title: A Parallel-group Treatment, Phase 2, Double-blind, Three-arm Study to Assess Efficacy and Safety of Finerenone Plus Empagliflozin Compared With Either Finerenone or Empagliflozin in Participants With Chronic Kidney Disease and Type 2 Diabetes

acronym: CONFIDENCE

summary:
Finerenone works by blocking a group of proteins, called mineralocorticoid receptor. An increased stimulation of mineralocorticoid receptor is known to trigger injury and inflammation in the kidney and is therefore thought to play a role in CKD.

Empagliflozin lowers blood sugar levels by increasing the excretion of glucose from the blood into the urine.

In this study, the researchers want to learn how well the combination of finerenone and empagliflozin helps to slow down the worsening of the participants' kidney function compared to either treatment alone. For this, the level of protein in the urine will be measured. The investigators also want to know how safe the combination is compared to either treatment alone.

Depending on the treatment group, the participants will either take the combination of finerenone and empagliflozin, or finerenone together with a placebo, or empagliflozin together with a placebo, once a day as tablets by mouth. A placebo looks like a treatment but does not have any medicine in it. Importantly, the participants will also continue to take their other current medicine for CKD and T2D.

The participants will be in the study for up to 7.5 months and will take the study treatments for 6 months. During the study, participants will visit the study site 7 times.

The study team will:

collect blood and urine samples
check the participants' vital signs
do a physical examination including height and weight
check the participants' heart health by using an electrocardiogram (ECG)
monitor the participants' blood pressure
ask the participants questions about how they are feeling and what adverse events they may be having An adverse event is any problem that happens during the trial. Doctors keep track of all events that happen in trials, even if they do not think the events might be related to the study treatments.

ipd_sharing_description:
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

location_country:
Denmark
Taiwan
Spain
Italy
Netherlands
Canada
Korea, Republic of
United States
France
Israel
Belgium
Japan
Germany

location_facility: Health Corporation of Galilee Medical Center

location_facility: Washington University School of Medicine

location_facility: Hospital Clínico Universitario de Santiago de Compostela

location_facility: Santa Rosa Medical Centers of Nevada / CCT Research

location_facility: Eastern Nephrology Associates / Greenville NC

location_facility: Diabetologische Schwerpunkt Praxis Dortmund

location_facility: Clalit Health Services Rabin Medical Center-Beilinson Campus

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Complejo Hospitalario Universitario A Coruña

location_facility: University of Tennessee Health Science Center

location_facility: Clalit Health Services through HaEmek Medical Center

location_facility: Zentrum für Diabetologie und Ernährungsmedizin

location_facility: MultiCare Rockwood Clinic Diabetes & Endocrinology Center

location_facility: University of Texas Health Science Center

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Regionaal ZH Jan Yperman Campus Mariaziekenhuis

location_facility: University of North Carolina Kidney Center

location_facility: Centre Hospitalier de l'Université de Montréal (CHUM)

location_facility: Complexo Hospitalario Universitario de Ferrol

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Taipei Medical University - Shuang Ho Hospital

location_facility: Yonsei University Wonju Christian Hospital

location_facility: Health Corporation of the Ziv Medical Center (R.A.)


title: A Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With the Sodium-glucose Transport Protein 2 (SGLT2) Inhibitor EmpaGliflozin in patiEnts With Non-alcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)

acronym: LEGEND

summary: The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

lead_sponsor: Inventiva Pharma

location_country:
United Kingdom
United States
France
Belgium
Netherlands

location_facility: Institute for Liver Health dba Arizona Liver Health

location_facility: Tandem Clinical Research - New Orleans Area Site

location_facility: Diabetes & Glandular Disease Clinic, P.A.

location_facility: Digestive Health Research of North Texas

location_facility: Digestive Health Research of Southern California

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


type: EudraCT Number

title: A Phase III, Randomised, Double-blind, Placebo-controlled, Multicentre, International Study of Durvalumab Plus Domvanalimab(AB154) in Participants With Locally Advanced (Stage III), Unresectable Non-small Cell Lung Cancer Whose Disease Has Not Progressed Following Definitive Platinum-based Concurrent Chemoradiation Therapy

summary: This is a Phase III, randomised, double-blind, placebo-controlled, multicentre, international study assessing the efficacy and safety of durvalumab (MEDI4736) and domvanalimab (AB154) compared with durvalumab plus placebo in adults with locally advanced (Stage III), unresectable NSCLC whose disease has not progressed following definitive platinum-based cCRT.

lead_sponsor: AstraZeneca

location_country:
Spain
Italy
United Kingdom
United States
Romania
Philippines
Belgium
South Africa
Japan
Poland
India
Turkey
Mexico
Norway
Malaysia
Brazil
Hungary
China
Germany
Taiwan
Greece
Korea, Republic of
France
Chile

intervention_type: Other


title: Efficacy, Safety, Tolerability and Quality of Life of Ongoing Individually Optimized Lipid-lowering Therapy With or Without Inclisiran (KJX839) - a Randomized, Placebo-controlled, Double-blind Multicenter Phase IV Study in Participants With Hypercholesterolemia

acronym: V-DIFFERENCE

summary: Study of efficacy, safety, tolerability and quality of life of inclisiran (KJX839) vs placebo, on top of ongoing individually optimized lipid-lowering therapy, in participants with hypercholesterolemia

ipd_sharing: Yes

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

lead_sponsor: Novartis Pharmaceuticals

location_country: Poland Spain Latvia Estonia France Germany Bulgaria Czechia


title: A Phase 3, Multi-Center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of CK-3773274 in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction

acronym: SEQUOIA-HCM

summary: The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction

lead_sponsor: Cytokinetics

location_country:
Denmark
Poland
Spain
Italy
United Kingdom
Netherlands
Hungary
United States
France
China
Israel
Germany
Czechia

location_facility: Washington University School of Medicine

location_facility: Liverpool Heart and Chest Hospital - Liverpool Heart and Chest Hospital NHS Foundation Trust- HWS Greater Glasgow and Clyde

location_facility: Azienda Ospedaliero Universitaria Careggi Dipartimento Cardiotoracovascolare - Cardiomiopatie Unit

location_facility: Cedars-Sinai Medical Center - Smidt Heart Institute Clinic

location_facility: Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

location_facility: Hospital Clinico Universitario Virgen de la Arrixaca

location_facility: Queen Elizabeth University Hospital - HWS Greater Glasgow and Clyde

location_facility: MedStar Medical Group Cardiology at Union Memorial

location_facility: The University of Texas Southwestern Medical Center

location_facility: Interni klinika kardiologie a angiologie

location_facility: Hospital of the University of Pennsylvania (University of Pennsylvania School of Medicine)

location_facility: Hopital Lariboisiere, Service de Cardiologie

location_facility: Holy Cross Hospital / Cardiology Associates

location_facility: CHU de Bordeaux Hopital Cardiologique Haut-Leveque

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Ascension St. John Clinical Research Institute

location_facility: Columbia University Medical Center/NY Presbyterian Hospital

location_facility: Narodowy Instytut Kardiologii Stefana Kardynała Wyszynskiego- Panstwowy Instytut Badawczy

location_facility: University of Virginia Health System University Hospital

location_facility: Semmelweis Egyetem Varosmajori Sziv es Ergyogyasazati Klinika

location_facility: Oxford Centre for Clinical Magnetic Resonance Research

location_facility: The Olga & Lev Leviev Heart Center The Chaim Sheba Medical Center

location_facility: Sanger Heart and Vascular Institute - HCM Clinic


title: A Pivotal Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of DMX-200 in Patients With Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving an Angiotensin II Receptor Blocker (ARB)

summary: DMX-200 (repagermanium) is a C-C chemokine receptor type 2 (CCR2) inhibitor that, when administered concurrently with an ARB, is designed to inhibit recruitment of monocytes implicated in the inflammatory chemokine environment of chronic disease. The purpose of this pivotal randomized double-blind study is to investigate the efficacy and safety of DMX-200 120 mg twice daily (BID) compared with placebo over a treatment period of 104 weeks in adult patients with biopsy-proven FSGS who are being treated with an ARB.

ipd_sharing: No

lead_sponsor: Dimerix Bioscience Pty Ltd

location_country:
Denmark
Taiwan
Brazil
Hong Kong
Spain
United Kingdom
Australia
New Zealand
Argentina
United States
France

location_facility:
ACTION3 Investigational Site 9
ACTION3 Investigational Site 15
ACTION3 Investigational Site 16
ACTION3 Investigational Site 2
ACTION3 Investigational Site 13
ACTION3 Investigational Site 5
ACTION3 Investigational Site 4
Action3 Investigator Site 3
Action3 Investigator Site 6
ACTION3 Investigational Site 12
ACTION3 Investigational Site 1
ACTION3 Investigational Site 3
ACTION 3 Investigator Site 19
ACTION3 Investigational Site 10
ACTION3 Investigational Site 14
ACTION3 Investigational Site 8
ACTION3 Investigational Site 6
ACTION3 Investigational Site 11
ACTION3 Investigational Site 18
ACTION3 Investigational Site 7
ACTION3 Investigational Site 17


title: A Multicentre Randomized Double-Blind Placebo Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis

acronym: IRIS

summary: The purpose of this study is to evaluate the efficacy and safety of IV antifrolumab in adult patients with Active Proliferative Lupus Nephritis

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean that all requests will be shared.

location_country:
Poland
Taiwan
Italy
Russian Federation
Mexico
Netherlands
Argentina
Thailand
Vietnam
Hungary
United States
France
China
India
Belgium
Japan
Germany
Peru
Bulgaria
Turkey


type: Registry Identifier

type: Other Identifier

title: A Phase 2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Advanced and Metastatic Gastrointestinal Cancer

summary:
The study is a phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants aged 18 years and older with advanced and metastatic gastrointestinal cancer. This study is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies.

Sub study 01 - Cohort A aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).

Sub study 02 - Cohort B1, B2 and B3 would focus on non MSI-H tumors with a large unmet need to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma (GC/GEJ), especially with low PD-L1 expression or after progression on prior PD1/PD-L1-based regimens.

Sub study 03 - Cohort C aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in participants with advanced unresectable or metastatic HCC who relapsed on prior PD1/PD-L1-based regimens.

Sub study 04 - Cohort D1 and D2 aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with either the anti-PD1 antibody pembrolizumab or with the anti-EGFR IgG1 antibody cetuximab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic colorectal cancer (mCRC).

status: Active, not recruiting

design_allocation: Non-Randomized

ipd_sharing_description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

lead_sponsor: Sanofi

location_country:
Poland
Spain
Italy
Netherlands
Korea, Republic of
France
United States
Chile
China
Belgium
Germany

location_facility: Seattle Cancer Care Alliance-Site Number:8400009

location_facility: Massachusetts General Hospital-Site Number:8400008

location_facility: Columbia University Medical Center-Site Number:8400003


title: A Randomized Phase III Trial of Trastuzumab + ALpelisib +/- Fulvestrant Versus Trastuzumab + Chemotherapy in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer. "ALPHABET Study".

acronym: ALPHABET

summary: Randomized phase III trial of trastuzumab + Alpelisib +/- fulvestrant versus trastuzumab + chemotherapy in patients with PIK3CA mutated previously treated HER2+ Advanced Breast cancer.

lead_sponsor: Spanish Breast Cancer Research Group

location_country: Spain Italy Austria Switzerland France Netherlands

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: ICO Badalona - Hospital Universitario Germans Trias i Pujol

location_facility: Sant'Anna Hospital - Città della salute e della scienza

location_facility: Ospedale di Bolzano Azienda Sanitaria Alto Adige

location_facility: Hospital Clínico Universitario de Valencia

location_facility: Hospital Universitario de Jerez de la Frontera

location_facility: Hospital Universitario Nuestra Señora de la Candelaria

location_facility: Hospital Universitario Arnau de Vilanova de Lleida

location_facility: Hospital Universitario Sant Joan de Reus

location_facility: Fundación Instituto Valenciano de Oncología

location_facility: Centre hospitalier universitaire de Poitiers

location_facility: Medizinische Universität Graz - LKH Graz

location_facility: Centre Régional De Lutte Contre Le Cancer Georges-François Leclerc

location_facility: Consorcio Hospital General Universitario de Valencia

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Hospital Universitario Regional de Malaga

location_facility: Hospital Universitario HM Sanchinarro - CIOCC Clara Campal

location_facility: Hospital General Universitario de Alicante

location_facility: Azienda Ospedaliero-Universitaria di Parma

location_facility: Hospital Universitario Arnau de Vilanova de Valencia

location_facility: Medizinische Universität Graz - Univ. Frauenklinik Graz

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Istituti Fisioterapici ospitaliersi - IFO - Istituti Regina Elena

location_facility: Hospital Provincial de Zamora (Complejo Asistencial de Zamora)

location_facility: Hospital Clinico Universitario Virgen de La Arrixaca

location_facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei tumori

location_facility: Complejo Hospitalario Universitario de Albacete

location_facility: Medizinische Universität Wien - Univ.klinikum AKH Wien

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: A.O. "SS Antonio e Biagio e Cesare Arrigo"

location_facility: Department of Oncology, ASUFC, PO Sm Misericordia

location_facility: Hospital Universitario Juan Ramón Jiménez

location_facility: Azienda Ospedaliero-Universitaria Careggi, University of Florence

location_facility: Hospital Universitario Clínico San Cecilio

location_facility: Centre hospitalier universitaire à Limoges

location_facility: Medizinische Universität Innsbruck - Univ.Klinik f. Frauenheilkunde Innsbruck

location_facility: Istituti Clinici Scientifici Maugeri SpA-SB

location_facility: Hospital de Terrassa - Consorci Sanitari de Terrassa

location_facility: Hospital Clínico Universitario de Santiago CHUS

location_facility: Complexo Hospitalario Universitario A Coruña

intervention_type: Biological


title: A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2)

source: euctr

ipd_sharing_description:
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the requests portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

location_country:
Portugal
Spain
Italy
Canada
Korea, Republic of
United States
France

summary: The study is intended to assess the safety and efficacy of perioperative treatment with Durvalumab in combination with Oleclumab or Monalizumab and platinum doublet chemotherapy; or MEDI5752 in combination with platinum doublet chemotherapy in participants with resectable, early-stage non-small cell lung cancer.


title: A Multinational, Open-label, Randomised, Controlled Study to Investigate Efficacy and Safety of NNC0365-3769 (Mim8) in Adults and Adolescents With Haemophilia A With or Without Inhibitors

summary:
This study is investigating how Mim8 works compared to other medicines in people with haemophilia A, who either have inhibitors or do not have inhibitors. Mim8 is a new medicine that will be used for prevention of bleeding episodes. Mim8 works by replacing the function of the missing clotting factor VIII (FVIII).

When and how often participants will receive Mim8 is dependent on their previous treatment - but is otherwise decided by chance. Mim8 will be injected into a skinfold on the stomach with a thin needle either once a week or once a month.

The study will last 54-124 weeks (12-29 months) depending on how long participants will be followed in run-in before they start treatment and if they continue in the follow period or transfer to an open label extension study. Participants will have 12-17 clinic visits.

ipd_sharing_description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

lead_sponsor: Novo Nordisk A/S

location_country:
Serbia
Saudi Arabia
Italy
Spain
United Kingdom
Lithuania
United States
Belgium
Japan
Romania
South Africa
Czechia
Poland
Portugal
Austria
Russian Federation
India
Israel
Turkey
Mexico
Malaysia
Slovakia
Canada
Switzerland
China
Germany
Denmark
Taiwan
Ireland
Latvia
Korea, Republic of
France
Netherlands


title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistamines

summary: The purpose of this study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.

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:
Taiwan
Spain
Italy
Russian Federation
Australia
Mexico
Argentina
Hungary
Korea, Republic of
United States
France
India
Puerto Rico
Colombia
Japan
Singapore
Turkey
Bulgaria
Czechia

location_facility: Hospital Universitario Gran Canaria Doctor Negrin

location_facility: Hospital General Universitario de Alicante, Edifico Consultas Externas


title: A Phase 1 Study of Oral LOXO-338, a Selective BCL-2 Inhibitor, in Patients With Advanced Hematologic Malignancies

summary: The purpose of this study is to find out whether the study drug, LOXO-338, is safe and effective in patients with advanced blood cancer. Patients must have already received standard therapy. The study may last up to approximately 3 years.

lead_sponsor: Eli Lilly and Company

location_country:
Poland
United States
Italy
France

location_facility: L'Institut Universitaire du Cancer de Toulouse Oncopole

location_facility: University of California San Francisco, Medical Center at Paranassus

location_facility: Indiana Blood & Marrow Transplantation (IBMT)

location_facility: Centre hospitalier universitaire de Haut Leveque

location_facility: Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu


title: A Multicenter, Open-label, Phase 2 Basket Study of MK-7684A, a Co-formation of Vibostolimab (MK-7684) With Pembrolizumab (MK-3475), With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors

summary: The purpose of this study is to determine the safety, tolerability, and preliminary efficacy of pembrolizumab/vibostolimab co-formulation (MK-7684A) with or without other anticancer therapies in participants with selected advanced solid tumors. The primary hypothesis is that pembrolizumab/vibostolimab co-formulation is superior to pembrolizumab alone in terms of objective response rate or progression-free survival in participants with cervical cancer.

lead_sponsor: Merck Sharp & Dohme LLC

location_country:
Poland
Taiwan
Spain
Italy
Netherlands
Canada
Korea, Republic of
France
United States
Chile
Israel
Colombia
Japan
Germany
Turkey

location_facility: Memorial Sloan Kettering- Commack ( Site 1021)

location_facility: Acibadem Universitesi Atakent Hastanesi ( Site 1208)

location_facility: Memorial Sloan Kettering - Westchester ( Site 1020)

location_facility: Sanford Cancer Center-Gynecologic Oncology ( Site 1015)

location_facility: Universitaetsklinikum Tuebingen-Department of Internal Medicine VIII - Medical Oncology, ECTU, Pne

location_facility: Istituto Europeo di Oncologia IRCCS-Divisione di Sviluppo di Nuovi Farmaci per Terapie Innovative (

location_facility: Memorial Sloan Kettering - Monmouth ( Site 1022)

location_facility: Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) ( Site 1121)

location_facility: James Lind Centro de Investigación del Cáncer ( Site 1404)

location_facility: Ankara City Hospital-Medical Oncology ( Site 1202)

location_facility: Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 1111)

location_facility: Sheba Medical Center-ONCOLOGY ( Site 1144)

location_facility: Clínica Vida Fundación - Sede Poblado ( Site 1422)

location_facility: National Cancer Center Hospital East ( Site 1321)

location_facility: HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO ( Site 1114)

location_facility: Ospedale San Raffaele-Oncologia Medica ( Site 1135)

location_facility: National Taiwan University Hospital-Oncology ( Site 1301)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1204)

location_facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1311)

location_facility: Trakya University-Medical Oncology ( Site 1207)

location_facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 1171)

location_facility: Chang Gung Medical Foundation-Linkou Branch ( Site 1304)

location_facility: Hadassah Medical Center-Oncology ( Site 1142)

location_facility: Instituto Nacional de Cancerología-Clinical Oncology ( Site 1425)

location_facility: Instituto Catalan de Oncologia - Hospital Duran i Reynals-Medical Oncology ( Site 1113)

location_facility: Princess Margaret Cancer Centre-Division of Medical Oncology and Hematology ( Site 1056)

location_facility: Fundación Cardiovascular de Colombia ( Site 1423)

location_facility: City of Hope Comprehensive Cancer Center ( Site 1001)

location_facility: University of California, Irvine (UCI) Health - UC Irvine Me-Chao Family Comprehensive Cancer Cente

location_facility: Institut Régional du Cancer Montpellier ( Site 1157)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 1209)

location_facility: Seoul National University Hospital-Internal Medicine ( Site 1312)

location_facility: HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 1117)

location_facility: Universitaetsklinikum Duesseldorf-Gastroenterology, Hepatology and Infectiology ( Site 1172)

location_facility: Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 1103)

location_facility: CENTRE LEON BERARD-Medical oncology ( Site 1151)

location_facility: Gustave Roussy-medicine departement ( Site 1153)

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-S.C. Sperimentazioni Cliniche ( Site 1134)

location_facility: Universitaetsklinikum Heidelberg-Nationales Centrum für Tumorerkrankungen ( Site 1180)

location_facility: Rambam Health Care Campus-Oncology ( Site 1141)

location_facility: Sainte Catherine Institut du Cancer Avignon Provence-Oncologie médicale ( Site 1156)

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1201)

location_facility: Istanbul Universitesi Cerrahpasa ( Site 1203)

location_facility: National Cancer Center Hospital ( Site 1322)

location_facility: Erasmus Medisch Centrum-Medical Oncology ( Site 1122)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Oddzial Badan Wczesnych Faz ( Site 1101

location_facility: NATIONAL CHENG-KUNG UNI. HOSP.-clinical trial center ( Site 1302)

location_facility: Memorial Sloan Kettering Cancer Center ( Site 1002)

location_facility: Osaka International Cancer Institute ( Site 1323)

location_facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 1104)

location_facility: Klinikum der Universität München Großhadern ( Site 1176)

location_facility: Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 1051)

location_facility: Sourasky Medical Center-Oncology ( Site 1143)

location_facility: Centre Georges François Leclerc ( Site 1155)


title: A Phase 2/3 Study of Evorpacept (ALX148) in Patients With Advanced HER2-Overexpressing Gastric/Gastroesophageal Junction Adenocarcinoma (ASPEN-06)

summary: A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma.

lead_sponsor: ALX Oncology Inc.

location_country:
Taiwan
Spain
Italy
United Kingdom
Korea, Republic of
France
United States
Belgium
Japan
Singapore
Czechia

location_facility: Guy's and Saint Thomas' NHS Foundation Trust

location_facility: Azienda Ospedaliero - Universitaria Careggi

location_facility: Fondazione IRCCS - Istituto Nazionale dei Tumori

location_facility: The Oncology Institute of Hope & Innovation

location_facility: Centre Hospitalier Universitaire de Bordeaux

location_facility: The Catholic University of Korea Saint Vincent's Hospital

location_facility: Universitair Ziekenhuis Leuven - Campus Gasthuisberg

location_facility: Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia

location_facility: Hospital Universitario Marqués de Valdecilla

location_facility: Seoul National University Bundang Hospital

location_facility: Centre Hospitalier Régional et Universitaire de Besançon - Hôpital Jean-Minjoz


title: A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy With PRA023 in Subjects With Moderately to Severely Active Ulcerative Colitis

acronym: ARTEMIS-UC

summary:
The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Ulcerative Colitis.

The purpose of Cohort 2 of the study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active ulcerative colitis who are companion diagnostic positive.

After the completion of the 12-week induction, all participants have the option to continue in the open-label extension for another 38 weeks.

lead_sponsor: Prometheus Biosciences, Inc.

location_country:
Poland
United Kingdom
Italy
Georgia
Australia
Canada
Hungary
United States
France
Israel
Belgium
Czechia

location_facility:
Prometheus Biosciences Selected Center
Prometheus Biosciences Selected Site
Prometheus Biosciences Selected Site #2
Prometheus Biosciences Selected Sites


title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of ABBV-154 in Subjects With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment

acronym: AIM-PMR

summary:
Polymyalgia rheumatica (PMR) is an inflammatory disease causing shoulder, hip, and neck pain and stiffness, in adults aged 50 years or older. This study evaluates how safe and effective ABBV-154 is in participants with glucocorticoid-dependent PMR. Adverse events and change in disease activity will be assessed.

ABBV-154 is an investigational drug being evaluated for the treatment of PMR. Participants will be randomized into 1 of 4 treatment groups or arms, each arm receiving a different treatment. There is a 1 in 4 chance that a participant will be assigned to placebo. Around 160 participants, of at least 50 years of age, with PMR will be enrolled in the study at approximately 95 sites worldwide.

The study is compromised of a 52 week double-blind, placebo-controlled period and a follow-up visit 70 days after the last dose of the study drug. All participants will receive a glucocorticoid taper along with the assigned dose of ABBV-154 or placebo, subcutaneously (SC) every other week (eow).

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

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, analyses plans, 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.

lead_sponsor: AbbVie

location_country:
Poland
Spain
Italy
Austria
Australia
Netherlands
Canada
New Zealand
United Kingdom
Hungary
Korea, Republic of
United States
France
Japan
Germany

location_facility: Hospital Unversitario Marques de Valdecilla /ID# 229297

location_facility: Articularis Healthcare Group, Inc d/b/a Low Country Rheumatology /ID# 228860

location_facility: Hospital Clinic de Barcelona /ID# 229295

location_facility: Matsuyama Red Cross Hospital /ID# 230458

location_facility: Debreceni Egyetem Klinikai Kozpont /ID# 241674

location_facility: Liverpool University Hospitals NHS Foundation Trust /ID# 245296

location_facility: Providence Medical Foundation /ID# 228681

location_facility: Osaka Medical and Pharmaceutical University Hospital /ID# 246530

location_facility: Hans Richard Barthel, M.D., Inc /ID# 231902

location_facility: Rheumatology Consultants - Clinical Research /ID# 232137

location_facility: Vital Medical Center Orvosi es Fogaszati Kozpont (Vital Medicina Kft.) /ID# 229674

location_facility: Paramount Medical Research Con /ID# 228839

location_facility: Universitair Medisch Centrum Groningen /ID# 227727

location_facility: CHRU Tours - Hopital Trousseau /ID# 228349

location_facility: ASL 3 Genovese - Ospedale la Colletta /ID# 229282

location_facility: Rheumatology Research Associates /ID# 230363

location_facility: Maastricht Universitair Medisch Centrum /ID# 227779

location_facility: Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz /ID# 229758

location_facility: Care Access Research, Huntington Beach /ID# 228677

location_facility: Azienda Ospedaliero-Universitaria Senese-Ospedale Santa Maria delle Scotte /ID# 245273

location_facility: Arthritis & Rheumatic Disease Specialties /ID# 245448

location_facility: Hospital for Special Surgery /ID# 228577

location_facility: Wellington Regional Hospital /ID# 229490

location_facility: Rheumatology Care Center PLLC /ID# 232306

location_facility: Fondazione IRCCS Policlinico /ID# 245274

location_facility: The Queen Elizabeth Hospital /ID# 229049

location_facility: Dartmouth-Hitchcock Medical Center /ID# 229557

location_facility: CMED Rehabilitacios es Diagnosztikai Kozpont /ID# 230065

location_facility: Rheuma-Zentrum Wien-Oberlaa GmbH /ID# 229436

location_facility: Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 228815

location_facility: Inland Rheum & Osteo Med Grp /ID# 228679

location_facility: Pest Megyei Flor Ferenc Korhaz /ID# 229676

location_facility: Arthritis and Rheumatism Associates /ID# 232089

location_facility: National Hospital Organization Shimoshizu National Hospital /ID# 230500

location_facility: Kyushu University Beppu Hospital /ID# 232250

location_facility: CHU Montpellier - Hôpital Lapeyronie /ID# 228347

location_facility: Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 231966

location_facility: MVZ Rheumatologie und Autoimmunmedizin Hamburg GmbH /ID# 228658

location_facility: University of Rochester Medical Center /ID# 232554

location_facility: Clinical Research Source, Inc. /ID# 231903

location_facility: Royal Prince Alfred Hospital /ID# 244888

location_facility: Hospital Universitario Canarias /ID# 229451

location_facility: Hospital General Universitario Gregorio Maranon /ID# 229302

location_facility: A.O.U. Citta della Salute e della Scienza di Torino /ID# 229080

location_facility: Ortopedyczno-Rehabilitacyjny Szpital Kliniczny im. Wiktora Degi /ID# 228314

location_facility: Arthritis & Osteo Medical Ctr /ID# 228680

location_facility: The Royal Free London NHS Foundation Trust /ID# 231707

location_facility: Csongrad-Csanad Megyei Dr. Bugyi Istvan Korhaz /ID# 229793

location_facility: AI Centrum Medyczne Sp. z o.o. sp.k. /ID# 228951

location_facility: Hopital de la Cavale Blanche /ID# 228348

location_facility: Obudai Egeszsegugyi Centrum Kft. /ID# 231121

location_facility: Portsmouth Hospitals University NHS Trust /ID# 245291

location_facility: Nova Reuma Domyslawska I Rusilowicz - Spolka Partnerska Lekarza Reumatologa I Fi /Id# 228466

location_facility: Obudai Egeszsegugyi Centrum Kft. Zalaegerszeg /ID# 229759

location_facility: Centre de Recherche Musculo-Squelettique /ID# 228392

location_facility: Azienda Ospedaliero-Universitaria di Modena /ID# 228825

location_facility: Timaru Medical Specialists Ltd /ID# 229098

location_facility: Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o /ID# 228357

location_facility: Four Rivers Clinical Research /ID# 228858

location_facility: Cardiff & Vale University Health Board /ID# 245297

location_facility: Rheumatology Associates of South Florida (RASF) - Clinical Research /ID# 232238

location_facility: North West Anglia NHS Foundation Trust /ID# 230866

location_facility: Rinku Hashimoto Rheumatology Orthopaedics /ID# 246532

location_facility: Hospital Clinico Universitario San Carlos /ID# 229296

location_facility: Consorci Corporacio Sanitaria Parc Tauli Sabadell /ID# 244866

location_facility: International Medical Research - Daytona /ID# 228765

location_facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela /ID# 228353

location_facility: Japanese Red Cross Okayama Hospital /ID# 230857

location_facility: Toyama Prefectural Central Hospital /ID# 230616

location_facility: Tokyo Medical And Dental University Hospital /ID# 232206

location_facility: CISSSBSL -Hopital regional de Rimouski /ID# 228394

location_facility: Charite Universitaetsmedizin Berlin - Campus Mitte /ID# 228661

location_facility: Kyungpook National University Hospital /ID# 228716

location_facility: West Tennessee Research Institute /ID# 228854

location_facility: CHU de Besancon - Jean Minjoz /ID# 244897

location_facility: Hanyang University Seoul Hospital /ID# 228719

location_facility: Hospital Clínico Universitario de Santiago-CHUS /ID# 244868

location_facility: DM Clinical Research - Tomball /ID# 245512


title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)

summary: The purpose of this study is to evaluate the efficacy and safety of nipocalimab in participants with primary Sjogren's syndrome (pSS) versus placebo.

primary_purpose: Other

ipd_sharing_description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Taiwan
Portugal
Spain
Italy
Netherlands
United States
France
Japan
Germany

location_facility: Rheumatology Associates Of South Florida

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: University of Iowa Hospitals and Clinics

location_facility: Szpital Uniwersytecki nr 2 im. dr. Jana Biziela w Bydgoszczy

location_facility: ULSAM, EPE - Hospital Conde de Bertiandos

location_facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia Presidio Spedali Civili

location_facility: Universitätsklinikum Carl Gustav Carus Dresden

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: P.O. Vittorio Emanuele Azienda Ospedaliero Universitaria 'Policlinico Vittorio Emanuele'

location_facility: Azienda Ospedaliero Universitaria S.Maria Della Misericordia

location_facility: Azienda Ospedaliera Universitaria Integrata Verona

location_facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone

location_facility: Centre for Rheumatology, Immunology and Arthritis

location_facility: Arizona Arthritis & Rheumatology Research, PLLC

location_facility: CHU de Grenoble - Hôpital Albert Michallon

location_facility: Malopolskie Badania Kliniczne Sp. z o.o. Sp. k.

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.

location_facility: Arizona Arthritis and Rheumatology Research, PLLC

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

location_facility: REUMED Zespol Poradni Specjalistycznych Filia nr 2

location_facility: Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im. prof. dr hab. med. Eleonory Reicher


title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate The Efficacy And Safety of Obinutuzumab in Patients With Systemic Lupus Erythematosus

acronym: ALLEGORY

summary: This parallel-group, double-blind, placebo-controlled study will evaluate the efficacy and safety of obinutuzumab versus placebo in participants with active, autoantibody-positive systemic lupus erythematosus (SLE) who are treated with standard-of-care therapy.

ipd_sharing_description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Brazil
Spain
Italy
Russian Federation
New Zealand
United Kingdom
Argentina
United States
France
Peru
South Africa
Mexico

location_facility: Azienda Ospedaliero-Universitaria Di Ferrara Arcispedale Santanna; Reumatologia

location_facility: Santa Casa de Misericordia; de Belo Horizonte

location_facility: Rheumatology Associates of Central Florida

location_facility: Hôpital Sud - CHU de Rennes Service interne

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Prywatna Praktyka Lekarska; Prof.UM dr hab.med Pawel Hryc

location_facility: Hospital General Universitario Gregorio Marañon; Servicio de Reumatología

location_facility: REUMATOP Grzegorz Rozumek, Karin Pistorius Spółka Jawna

location_facility: Winelands Medical Research; Medical Research

location_facility: Ch Pitie Salpetriere; Medecine Interne I

location_facility: Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY

location_facility: Metropolitan Clinical Research Institute

location_facility: Hospital Clinic i Provincial de Barcelona; Enfermedades Autoinmmunes

location_facility: FGBU "Federal Medical and Research Center named after V.A.Almazov" Russian Ministry of Health

location_facility: Centro de Investigación y Tratamiento Reumatológico S.C.

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: Addenbrooke'S Hospital; Rheumatology Research Unit

location_facility: Northwell Health Division of Rheumatology

location_facility: Paramount Medical Research & Consulting, LLC

location_facility: State Autonomous Healthcare Institution of Yaroslavl region "Clinical Hospital 9"

location_facility: Hospital de Basurto; Servicio de Reumatologia

location_facility: Unity Health - White County Medical Center- Rheumatology

location_facility: HOPITAL COCHIN; Internal Medicine Department

location_facility: Netcare Umhlanga Medical Centre; Rheumatology

location_facility: Royal Free Hospital; Department of Rheumatology

location_facility: Aintree University Hospitals NHS Foundation Trust

location_facility: IRCCS S. Raffaele; U.O. Immunologia, Reumatologia, Allergologia e Malattie Rare

location_facility: Ryazan State Medical University Named after I.P.Pavlov

location_facility: Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Medicina Interna

location_facility: Middlemore Hospital; Dept of Rheumatology

location_facility: Szpital Uniwersytecki; nr 2 im. Dr J. Biziela; Klinika Reumatologii i Ukladowych Chorob

location_facility: The Ohio State University Wexner Medical Center

location_facility: Hospital Universitario Vall d'Hebron; Servicio de Medicina Interna

location_facility: Centro de Investigacion Alberto Bazzoni S.A. de C.V.

location_facility: Ortopedyczno Rehab Szpital Klinic im Wiktora Degi UM; Oddzial Reumat Rehab i Chorob Wewnetrznych

location_facility: Unidad de Reumatologia Rehabilitacion Integral; Centro Medico Del Angel

location_facility: Centro de Investigación de Tratamientos Innovadores de Sinaloa (CITI)

location_facility: Chapel Allerton Hospital; Leeds Institution of Rheumatology Medicine

location_facility: Centro de Estudos em Terapias Inovadoras - CETI

location_facility: Suny Downstate Medical Center; Rheumatology

location_facility: Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova

location_facility: Republican clinical hospital named after G.G. Kuvatov

location_facility: Adventhealth Medical Group - Tampa - IM/Rheumatology

location_facility: Ser Servicos Especializados Em Reumatologia

location_facility: University of Colorado Denver, Barbara Davis Center, Center For Clinical Research

location_facility: Clínica San Juan Bautista CSJB; UNIDAD DE INVESTIGACION EN REUMATOLOGIA E INMUNOLOGIA CSJB

location_facility: Lancashire Teaching Hospitals NHS Foundation Trust; Lancashire Clinical Research Facility

location_facility: Asst Degli Spedali Civili Di Brescia; Reumatologia Ed Immunologia Clinica

location_facility: Centro Multidisciplinar de Estudos Clínicos - CEMEC*X*

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

location_facility: SBHI of Yaroslavl Region Clinical Hospital #3


title: A Two-part, Randomized, Placebo Controlled, Double Blind, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Linerixibat for the Treatment of Cholestatic Pruritus in Participants With Primary Biliary Cholangitis (PBC)

summary: This is a 2-part study in PBC participants with cholestatic pruritus and will evaluate the efficacy, safety and impact on health-related quality of life of linerixibat compared with placebo.

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

lead_sponsor: GlaxoSmithKline

location_country:
Poland
Brazil
United Kingdom
Italy
Russian Federation
Mexico
Argentina
Canada
United States
France
China
Israel
Belgium
Japan
Germany
Bulgaria
Czechia


title: A Randomized, Parallel-group, Double-blind, Placebo-controlled, Multicenter Phase III Trial to Investigate the Efficacy and Safety of Secukinumab 300 mg and 150 mg Administered Subcutaneously Versus Placebo, in Combination With a Glucocorticoid Taper Regimen, in Patients With Giant Cell Arteritis (GCA)

location_country:
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Czechia
Poland
Portugal
Russian Federation
Australia
Argentina
Turkey
Canada
Switzerland
Guatemala
Hungary
Germany
Bulgaria
Denmark
Estonia
Finland
France

summary: This is a phase III study of efficacy and safety of secukinumab versus placebo, in combination with glucocorticoid taper regimen, in patients with giant cell arteritis (GCA)


title: A Phase 2, Multicenter, Multi Arm, Study to Evaluate MK-1308A (Co-formulated Quavonlimab (MK-1308)/Pembrolizumab) Versus Other Treatments in Participants With Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) Stage IV Colorectal Cancer: (MK-1308A-008)

summary: The purpose of this study is to assess the efficacy and safety of co-formulated pembrolizumab/quavonlimab versus other treatments in participants with MSI-H or dMMR Metastatic Stage IV Colorectal Cancer.

location_country:
Poland
Spain
Italy
Russian Federation
United Kingdom
Canada
Korea, Republic of
United States
France
Turkey
Belgium
Germany

location_facility: UT Southwestern Medical Center ( Site 1551)

location_facility: Korea University Anam Hospital ( Site 1107)

location_facility: Northwest Medical Specialties, PLLC ( Site 1546)

location_facility: Hacettepe Universitesi-oncology hospital ( Site 1301)

location_facility: Charité Universitaetsmedizin Berlin - Campus Mitte ( Site 0604)

location_facility: Vanderbilt University Medical Center-Vanderbilt-Ingram Cancer Center ( Site 1509)

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital de la Ti-Service d'Hepato-Gastro-Enterologie et

location_facility: Hôpital Saint Antoine-Oncologie médicale ( Site 0508)

location_facility: Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology-Clinical Pharmacology and Chemotherapy

location_facility: Rostov Cancer Research Institute ( Site 1014)

location_facility: Ankara City Hospital-Medical Oncology ( Site 1306)

location_facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi-oncology ( Site 1305)

location_facility: Hospital Universitari Vall d'Hebron ( Site 1201)

location_facility: Beatson West of Scotland Cancer Centre-Clinical Trials Unit ( Site 1401)

location_facility: Centre Georges François Leclerc ( Site 0506)

location_facility: Saint-Petersburg City Clinical Oncology Dispensary-Department of chemotherapy ( Site 1001)

location_facility: The Catholic Univ. of Korea Seoul St. Mary's Hospital-Medical Oncology ( Site 1106)

location_facility: HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 1206)

location_facility: Baylor Scott & White Medical Center - Temple-Division of Hematology/Oncology ( Site 1549)

location_facility: University Hospital Coventry & Warwickshire ( Site 1406)

location_facility: McGill University Health Centre-CIM - Oncology ( Site 0306)

location_facility: Universitaetsklinikum Carl Gustav Carus Dresden-Medical Dept I - Medical Oncology ( Site 0601)

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0802)

location_facility: Hospital Universitario Marqués de Valdecilla ( Site 1202)

location_facility: Hospital Universitario Central de Asturias-Medical Oncology ( Site 1203)

location_facility: Luxmed Onkologia sp. z o. o. ( Site 0915)

location_facility: Samsung Medical Center-Division of Hematology/Oncology ( Site 1102)

location_facility: Université Catholique de Louvain-Namur - Centre Hospitalier -Oncology ( Site 0102)

location_facility: DOLNOSLASKIE CENTRUM ONKOLOGII PULMONOLOGII I HEMATOLOGII ( Site 0920)

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center ( Site 1303)

location_facility: Hospital Clinico San Carlos-Oncology Department ( Site 1204)

location_facility: Velindre Cancer Centre-Research and Development ( Site 1415)

location_facility: Severance Hospital, Yonsei University Health System-Medical oncology ( Site 1104)

location_facility: Hopital Claude Huriez - CHU de Lille ( Site 0510)

location_facility: Seoul National University Hospital-Internal Medicine ( Site 1101)

location_facility: Istituto Oncologico Veneto IRCCS ( Site 0804)

location_facility: Centre Hospitalier Universitaire de Poitiers ( Site 0511)

location_facility: Republican Clinical Oncology Dispensary-Chemotherapy #3 ( Site 1006)

location_facility: Kyungpook National University Chilgok Hospital-Hematology/oncology ( Site 1103)

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Onkologii i Radioterapii ( Site

location_facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale-Department of Abdominal Oncology ( Site 0803)

location_facility: University Cancer & Blood Center, LLC ( Site 1521)

location_facility: The Moncton Hospital-Oncology ( Site 0307)

location_facility: CHU Rangueil-Digestive oncology department ( Site 0502)

location_facility: Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0903)

location_facility: Icahn School of Medicine at Mount Sinai ( Site 1528)

location_facility: First Moscow State Medical University I.M. Sechenov-Interhospital Institution Health Management Cl

location_facility: Asan Medical Center-Department of Oncology ( Site 1105)

location_facility: UCLH-Cancer Clinical Trials Unit ( Site 1402)

location_facility: University of Chicago Medical Center-Medicine - Section of Hematology/Oncology - Gastrointestinal P


title: A Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Safety, Tolerability, and Efficacy of AXA1125 in Subjects With Non Cirrhotic, Non Alcoholic Steatohepatitis and Fibrosis (EMMPACT)

summary: This study will compare the effects of AXA1125, an orally active mixture of amino acids, compared to placebo, on improving fat and inflammation (steatohepatitis) as well as fibrosis in subjects with non alcoholic steatohepatitis (NASH). as well as the safety and tolerability of AXA1125. Subjects will take one of two different doses of AXA1125 or a placebo twice daily, and a liver biopsy will be done at the beginning and end of the 48-week study.

lead_sponsor: Axcella Health, Inc

location_country:
Poland
United Kingdom
Australia
Canada
Puerto Rico
United States
France

location_facility: ENCORE Borland Groover Clinical Research

location_facility: Indiana University (IU) School of Medicine

location_facility: Velocity - Advanced Clinical Research - Salt Lake City of Gastroenterolog

location_facility: Virginia Commonwealth University Medical College of Virginia

location_facility: The National Diabetes & Obesity Research Institute

location_facility: Lucas Research - Diabetes & Endocrinology Consultants, PC


title: A Phase III Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of BI 425809 Once Daily Over 26 Week Treatment Period in Patients With Schizophrenia (CONNEX-2)

lead_sponsor: Boehringer Ingelheim

ipd_sharing_description:
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

location_country:
Croatia
Poland
Brazil
Serbia
Spain
Argentina
Ukraine
Hungary
Korea, Republic of
United States
Chile
France
Japan
Netherlands
Slovakia

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: CENYDET-Centro Neurobiológico y de Estres Traumático (Biopsychomedical Research Group S.R.L.)

location_facility: Resolution Psychopharmacology Research Institute

location_facility: Clínica Viver - Centro de Desospitalização Humana

location_facility: ASCLEPES Research Centers, P.C. dba Alliance Research

location_facility: Fundación FunDaMos para la asistencia e investigación en psiquiatría

location_facility: Communal Non-Profit Enterprise "Regional Clinical Psychiatric Hospital" of Kirovohrad Regional Council

location_facility: Medical Corporation Yamadakai Yatsushiro Welfare Hospital

location_facility: National Hospital Organization Sakakibara Hospital

location_facility: Clinica Privada de Salud Mental Santa Teresa de Avila

location_facility: Benito Menni Complejo Asistencial en Salud Mental

location_facility: Okehazama Hospital Fujita Kokoro Care Center

location_facility: Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

location_facility: Tokyo Medical and Dental University Hospital

location_facility: Osaka City Hospital Organization Osaka City General Hospital

location_facility: Psychiatricka Ambulancia Psycholine s.r.o.

location_facility: CEN (Centro Especializado Neurociencias)

location_facility: National Hospital Organization Shimofusa Psychiatric Medical Center

location_facility: Hospital Provincial. Complejo Asistencial de Zamora

location_facility: Special Hospital for Psychiatric Diseases Sveti Vračevi

location_facility: University Clinical Center of Kragujevac

summary:
This study is open to adults with schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called BI 425809 improves learning and memory in people with schizophrenia.

Participants are put into two groups randomly, which means by chance. One group takes BI 425809 tablets and the other group takes placebo tablets. Placebo tablets look like BI 425809 tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia.

During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups.

Participants are in the study for about 8 months. During this time, they visit the study site about 15 times and get about 3 phone calls from the study team. The doctors also regularly check participants' health and take note of any unwanted effects.


title: LIBRETTO-432: A Placebo-controlled Double-Blinded Randomized Phase 3 Study of Adjuvant Selpercatinib Following Definitive Locoregional Treatment in Participants With Stage IB-IIIA RET Fusion-Positive NSCLC

summary: The reason for this study is to see if the study drug, selpercatinib, compared to placebo is effective and safe in delaying cancer return in participants with early-stage non-small cell lung cancer (NSCLC), who have already had surgery or radiation. Participants who are assigned to placebo and stop the study drug because their disease comes back or gets worse have the option to potentially crossover to selpercatinib. Participation could last up to three years.

ReferenceType: derived

ReferenceCitation: Tsuboi M, Goldman JW, Wu YL, Johnson ML, Paz-Ares L, Yang JC, Besse B, Su W, Chao BH, Drilon A. LIBRETTO-432, a phase III study of adjuvant selpercatinib or placebo in stage IB-IIIA RET fusion-positive non-small-cell lung cancer. Future Oncol. 2022 Sep;18(28):3133-3141. doi: 10.2217/fon-2022-0656. Epub 2022 Aug 11. Review.

ipd_sharing_description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

lead_sponsor: Loxo Oncology, Inc.

location_country:
Spain
Italy
United Kingdom
Ukraine
United States
Belgium
Japan
Romania
Czechia
Poland
Hong Kong
Austria
Australia
Russian Federation
Puerto Rico
India
Israel
Turkey
Mexico
Singapore
Sweden
Brazil
Canada
China
Germany
Denmark
Taiwan
Greece
Korea, Republic of
France
Netherlands

location_facility: National Taiwan University Cancer Centre

location_facility: IBCC - Instituto Brasileiro de Controle do Câncer

location_facility: Azienda Sanitaria Ospedaliera S Luigi Gonzaga

location_facility: Chonnam National University Hwasun Hospital

location_facility: Rajiv Gandhi Cancer Institute And Research Centre

location_facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

location_facility: Arkhangelsk Clinical Oncological Dispensary

location_facility: Tongji Medical College of Huazhong University of Science and Technology

location_facility: Hospital Universitario La Fe de Valencia

location_facility: Actualidad Basada en la Investigación del Cáncer

location_facility: Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne

location_facility: Baskent University Dr. Turgut Noyan Research and Training Center

location_facility: Harbin Medical University Cancer Hospital

location_facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

location_facility: Goztepe Prof Dr Suleyman Yalcin Sehir Hastanesi

location_facility: Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital

location_facility: National medical research center of oncology n. a. N. N. Petrov

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Nemocnice AGEL Ostrava-Vitkovice a.s.-Plicni oddeleni

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Stockton Hematology Oncology Medical Group

location_facility: Southern Medical University Nanfang Hospital

location_facility: Rashtrasant Tukdoji Regional Cancer Hospital and Research Centre (RSTRCH)

location_facility: Complejo Asistencial Universitario de León - Hospital de León

location_facility: Beijing Friendship Hospital Affiliate of Capital University

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Communal Enterprise "Odesa Regional Clinical Hospital"

location_facility: Izmir Katip Celebi University Training and Research Hospital Oncology

location_facility: Instituto de Educação, Pesquisa e Gestão em Saúde

location_facility: Universitair Medisch Centrum St Radboud Nijmegen

location_facility: University clinic of Sumy State University

location_facility: Sotiria Thoracic Diseases Hospital of Athens

location_facility: Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"

location_facility: Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca

location_facility: Inonu University Medical Faculty Oncology

location_facility: COT - Centro Oncológico do Triângulo S.A.

location_facility: Assistance Publique Hôpitaux de Marseille - Hôpital Nord

location_facility: West China Hospital of Sichuan University

location_facility: Seoul National University Bundang Hospital

location_facility: Xiangya Hospital, Central South University

location_facility: Tangdu Hospital of Fourth Military Medical University of Chinese People's Liberation Army

location_facility: University General Hospital of Heraklion

location_facility: Hospital Universitario Central de Asturias

location_facility: Wielkopolskie Centrum Pulmonologii i Torakochirurgii

location_facility: Charité-Campus Benjamin Franklin-Hematology and Oncology

location_facility: Chang Gung Memorial Hospital - Kaohsiung Branch

location_facility: Kyungpook National University Medical Center Chilgok Hospital

location_facility: City Hospital, Nottingham University Hospitals

location_facility: Krakowski Szpital Specjalistyczny im. Jana Pawa II

location_facility: Hospital Universitario Virgen de la Arrixaca

location_facility: First Affiliated Hosp of College of Med, Zhejiang University


title: A Phase 1, Multi-center, Open-label, Dose Finding Study of CC-96191 in Subjects With Relapsed or Refractory Acute Myeloid Leukemia

summary:
This Phase 1, clinical study of CC-96191 will explore the safety, tolerability and preliminary biological and clinical activity of CC-96191 as a single-agent in the setting of Relapsed or refractory acute myeloid leukemia (R/R AML).

The dose escalation (Part A) of the study will explore escalating intravenous doses of CC-96191 to estimate the MTD and/or RP2D of CC-96191 as monotherapy.

The expansion (Part B), will further evaluate the safety and efficacy of CC-96191 administered at or below the MTD in one or more expansion cohorts in order to determine the RP2D.

ipd_sharing_description:
Information relating to our policy on data sharing and the process for requesting data can be found at the following link:

https://www.celgene.com/research-development/clinical-trials/clinical-trials-data-sharing/

lead_sponsor: Celgene

location_country:
United States
Canada
France

location_facility: Mt. Sinai Medical Center Division of Hematology/Oncology

location_facility: Princess Margaret Hospital University Health Network

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: Winship Cancer Institute of Emory University


title: A 2-year Extension Study to Evaluate Long-term Effectiveness of Mavenclad® in Participants Who Have Completed Trial MS700568_0022 (MAGNIFY MS) (Magnify MS Extension)

summary: The primary purpose of this study is to evaluate the long-term effectiveness of Mavenclad® tablets, in terms of disease activity and safety, in participants with highly-active relapsing multiple sclerosis (RMS) previously participating in the MAGNIFY MS trial MS700568_0022 (NCT03364036).

ipd_sharing_description: Per company policy, following approval of a new product or a new indication for an approved product in both the EU and the US, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany will share study protocols, anonymized patient level and study level data and redacted clinical study reports from clinical trials in patients with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website https://www.merckgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

location_country:
Poland
Spain
Italy
Austria
Australia
United Kingdom
Finland
Canada
Sweden
Hungary
France
Israel
Germany
Czechia

location_facility: Indywidualna Praktyka Lekarska Prof. Konrad Rejdak

location_facility: Akademiskt Specialist Centrum - Centrum för Neurologi,

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: CHU de Montpellier Hôpital Gui de Chauliac- Département de Neurologie

location_facility: Università "G. D'Annunzio" Chieti-Pescara Ospedale Cliniciz

location_facility: Children's Hospital, London Health Sciences Centre- Pediatrics

location_facility: Dipartimento di internistica clinica e sperimentale "Flaviano Magrassi"Università degli studi della Campania "Luigi Vanvitelli"

location_facility: IRCSS Neuromed Istituto Neurologico Mediterraneo

location_facility: Nemocnice Pardubickeho kraje, a.s. Pardubicka nemocnice

location_facility: Samodzielny Publiczny Szpital Kliniczny nr 7 SUM

location_facility: Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko SUM w Katowicach

location_facility: Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpo


acronym: AVONELLE-X

title: A Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Tolerability of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (AVONELLE-X)

ipd_sharing_description:
Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/).

For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

enrollment_type: Actual

location_country:
Spain
Italy
United Kingdom
United States
Japan
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Israel
Turkey
Mexico
Singapore
Brazil
Canada
Switzerland
Hungary
Germany
Bulgaria
Denmark
Taiwan
Korea, Republic of
France
Netherlands

location_facility: Northern California Retina Vitreous Associates

location_facility: Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

location_facility: Universitätkslinikum Düsseldorf, Augenklinik; Klinik fürAugenheilkunde

location_facility: Changhua Christian Hospital; Department of Ophthalmology

location_facility: Hospital Universitario Rio Hortega; Servicio de Oftalmologia

location_facility: Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály

location_facility: Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

location_facility: Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

location_facility: Gazi University Faculty of Medicine; Department Of Ophthalmology

location_facility: Ankara Baskent University Medical Faculty; Department of Ophthalmology

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

location_facility: Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

location_facility: University Retina and Macula Associates, PC

location_facility: Hospital de Sao Joao; Servico de Oftalmologia

location_facility: Universitätsklinikum Freiburg, Klinik für Augenheilkunde

location_facility: Retina Consultants of Southern California

location_facility: Specjalistyczny Ośrodek Okulistyczny Oculomedica

location_facility: ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

location_facility: Hopital de la croix rousse; Ophtalmologie

location_facility: Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

location_facility: Augenabteilung am St. Franziskus-Hospital

location_facility: Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

location_facility: Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

location_facility: Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

location_facility: Northwestern Medical Group/Northwestern University

location_facility: Hospital Universitario Miguel Servet; Servicio de Oftalmologia

location_facility: The Ohio State University Havener Eye Institute

location_facility: Sjællands Universitetshospital, Roskilde; Øjenafdelingen

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

location_facility: Ankara University Medical Faculty; Department of Ophthalmology

location_facility: Szpital Specjalistyczny nr 1; Oddzial Okulistyki

location_facility: Tokyo Women's Medical University Hospital

location_facility: Centre Paradis Monticelli; Ophtalmologie

location_facility: Chang Gung Medical Foundation - Linkou; Ophthalmology

location_facility: California Eye Specialists Medical group Inc.

location_facility: University of British Columbia - Vancouver Coastal Health Authority

location_facility: Kansai Medical University Medical Center

location_facility: Ege University Medical Faculty; Department of Ophthalmology

location_facility: Gabinet Okulistyczny Prof Edward Wylegala

location_facility: "Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

location_facility: Taipei Veterans General Hospital; Ophthalmology

location_facility: Hacettepe University Medical Faculty; Department of Ophthalmology

location_facility: Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia

location_facility: Shiga University Of Medical Science Hospital

location_facility: Japanese Red Cross Nagasaki Genbaku Hospital

location_facility: Bristol Eye Hospital;Retinal Treatment and Research Unit

location_facility: Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia

location_facility: Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning

location_facility: Southeastern Retina Associates Chattanooga

location_facility: Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica

location_facility: Specialized Hospital for Active Treatment of Eye Diseases Zora

location_facility: Seoul National University Bundang Hospital

location_facility: National Defense Medical College Hospital

location_facility: Tokyo Medical University Hachioji Medical Center

location_facility: University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit

location_facility: Mid Atlantic Retina - Wills Eye Hospital

location_facility: Gloucestershire Hospitals NHS Foundation Trust

location_facility: VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

location_facility: Hospital dos de maig; servicio de oftalmologia

location_facility: University of California, Davis, Eye Center

location_facility: Pentagram Eye Hospital (Medical Center "Pentagram")

location_facility: 1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology

location_facility: FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences

location_facility: Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

location_facility: Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch

location_facility: Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

location_facility: Clinica Universitaria de Navarra; Servicio de Oftalmologia

location_facility: Moorfields Eye Hospital NHS Foundation Trust

location_facility: Selcuk University Faculty of Medicine; Department Of Ophthalmology

location_facility: Queen Mary Hospital; Department of Ophthalmology

summary: This is a multicenter long-term extension study designed to evaluate the long-term safety and tolerability of faricimab 6 milligrams (mg) administered by intravitreal injection at a personalized treatment interval to participants with neovascular age-related macular degeneration who enrolled in and completed one of the Phase III studies: GR40306 (NCT03823287) or GR40844 (NCT03823300), also referred to as the parent studies. Eligible patients who consent to participate in this study will be enrolled upon completion of the end-of-study visit in the parent study.


title: A Phase II, Open-label, Single-arm Study of Berzosertib (M6620) in Combination With Topotecan in Participants With Relapsed Platinum-resistant Small-Cell Lung Cancer (DDRiver SCLC 250)

summary: The main purpose of this study is to assess efficacy, safety, tolerability and pharmacokinetics (PK) of Berzosertib in combination with Topotecan in participants with relapsed, platinum-resistant small-cell lung cancer (SCLC). This study will be conducted in two parts: safety run-in part and main part. The safety run-in part will be conducted in Japan.

ipd_sharing_description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Spain
Italy
United States
France
China
Belgium
Japan

location_facility: Institut Jules Bordet - Department of Institut Jules Bordet

location_facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS - UOC Oncologia Medica

location_facility: Osaka Medical and Pharmaceutical University Hospital

location_facility: The First Affiliated Hospital of Zhejiang University school of medicine

location_facility: Centre Hospitalier Intercommunal de Créteil - Service de Pneumologie

location_facility: Union Hospital of Tongji Medical College, Huazhong University of Science and Technology

location_facility: Hospital Clinico Universitario Virgen de la Victoria - Oncology Service

location_facility: Cotton-O'Neil Clinical Research Center, Hematology and Oncology

location_facility: Istituto Nazionale Tumori Regina Elena IRCCS

location_facility: CHU Poitiers - Hôpital la Milétrie - service d'oncologie médicale

location_facility: Hopital Albert Calmette - CHU Lille - service de pneumologie et immuno allergologie

location_facility: Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

location_facility: The First Affiliated Hospital of Xi'an Jiaotong University

location_facility: Cancer & Hematology Centers of Western Michigan

location_facility: Hospital Universitario Virgen de la Victoria

location_facility: CHU Nantes - Hôpital Guillaume et René Laënnec - Service de Pneumologie

location_facility: CHU de Strasbourg - Nouvel Hôpital Civil - Service de Pneumologie

location_facility: IRCCS Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori "Dino Amadori" - IRST

location_facility: Azienda Ospedaliero Universitaria Pisana (Presidio di Cisanello)


title: A Phase 1/2, Open-label, Multicenter Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CC-90011 in Combination With Venetoclax and Azacitidine in R/R Acute Myeloid Leukemia (AML) and Treatment-naïve Subjects With AML Who Are Not Eligible for Intensive Induction Chemotherapy

summary: CC-90011-AML-002 is a Phase 1/2, open-label, multicenter study to assess the safety, tolerability, and preliminary efficacy of CC-90011 given concurrently with Venetoclax and Azacitidine. This study will include 3 parts: a dose escalation part in R/R AML, a dose escalation part in ndAML (treatment-naïve participants with AML who are ≥ 75 years of age or are ≥ 18 to 74 years of age and otherwise not eligible for intensive induction chemotherapy), and a randomized dose expansion part in ndAML of Venetoclax and Azacitidine with or without CC-90011.

status: Completed

study_completion_date_type: Actual

location_country:
Spain
Italy
Austria
United States
France
Belgium
Norway

location_facility: Centre Hospitalier Lyon Sud - Hospices Civils de Lyon Groupement Hospitalier Sud

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

location_facility: Hospital Universitario Virgen del Rocio - PPDS

location_facility: Salzburger Landkliniken St. Johanns-Spital

location_facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

location_facility: Ohio State University Medical CenterJames Cancer Hospital

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Ospedale Santa Maria Della Misericordia Di Perugia

location_facility: The University of Texas - MD Anderson Cancer Center

location_facility: University of Miami Miller School of Medicine Jackson Memorial Hospital

location_facility: Winship Cancer Institute of Emory University

status_simplified: Completed


title: A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants Who Have Thrombotic Microangiopathy Associated With a Trigger

summary: This study will investigate the efficacy and safety of ravulizumab compared to placebo in adult participants with thrombotic microangiopathy (TMA) associated with a trigger. Participants will be randomized to receive either ravulizumab plus best supportive care or placebo plus best supportive care. The treatment period is 26 weeks followed by a 26-week off-treatment follow-up period.

lead_sponsor: Alexion Pharmaceuticals

location_country:
Taiwan
Spain
Italy
United Kingdom
Canada
Korea, Republic of
United States
France
Belgium
Japan
Netherlands


acronym: SUNLIGHT

title: An Open-label, Randomized, Phase III Study Comparing Trifluridine/Tipiracil in Combination With Bevacizumab to Trifluridine/Tipiracil Monotherapy in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT Study)

lead_sponsor: Taiho Oncology, Inc.

location_country:
Denmark
Poland
Brazil
Spain
Italy
Austria
Russian Federation
Ukraine
Hungary
Puerto Rico
United States
France
Belgium
Germany

location_facility: "Klinikum der Universität München Campus Großhadern, Medizinische Klinik und Poliklinik III"

location_facility: "Wojskowy Instytut Medyczny Klinika Onkologii"

location_facility: U.O. Oncologia Medica Azienda Ospedaliera Regionale - Potenza Ospedale "San Carlo" - Potenza

location_facility: "Hôpital Européen Georges Pompidou Oncologie Hépatogastroenterologie-oncologie digestive"

location_facility: "U.O. di Oncologia Medica Polo Oncologico Edificio 22 Stabilimento Santa Chiara AZ. Osped. Universitaria Pisana"

location_facility: "Hospital de la Santa Creu I Sant Pau Oncología Medica"

location_facility: "Aalborg Universitetshospital, Syd Onkologisk Afdeling"

location_facility: "Hospital Universitario Ramón y Cajal Servicio de Oncologia Médica"

location_facility: "Hospital Albert Einstein Instituto de Ensino e Pesquisa"

location_facility: Petz Aladar Megyei Oktato Korhaz Onkoradiologiai Osztaly

location_facility: "ICESP - Instituto do Câncer do Estado de São Paulo Centro Integrado de Pesquisa"

location_facility: "CHU de Poitiers Pole Régional de Cancérologie"

location_facility: "LLC Ukrainian Center of Tomotherapy "Tomoclinic", Chemoteraphy Department"

location_facility: "UZ Leuven Campus Gasthuisberg Digestieve Oncologie"

location_facility: "Saint Petersburg City Oncology Clilnic "

location_facility: "Centre de lutte contre le cancer Francois Baclesse UCP Digestif"

location_facility: "Clinical and diagnostic Centre of Medics-rey Inter. Group LLC Hospital of Israeli Oncology "LISOD"

location_facility: "Moscow City Oncology Hospital # 62 chemotherapy department"

location_facility: "Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kp. Onkoterápiás Klinika"

location_facility: "Instituto Brasileiro de Controle do Câncer Unidadde de Pesquisa Clínica"

location_facility: "Markusovszky Egyetemi Oktatokorhaz Onkoradiologiai Osztaly"

location_facility: Investigative Clinical Research - Indianapolis

location_facility: "CHU Jean Minjoz Service d'oncologie médicale"

location_facility: "Arkhangelsk Clinical Oncology Dispensary chemotherapy department"

location_facility: "National Medical Research Centre of Radiology Moscow Research Oncology Institute N.A. Herzen"

location_facility: Unità Operativa di Oncologia ed Ematologia Istituto Clinico Humanitas"

location_facility: "National Cancer Institute Department of minimally invasive and endoscopic surgery, interventional radiology "

location_facility: "H. Valle de Hebrón Servicio de Oncología - (VHIR)"

location_facility: Unità Operativa Complessa Oncologia Medica 1 Istituto Oncologico Veneto - IRCCS"

location_facility: Pan American Center for Oncology Trials, LLC

location_facility: "Allgemeines Krankenhaus - Universitätskliniken Klinische Abteilung für Onkologie"

location_facility: "Regionshospitalet Herning, Hospitalsenheden Vest Onkologisk Afdeling"

location_facility: "Bekes Megyei Kozponti Korhaz Onkologia"

location_facility: SBIH of YR ""Clinical oncology hospital chemotherapy department"

location_facility: "Cherkasy Regional Oncological Dispensary Regional Clinical Oncological Centre"

location_facility: "H. GENERAL DE VALENCIA Servicio de Oncología Médica"

location_facility: "Scientific Centre for Specialized Medical Care (oncological) Chemotherapy"

location_facility: "Universitair Ziekenhuis Antwerpen Oncologie"

location_facility: "Hospital de Base Centro Integrado de Pesquisa"

location_facility: "Hospital Universitario Marqués de Valdecilla oncología medica"

location_facility: DuPage Medical Group - Joliet Oncology-Hematology Associates

location_facility: "SP ZOZ Szpital Uniwersytecki w Krakowie Oddzial Kliniczny Onkologii"

location_facility: "Hospital Uni. Reina Sofía - Hospital Provincial Departamento de Oncología Médica"

location_facility: "Medizinische Universität Innsbruck Univ.-Klinik für Innere Medizin V"

location_facility: "Medical Center n.a. Acad. Spizhenko "Syber Clinic Spizhenko"" Department of Oncology"

location_facility: Dipartimento di Onco-Ematologia Ospedale IRCSS Casa Sollievo della Sofferenza"

location_facility: "S.C. Oncologia - Responsabile S.S. Sperimentazioni Cliniche ASMN - IRCCS di Reggio Emilia"

location_facility: "Orszagos Onkologiai Intezet "B" Belgyogyaszati-Onkologiai O. Es Klin. Farmakologiai O."

location_facility: "Oncology dispensary No.2 Oncology department"

location_facility: "Podillia Regional Oncology Centre Chemotherapy Department"

location_facility: S.C. di Oncologia Medica Addominale Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

location_facility: "CHU Morvan Institut de Cancérologie et d'Hématologie"

location_facility: "Charite Universitätsmedizin Medizinische Klinik m.S. Haemat., Onko., Tumorimmunologie"

location_facility: "MI ""Dnipropetrovsk City Multi-field Clinical Hospital #4"" Department of Oncology"

location_facility: "Hospital Universitario Miguel Servet Edif. de maternidad planta 8. Servicio de Oncología Médica "

location_facility: "Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie Państwowy Instytut Badawczy Klinika Onkologii i Radioterapii"

location_facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists

location_facility: "JNSZ Megyei Hetenyi Geza Korhaz es Rendelointezet Megyei Onkologiai Centrum"

location_facility: "Opolskie Centrum Onkologii im. Tadeusza Koszarowskiego Oddzial Onkologii Klinicznej"

location_facility: "National Medical Research Center of Oncology N.N. Petrova "

location_facility: "Debreceni Egyetem Orvos es Egeszsegtudomanyi Centrum Onkologiai Intezet"

location_facility: "Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Slupsku Sp. z o.o."

location_facility: "Clinical Oncology Dispensary No.1 Chemotherapy Department"

location_facility: U.O.C. OncoEmatologia Dipartimento di Medicina di Precisione c/o Nuovo Policlinico Università degli studi della Campania "Luigi Vanvitelli"

location_facility: "Russian Cancer Research Center n.a. NN Blokhin Clinical Pharmacology and Chemotherapy"

location_facility: "Omsk Clinical Oncologic Dispensary Chemotherapy"

location_facility: Oncologia Medica A.O. Universitaria di Cagliari Policlinico Universitario "Duilio Casula" di Monserrato"

location_facility: "Hospital do Câncer de Barretos - Fundação Pio XII Unidade de Pesquisa Clínica"

location_facility: "H.VIRGEN DEL ROCIO Servicio de Oncología Médica"

location_facility: "Szent Imre Egyetemi Oktatokorhaz Klinikai Onkologiai Osztaly"

location_facility: "Kursk Regional Clinical Oncology Dispensary General Oncology Department"

location_facility: Bacs-Kiskun Megyei Korhaz Onkoradiologiai Kozpont

location_facility: "Ordensklinikum Linz Barmherzige Schwestern Interne I"

location_facility: "Hospital A C Camargo Unidade de Pesquisa Clinica"

location_facility: "Centralny Szpital Kliniczny MSWiA Oddział Radioterapii i Onkologii"

location_facility: "INSTITUTO CATALAN DE ONCOLOGÍA - ICO Oncología Médica"

location_facility: "Hôpital Saint-Antoine Service d'Oncologie Médicale"

location_facility: "HOSPITAL 12 DE OCTUBRE Servicio Oncología Médica"

location_facility: "Magyar Honvedseg Egeszsegugyi Kozpont Onkologiai Osztaly"

location_facility: Lübecker Onkologische Schwerpunktpraxis im Hochschulstadttei

location_facility: "University Headache Clinic Outpatient oncology clinic"

location_facility: "Landeskrankenhaus (SALK) Universitätsklinik für Innere Medizin III (SALK)"

location_facility: "Onkologische Schwerpunktpraxis Kurfuerstendamm "

location_facility: "Odense Universitetshospital Department of Oncology"

summary: This study is designed as an international, open-label, controlled two-arm, randomized phase III comparison study evaluating the efficacy and safety of trifluridine/tipiracil in combination with bevacizumab versus trifluridine/tipiracil monotherapy in patients with refractory mCRC.


ipd_sharing: Undecided

acronym: SPRINTER

title: A Randomised, Double-blind, Placebo-controlled, Phase III Trial to Determine the Efficacy and Safety of Inhaled SNG001 for the Treatment of Patients Hospitalised Due to Moderate COVID-19

lead_sponsor: Synairgen Research Ltd.

location_country:
Brazil
Belgium
Portugal
Italy
Romania
Mexico
Netherlands
Argentina
Serbia
Spain
United Kingdom
United States
France
India
Israel
Colombia
Germany

location_facility: Fundación Santos y de la Garza Evia, I.B.P

location_facility: Clínica Sociedad Española de Beneficencia

location_facility: Hospital Militar Central Cirujano Mayor Dr. Cosme Argerich

location_facility: Bangalore Medical College and Research Institute

location_facility: Post Graduate Institute of Medical Education & Research, Chandigarh

location_facility: Sociedade Literaria e Caritativa Santo Agostinho

location_facility: Newcastle University - Institute of Cellular Medicine (ICM)

location_facility: Oriion Citicare Super Speciality Hospital - Intern

summary: The purpose of this Phase III study is to confirm that SNG001 can accelerate the recovery of hospitalised patients receiving oxygen with confirmed Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV-2). Safety and other efficacy endpoints will also be assessed.


title: A Multi-indication, Single-treatment Arm, Open-label Phase 2 Study of Regorafenib and Nivolumab in Combination in Patients With Recurrent or Metastatic Solid Tumors

lead_sponsor: Bayer

ipd_sharing_description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

location_country:
Taiwan
United Kingdom
Italy
Korea, Republic of
United States
France
Belgium
Japan

location_facility: Rocky Mountain Cancer Centers / Aurora, CO

location_facility: Severance Hospital, Yonsei University Health System

location_facility: H. Lee Moffitt Cancer Center & Research Institute

location_facility: University of Texas MD Anderson Cancer Center

location_facility: Institut Claudius Regaud - iUCT Oncopole

location_facility: Istituto Clinico Humanitas - Humanitas Mirasole S.p.A.

location_facility: Institut de Cancérologie de l'Ouest - Saint Herblain

location_facility: Baylor Charles A. Sammons Cancer Center at Dallas

location_facility: University Hospitals Coventry and Warwickshire NHS Trust

location_facility: Institut Bergonié - Unicancer Nouvelle Aquitaine

location_facility: ASST Grande Ospedale Metropolitano Niguarda

location_facility: Fondazione IRCCS Istituto Neurologico Carlo Besta

summary:
Researchers are looking for a better way to treat people with solid tumors. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.

In this trial, the researchers want to learn about regorafenib taken together with nivolumab in a small number of participants with different types of tumors. These include tumors in the head and neck, the esophagus, the pancreas, the brain, and the biliary tract. The biliary tract includes gall bladder and bile ducts.

The trial will include about 200 participants who are at least 18 years old. All of the participants will take 90 mg of regorafenib as a tablet by mouth. The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment. All of the participants will receive 480 milligrams (mg) of nivolumab through a needle put into a vein (IV infusion).

The participants will take treatments in 4-week periods called cycles. They will take regorafenib once a day for 3 weeks, then stop for 1 week. In each cycle, the participants will receive nivolumab one time. These 4-week cycles will be repeated throughout the trial. The participants can take nivolumab and regorafenib until their cancer gets worse, until they have medical problems, or until they leave the trial. The longest nivolumab can be given is up to 2 years.

During the trial, the doctors will take pictures of the participants' tumors using CT or MRI and will take blood and urine samples. The doctors will also do physical examinations and check the participants' heart health using an electrocardiogram (ECG). They will ask questions about how the participants are feeling and if they have any medical problems.


title: PSMAfore: A Phase III, Open-label, Multi-Center, Randomized Study Comparing 177Lu-PSMA-617 vs. a Change of Androgen Receptor-directed Therapy in the Treatment of Taxane Naïve Men With Progressive Metastatic Castrate Resistant Prostate Cancer

acronym: PSMAfore

summary:
The purpose of this study is to determine whether 177Lu-PSMA-617 improves the rPFS or death compared to a change in ARDT in mCRPC participants that were previously treated with an alternate ARDT and not exposed to a taxane-containing regimen in the CRPC or mHSPC settings.

Approximately 450 participants will be randomized (225 per treatment group).

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

lead_sponsor: Novartis Pharmaceuticals

location_country:
Poland
Spain
United Kingdom
Austria
Netherlands
Canada
Switzerland
Sweden
United States
France
Belgium
Germany
Slovakia
Czechia

location_facility: Tulane University Health Sciences Center

location_facility: Nebraska Cancer Specialists Oncology Hematology West

location_facility: Beth Israel Deaconess Medical Center Dept. of BIDMC

location_facility: Virginia Oncology Associates VOA - Lake Wright

location_facility: Mount Sinai Hospital School of Medicine Tisch Cancer Institute

location_facility: The Ohio State University Comprehensive Cancer Center PulmonaryClinicalTrialsOffice

location_facility: Duke University Medical Center Morris Building

location_facility: Rocky Mountain Cancer Centers RMCC - Aurora

location_facility: Oncology Hematology Associates of Southeast Virginia Roanoke Loc

location_facility: NYU Laura and Isaac Perlmutter Cancer Center NYU Langone Medical Center

location_facility: University of Florida College of Medicine x

location_facility: Washington University School of Medicine Siteman Cancer Center

location_facility: Dana-Farber Cancer Institute Dana-Farber Cancer Institute_

location_facility: Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering CC