Shrestha M, Folliguet T, Meuris B, Pollari F, Fischlein T; PERSIST-AVR Investigators. Perioperative platelet reduction after sutureless or stented valve implantation: results from the PERSIST-AVR controlled randomized trial. Eur J Cardiothorac Surg. 2021 Dec 1;60(6):1359-1365. doi: 10.1093/ejcts/ezab175.

lead_sponsor: Corcym S.r.l

location_country:
Spain
Italy
Austria
Netherlands
United Kingdom
Canada
United States
Chile
France
Israel
Belgium
Germany

location_facility: Hospital Clinico Universitario Virgen De La Arrixaca

location_facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval

location_facility: Houston Methodist Research Institute, Houston Methodist Hospital

location_facility: Fondazione Poliambulanza Istituto Ospedaliero

location_facility: Herzzentrum Dresden GmbH Universitätsklinik

location_facility: Fondazione Toscana Gabriele Monasterio-Presidio Ospedaliero di Massa

location_facility: lstituto Clinico Sant'Ambrogio e San Siro

location_facility: Hospital University Germans Trias I Pujol

location_facility: Complejo Hospitalario Universitario De A Coruña

location_facility: Heart and Vascular Institute, Cleveland Clinic

intervention_type: Device


acronym: CREAD

title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy And Safety Study of Crenezumab in Patients With Prodromal to Mild Alzheimer's Disease.

ReferenceCitation: Ostrowitzki S, Bittner T, Sink KM, Mackey H, Rabe C, Honig LS, Cassetta E, Woodward M, Boada M, van Dyck CH, Grimmer T, Selkoe DJ, Schneider A, Blondeau K, Hu N, Quartino A, Clayton D, Dolton M, Dang Y, Ostaszewski B, Sanabria-Bohórquez SM, Rabbia M, Toth B, Eichenlaub U, Smith J, Honigberg LA, Doody RS. Evaluating the Safety and Efficacy of Crenezumab vs Placebo in Adults With Early Alzheimer Disease: Two Phase 3 Randomized Placebo-Controlled Trials. JAMA Neurol. 2022 Sep 19. doi: 10.1001/jamaneurol.2022.2909. [Epub ahead of print]

location_country:
Croatia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Costa Rica
Belgium
Japan
Czechia
Poland
Hong Kong
Portugal
Slovenia
Austria
Australia
Russian Federation
Turkey
Mexico
Sweden
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Finland
Korea, Republic of
France

location_facility: The Cognitive and Research Center of New Jersey

location_facility: Ospedale Casati Passirana di Rho; Centro Regionale Alzheimer

location_facility: ICIMED Instituto de Investigación en Ciencias Médicas

location_facility: Albany Medical Faculty Physicians COmmunity Division. The Neurology Group

location_facility: National Clinical Research Inc.-Richmond

location_facility: State autonomous institution of healthcare Inter-regional clinical and diagnostic center

location_facility: Sahlgrenska Academy University,Neuroscience and Physiology;Departmt of Psychiatry and Neurochemistry

location_facility: Hospital Mutua De Terrasa; Servicio de Neurologia

location_facility: Alzheimer's Research and Treatment Center

location_facility: Surrey and Borders NHS Foundation Trust; Brain Science Research Unit

location_facility: Advanced Memory Research Institute of NJ

location_facility: Servicio de Neurología Hospital Viamed Montecanal.

location_facility: Ospedale S. Maria Nascente; Fondazione Don Gnocchi; Dip. Neurologia Riabilitativa

location_facility: SHI City Psychoneurological Dispensary #7

location_facility: Jávorszky Ödön Kórház, Neurológia és stroke osztály

location_facility: Prince of Wales Hospital; Dept. of Medicine & Therapeutics

location_facility: Russian Medical Military Academy n.a. S.M.Kirov; Neurology Department

location_facility: Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie

location_facility: Coventry and Warwickshire Partnership NHS Trust

location_facility: Hospital Beatriz Angelo; Servico de Neurologia

location_facility: Universitätsklinikum Ulm; Klinik für Neurologie

location_facility: Aarhus Universitetshospital, Neurologisk Afdeling F, Demensklinikken

location_facility: General Teaching Hospital, Departmetn of Neurology

location_facility: Hospital Sant Joan de Deu; Servicio de Neurología

location_facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

location_facility: Szent Borbala Korhaz; Neurologiai es Stroke Osztaly

location_facility: Kawartha Centre - Redefining Healthy Aging

location_facility: Universitätsklinikum Rostock Zentrum für Nervenheilkunde

location_facility: Hospital Universitario de Burgos. Servicio de Neurología

location_facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia

location_facility: National Center of Neurology and Psychiatry

location_facility: Hospital Universitario la Fe; Servicio de Neurologia

location_facility: NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

location_facility: Complejo Asistencial Universitario de Salamanca; Servicio de Psiquiatría

location_facility: Konventhospital Barmherzige Brüder; Neurologie I

location_facility: Clinica Ruber, 4 planta; Servicio de Neurologia

location_facility: Universitario de La Princesa; Servicio de Neurología

location_facility: Regional mental hospital; Department of psychiatry, psychology and sexology

location_facility: City Clinical Hospital # 2 n.a. V.I. Razumovsky

location_facility: Hospital Vall d'Hebron; Servicio de Neurología

location_facility: ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine

location_facility: Istanbul University Istanbul School of Medicine; Neurology

location_facility: Institute for Neurodegenerative Disorders

location_facility: National Hospital Organization Matsumoto Medical Center

location_facility: Hospital General Universitario de Albacete; Servicio de Neurología

location_facility: University of North Texas Health Science Center; Fort Worth Patient Care Center

location_facility: Alliance for Wellness, dba Alliance for Research

location_facility: Clinical Hospital Centre Zagreb;Clinic for Neurology

location_facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

location_facility: Jacksonville Center For Clinical Research

location_facility: Queen Mary Hospital, Division of Geriatric Medicine

location_facility: Alexandrovska hospital; Neurology Department

location_facility: National Medical Academy of Postgraduate Education named after P.L.Shupik; Neurology Department #1

location_facility: Hospital General De Catalunya; Servicio de Neurologia

location_facility: Hospital Universitario Marques de Valdecilla; Servicio de Neurología

location_facility: Hopital Hautepierre; Centre dInvestigation Clinique

location_facility: Casa di Cura Policlinico; Dipartimento di Scienze Neuroriabilitative

location_facility: Neurodegenerative Disorders Research; Neurology

location_facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

location_facility: Hospital Regional Universitario Carlos Haya; Servicio de Neurologia

location_facility: Ondokuz Mayis University School of Medicine; Neurology

location_facility: UCLA Medical Center, Department of Neurology

location_facility: Steinwachs Klaus; Arztpraxis fur Neurologie u. Psychiatrie

location_facility: Clinica Universitaria de Navarra; Servicio de Neurología

location_facility: University of Szeged; Department of Psychiatry

location_facility: Ospedale San Giovanni Calibita Fatebenefratell;Neurologia

location_facility: Semmelweis University; Department of Neurology

location_facility: Fondazione Santa Lucia IRCCS; Neurologia e Riabilitazione Neurologica

location_facility: Institution of RAMS (Mental Health Research Center of RAMS)

location_facility: Osmangazi University School of Medicine,Neurology Department

location_facility: Karolinska Uni Hospital, Huddinge; Dept. of Geriatric Med

location_facility: Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; S.C. Geriatria

location_facility: State Autonomous Healthcare Institution "Republican Clinical Neurological Center

location_facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

location_facility: Hospital Universitari de Bellvitge; Servicio de Neurologia

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Skånes Universitetssjukhus Malmö, Minneskliniken

location_facility: SBEI of HPI The 1st Moscow State Medical University n.a. I.M. Sechenov of MOH of RF

location_facility: Hospital Prof. Dr. Fernando Fonseca; Servico de Neurologia

location_facility: Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre

location_facility: Ewha Womans University Mokdong Hospital; Dept of Neurology

location_facility: Hospital Virgen del Puerto. Servicio de Neurología

location_facility: Hacettepe University School of Medicine; Neurology

location_facility: Johnnie B. Byrd Sr. Alzheimer's Center & Research Institute

location_facility: Vilnius University Hospital Santariskiu Clinic

location_facility: Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie

location_facility: D.F.Chebotarev Institute of Gerontology NAMS;Depart of Age Physiology&Pathology of Nervous System

location_facility: Universitäres Zentrum für Altersmedizin und Rehabilitation

location_facility: National Hospital Organization Hiroshima-Nishi Medical Center

location_facility: University of California, Davis; Alzheimers Disease Center, Department of Neurology

location_facility: Charles University, Medical faculty, Hradec Kralove ;Department of Neurology

location_facility: Southern Illinois University, School of Medicine

location_facility: Drexel Univ College of Med; Clinical Research Group

location_facility: Ente Ospedaliero Ospedali Galliera; Ambulatorio di Neurologia

location_facility: Caulfield Hospital; Aged Psychiatry Research Unit

location_facility: Szabolcs-Szatmár-Bereg Megyei Kórházak - Jósa András Oktatókórház; Pszichiátria

summary: This randomized, double-blind, placebo-controlled, parallel group study will evaluate the efficacy and safety of crenezumab versus placebo in participants with prodromal to mild AD. Participants will be randomized 1:1 to receive either intravenous (IV) infusion of crenezumab or placebo every 4 weeks (Q4W) for 100 weeks. The final efficacy and safety assessment will be performed 52 weeks after the last crenezumab dose. Participants will then have the option to enter the Open Label Extension (OLE) study if eligible. Participants who do not enter the OLE study will have additional follow-up visits at 16 and 52 weeks after the last dose, primarily for safety and also for limited efficacy assessments.