title: A Multicenter Phase II Clinical Trial of Lurbinectedin (PM01183) in Selected Advanced Solid Tumors

summary: Multicenter, open-label, exploratory, phase II clinical trial to evaluate the efficacy and safety of PM01183 in previously treated patients with advanced solid tumors

ReferenceCitation: Boni V, Pistilli B, Braña I, Shapiro GI, Trigo J, Moreno V, Castellano D, Fernández C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Longo F, Zaman K, Antón A, Paredes A, Huidobro G, Subbiah V. Lurbinectedin, a selective inhibitor of oncogenic transcription, in patients with pretreated germline BRCA1/2 metastatic breast cancer: results from a phase II basket study. ESMO Open. 2022 Oct;7(5):100571. doi: 10.1016/j.esmoop.2022.100571. Epub 2022 Aug 28.

ReferenceCitation: Longo-Muñoz F, Castellano D, Alexandre J, Chawla SP, Fernández C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Moreno V, Sanz-García E, Awada A, Santaballa A, Subbiah V. Lurbinectedin in patients with pretreated neuroendocrine tumours: Results from a phase II basket study. Eur J Cancer. 2022 Sep;172:340-348. doi: 10.1016/j.ejca.2022.06.024. Epub 2022 Jul 10.

ReferenceCitation: Subbiah V, Braña I, Longhi A, Boni V, Delord JP, Awada A, Boudou-Rouquette P, Sarantopoulos J, Shapiro GI, Elias A, Ratan R, Fernandez C, Kahatt C, Cullell-Young M, Siguero M, Zeaiter A, Chawla SP. Antitumor Activity of Lurbinectedin, a Selective Inhibitor of Oncogene Transcription, in Patients with Relapsed Ewing Sarcoma: Results of a Basket Phase II Study. Clin Cancer Res. 2022 Jul 1;28(13):2762-2770. doi: 10.1158/1078-0432.CCR-22-0696.

ReferenceCitation: Fernández-Teruel C, Fudio S, Lubomirov R. Integrated exposure-response analysis of efficacy and safety of lurbinectedin to support the dose regimen in small-cell lung cancer. Cancer Chemother Pharmacol. 2022 May;89(5):585-594. doi: 10.1007/s00280-021-04366-3. Epub 2021 Nov 5.

ReferenceCitation: Subbiah V, Paz-Ares L, Besse B, Moreno V, Peters S, Sala MA, López-Vilariño JA, Fernández C, Kahatt C, Alfaro V, Siguero M, Zeaiter A, Zaman K, López R, Ponce S, Boni V, Arrondeau J, Delord JP, Martínez M, Wannesson L, Antón A, Valdivia J, Awada A, Kristeleit R, Olmedo ME, Rubio MJ, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D' Arcangelo M, Santoro A, Villalobos VM, Sands J, Trigo J. Antitumor activity of lurbinectedin in second-line small cell lung cancer patients who are candidates for re-challenge with the first-line treatment. Lung Cancer. 2020 Dec;150:90-96. doi: 10.1016/j.lungcan.2020.10.003. Epub 2020 Oct 10.

ReferenceCitation: Trigo J, Subbiah V, Besse B, Moreno V, López R, Sala MA, Peters S, Ponce S, Fernández C, Alfaro V, Gómez J, Kahatt C, Zeaiter A, Zaman K, Boni V, Arrondeau J, Martínez M, Delord JP, Awada A, Kristeleit R, Olmedo ME, Wannesson L, Valdivia J, Rubio MJ, Anton A, Sarantopoulos J, Chawla SP, Mosquera-Martinez J, D'Arcangelo M, Santoro A, Villalobos VM, Sands J, Paz-Ares L. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020 May;21(5):645-654. doi: 10.1016/S1470-2045(20)30068-1. Epub 2020 Mar 27. Erratum in: Lancet Oncol. 2020 Dec;21(12):e553.

lead_sponsor: PharmaMar

location_country:
Spain
Italy
United Kingdom
Switzerland
Sweden
United States
France
Belgium
Germany

location_facility: Hospital Universitario Puerta de Hierro Majadahonda

location_facility: Hospital Universitario Virgen de las Nieves

location_facility: Institute for Drug Development, Cancer Therapy & Research Center at University of Texas Health Science Center

location_facility: Complexo Hospitalario Universitario A Coruña

location_facility: Istituto Oncologico della Svizzera Italiana (IOSI)

location_facility: Complejo Hospitalario de Especialidades Virgen de la Victoria

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: Hopsital Universitario Donostia - Donostia Unibertsitate Ospitalea

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Hospital Universitari i Polotècnic la Fe

location_facility: Charité Universitätsmedizin Berlin - Campus Benjamin Franklin - Comprehensive Cancer Center

location_facility: Hospital Universitario Central de Asturias

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: AUSL Romagna - Ospedale Santa Maria delle Croci

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Complejo Hospitalario Regional Reina Sofía

location_facility: ASST Monza - Ospedale San Gerardo di Monza Struttura Complessa di Oncologia Medica

location_facility: Complexo Hospitalario Universitario de Santiago


ipd_sharing: Yes

status: Completed

primary_purpose: Treatment

intervention_type: Drug

title: A Randomized Phase 2 Study of Abemaciclib (LY2835219) Versus Docetaxel in Patients With Stage IV Squamous Non-Small Cell Lung Cancer Previously Treated With Platinum-Based Chemotherapy

study_completion_date_type: Actual

lead_sponsor: Eli Lilly and Company

type: Other Identifier

type: EudraCT Number

source: euctr

design_allocation: Randomized

study_start_date_type: Actual

study_type: Interventional

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.

enrollment_type: Actual

location_country:
Poland
Taiwan
Spain
Italy
Russian Federation
Australia
Ukraine
Hungary
Korea, Republic of
United States
France
Romania
Germany

location_facility: Volgograd regional clinical oncology dispensary

location_facility: Washington University School of Medicine

location_facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

location_facility: St-Petersburg scientifical practical center of specialized kinds of medical care (oncological)

summary: The main purpose of this study is to evaluate the effectiveness of the study drug known as abemaciclib versus docetaxel in participants with stage IV squamous non-small cell lung cancer (NSCLC) previously treated with platinum-based chemotherapy.

lead_sponsor_type: industriel

status_simplified: Completed


title: A Phase 3, Multicenter, Long Term, Extension Study of the Safety and Efficacy of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide [d6-DM]/Quinidine Sulfate [Q]) for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type

summary: This is an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305, which also allows participants from the Phase 2 Study 12-AVR-131 to be included.

status: Recruiting

study_completion_date_type: Anticipated

design_allocation: Non-Randomized

enrollment_type: Anticipated

ipd_sharing_description: Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.

lead_sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

location_country:
Poland
Spain
Italy
Canada
Hungary
United States
France
South Africa
Bulgaria
Czechia

location_facility: Pszichiatriai es Pszichiatriai Rehabilitacios Osztaly

location_facility: Centre Hospitalier Universitaire Dijon Bourgogn

location_facility: The Birches at Newton / Family Medical Associates

location_facility: Fondazione Santa Lucia - Istituto di Ricovero e Cura a Carattere Scientifico

location_facility: Alzheimer's Research and Treatment Center #2

location_facility: Medical Research & Health Education Foundation, Inc.

location_facility: Nathan S. Kline Institute for Psychiatric Research #1

location_facility: ANI Neurology PLLC dba Alzheimer's Memory Center

location_facility: Houston Methodist Neurological Institute

location_facility: Dr. Kenessey Albert Kórház-Rendelőintézet

location_facility: University Texas Southwestern Medical Center

location_facility: Pharmaceuticals Research Associates, Inc.

location_facility: Texas Medical Research Associates, L.L.C.

location_facility: Columbus Research & Wellness Institute, INC

location_facility: Michigan State University Department of Neurology

location_facility: Clinical Neuroscience Research Associates, Inc. dba The Memory Clinic

location_facility: University Multiprofile Hospital for Active Treatment Alexandrovska

location_facility: New Foundation Medical Group Clinical Trials

location_facility: Flora Baker Center for Alzheimer's Disease and Related Disorders

location_facility: Collaborative Neuroscience Network, LLC.

location_facility: Lytle and Weiss, PLLC dba Clinical Trials of the Rockies

location_facility: Alzheimer's Research and Treatment Center #3

location_facility: Clinical Research Associates of South Florida #1

location_facility: MidAmerica Neuroscience Research Foundation

location_facility: Rhode Island Mood & Memory Research Institute

location_facility: Neurology Research Institute Palm Beach, LLC #2

location_facility: Nathan S. Kline Institute for Psychiatric Research #2

location_facility: Premier Clinical Research Institute, Inc. #1

location_facility: Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord

location_facility: Cleveland Clinic Lou Ruvo Center for Brain Health at Lakewood Hospital

location_facility: Alzheimer's Research and Treatment Center #1

location_facility: Neurology Research Institute Palm Beach, LLC #1

location_facility: Alliance for Wellness, Inc dba Alliance for Research

location_facility: Josephson Wallack Munshower Neurology, PC

location_facility: Eastside Comprehensive Medical Center, LLC

location_facility: Centre Hospitalier Universitaire Toulouse - Casselardit Ancely

location_facility: Debreceni Egyetem Kenezy Gyula Egyetemi Korhaz

location_facility: Veteran Affairs Medical Center, Salem Virginia

location_facility: Research Center for Clinical Studies, Inc.

location_facility: Complejo Asistencial de Zamora Hospital Virgen de la Concha

location_facility: Premier Clinical Research Institute, Inc. #2

location_facility: Neurology and Neuroscience Associates, Inc.

location_facility: Miami Dade Medical Research Institute, LLC

location_facility: Clinical Research Associates of South Florida #2

location_facility: Wielospecjalistyczna Poradnia Lekarska Synapsis

location_facility: Psychiatry and Alzheimer's Care of Rochester, PLLC

location_facility: The Samuel & Alexia Bratton Memory Clinic

location_facility: Alexian Brothers Neurosciences Institute

status_simplified: Ongoing


title: Long Term Follow-Up of Patients Exposed to Lentiviral-Based CAR T-Cell Therapy

acronym: PAVO

summary: Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is required. The purpose of this study is to monitor all patients exposed to CAR-T therapied for 15 years following their last CAR-T (e.g. CTL019) infusion to assess the risk of delayed adverse events (AEs), monitor for replication competent lentivirus (RCL) and assess long-term efficacy, including vector persistence.

primary_purpose: Other

lead_sponsor: Novartis Pharmaceuticals

location_country:
Denmark
Taiwan
Spain
Italy
Austria
Australia
Netherlands
Canada
Finland
United Kingdom
United States
France
Singapore
Norway
Belgium
Japan
Germany

location_facility: The Childrens Hospital of Philadelphia CHOP

location_facility: University of Utah Clinical Trials Office

location_facility: Mayo Clinic Arizona Mayo Clinic Building

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Stanford Universtiy Medical Center SC - CTL019B2205J - B2206

location_facility: University of Wisconsin Hospital and Clinics

location_facility: Childrens Hospital Los Angeles SC CTL019

location_facility: Duke Unversity Medical Center SC - CTL019B2205J

location_facility: University of Chicago Medical Center, Hematology & Oncology

location_facility: Children's Healthcare of Atlanta SC CTL019

location_facility: University of Michigan Health System SC CTL019

location_facility: Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State Univ.

location_facility: Emory University School of Medicine/Winship Cancer Institute

intervention_type: Genetic


status: Terminated

intervention_type: Biological

title: Prospective, Phase II/III, Randomized Clinical Study to Compare BEGEDINA® Versus "Conventional Treatment" for Treating Steroid Resistant Acute Graft-versus Host Disease

lead_sponsor: Adienne SA

location_country:
Spain
Italy
United Kingdom
Switzerland
United States
France
Germany

location_facility: Washington University School of Medicine

location_facility: University Hospital Southampton NHS Foundation Trust

location_facility: City of Hope Comprehensive Cancer Center

location_facility: Centre Hospitalier Universitaire de Grenoble

location_facility: Policlinico Universitario Agostino Gemelli

location_facility: University of Kansas Cancer Center and Medical Pavilion

location_facility: Ospedale Casa Sollievo della Sofferenza, IRCCS

location_facility: Huntsman Cancer Center, University of Utah

location_facility: Policlinico S.Orsola Malpighi, AOU di Bologna

location_facility: A.O. Universitaria Policlinico Tor Vergata

location_facility: Hackensack University Medical Center - John Theurer Cancer Center

location_facility: Hospital Saint-Louis APHP (Hôpitaux Universitaires Sant-Louis)

summary: The objectives of this study are to determine the efficacy and safety of BEGEDINA® in subjects with steroid resistant acute graft versus host disease (GvHD). GvHD is a rare and complex immunological disease occurring in some recipients of allogeneic hematopoietic stem cell transplants (HSCTs) and affecting principally the skin, liver and gastrointestinal (GI) tissues. The disease is life threatening and may be acute or chronic and the first choice treatment for patients with acute GvHD (Grade II or higher) is the immunosuppressive corticosteroid hormone methylprednisolone. However, some GvHD patients may be resistant to this treatment leading to disease progression and a high rate of morbidity and mortality, primarily from infections and/or multi-organ failure. There are currently no other satisfactory therapies. BEGEDINA® is a therapeutic monoclonal antibody that recognises and binds to CD26 on CD4+ T lymphocytes. BEGEDINA® reduces the activity of CD26 in these cells and inhibits the immune response leading to improvement in patients that have shown steroid resistance. This study is therefore aimed at demonstrating that BEGEDINA® is a safe and effective treatment for steroid-resistant GvHD patients where no other such treatments are currently available.

status_simplified: Unknown


title: A Phase III, Open-Label, Randomized Study of Atezolizumab (Anti-PD-L1 Antibody) Compared With Gemcitabine+Cisplatin or Carboplatin for PD-L1-Selected, Chemotherapy Naive Patients With Stage IV Squamous Non-Small Cell Lung Cancer

lead_sponsor: Hoffmann-La Roche

location_country:
Poland
Serbia
Spain
Greece
Italy
Russian Federation
United Kingdom
Hungary
Korea, Republic of
United States
France
Romania
Germany
Czechia

location_facility: Szabolcs-Szatmar-Bereg Megyei; Korhazak es Egyetemi Oktatokorhaz

location_facility: Azienda Ospedaliera Istituti Ospitalieri

location_facility: Teo Health SA - Saint Constantin Hospital

location_facility: IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola; Oncologia Medica

location_facility: Clinical Hospital Center Bezanijska kosa; Clinic for Oncology

location_facility: Penn State Milton S. Hershey Medical Center

location_facility: Chonnam National University Hwasun Hospital

location_facility: Clin Hospital Center - Kragujevac; Pulmonary Diseases

location_facility: Fundacion Investigacion Hospital La Fe de Valencia

location_facility: Irccs Istituto Nazionale Dei Tumori (Int);S.C. Medicina Oncologica 2

location_facility: Kursk Regional Clinical Oncology Dispensary

location_facility: California Cancer Associates for Research & Excellence, Inc.

location_facility: University of Pecs, I st Dept of Internal Medicine

location_facility: Irccs Centro Di Riferimento Oncologico (CRO)

location_facility: Carolina Oncology Specialists, PA - Hickory

location_facility: Sibiu Emergency Clinical County Hospital

location_facility: A.O.U.I. VERONA-OSPEDALE BORGO TRENTO; ONCOLODIA MEDICA-d.O.

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

location_facility: Georgios Papanikolaou General Hosp. of Thessaloniki

location_facility: The Catholic University of Korea St. Vincent's Hospital

location_facility: Dr Constantin Opris Emergency County Hospital Baia Mare

location_facility: Filial #1 Regional Oncology Dispensary of Nizhniy Novgorod

location_facility: Arkhangelsk Regional Clinical Oncology Dispensary

location_facility: MultiCare Regional Cancer Center - Auburn

location_facility: Chao Family Comprehensive Cancer Center; UC Irvine Medical Center

location_facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rend.Int.

location_facility: Hospital Universitari Germans Trias i Pujol; Servicio de Oncologia

location_facility: Eastern Connecticut Hematology and Oncology Associates; (ECHO)

location_facility: Seoul National University Bundang Hospital

location_facility: Institutul Regional de Oncologie Iasi; Clinica de Hematologie

summary: This randomized, open-label study was designed to evaluate and compare the safety and efficacy of atezolizumab with gemcitabine + cisplatin or carboplatin in PD-L1 selected participants with chemotherapy-naive, Stage IV squamous NSCLC. The study was closed due to low patient enrollment and the Sponsor's decision to include patients with squamous NSCLC into the GO29431 study, NCT02409342. Therefore the planned objectives of this study are no longer applicable and formal analyses of efficacy or safety have not been performed.


status: Active, not recruiting

acronym: VALUE

title: An Open-label, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Lacosamide as Adjunctive Therapy for Uncontrolled Primary Generalized Tonic-Clonic Seizures in Subjects With Idiopathic Generalized Epilepsy

lead_sponsor: UCB BIOSCIENCES, Inc.

ipd_sharing_description: Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.

location_country:
Spain
Italy
United States
Romania
Japan
Czechia
Poland
Portugal
Russian Federation
Australia
Israel
Mexico
Slovakia
Brazil
Hungary
China
Germany
Bulgaria
Taiwan
Korea, Republic of
France

summary: Assessment of long-term safety and efficacy of oral lacosamide (LCM) as an adjunctive therapy for uncontrolled primary generalized tonic-clonic seizures (PGTCS) in subjects >= 4 years of age with idiopathic generalized epilepsy (IGE). This study will enroll subjects from the LCM SP0982 [NCT02408523] study.


title: Open Label Multicenter Phase I/II Study of the Safety and Efficacy of PDR001 Administered to Patients With Advanced Malignancies

ReferenceType: derived

ReferenceCitation: Capdevila J, Wirth LJ, Ernst T, Ponce Aix S, Lin CC, Ramlau R, Butler MO, Delord JP, Gelderblom H, Ascierto PA, Fasolo A, Führer D, Hütter-Krönke ML, Forde PM, Wrona A, Santoro A, Sadow PM, Szpakowski S, Wu H, Bostel G, Faris J, Cameron S, Varga A, Taylor M. PD-1 Blockade in Anaplastic Thyroid Carcinoma. J Clin Oncol. 2020 Aug 10;38(23):2620-2627. doi: 10.1200/JCO.19.02727. Epub 2020 May 4.

ReferenceCitation: Naing A, Gainor JF, Gelderblom H, Forde PM, Butler MO, Lin CC, Sharma S, Ochoa de Olza M, Varga A, Taylor M, Schellens JHM, Wu H, Sun H, Silva AP, Faris J, Mataraza J, Cameron S, Bauer TM. A first-in-human phase 1 dose escalation study of spartalizumab (PDR001), an anti-PD-1 antibody, in patients with advanced solid tumors. J Immunother Cancer. 2020 Mar;8(1). pii: e000530. doi: 10.1136/jitc-2020-000530.

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

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

location_country:
Poland
Taiwan
Spain
Italy
Lebanon
Netherlands
Canada
Thailand
Hungary
United States
France
Turkey
Norway
Germany

location_facility: Huntsman Cancer Institute Univ. of Utah HCI

location_facility: The Sidney Kimmel Cancer Center at Johns Hopkins Hospital Johns Hopkins

location_facility: Oregon Health and Science University SC-10

location_facility: University of Texas MD Anderson Cancer Center MD Anderson PSC

summary:
The purpose of this "first-in-human" study of PDR001 was to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of PDR001 administered i.v. as a single agent to adult patients with solid tumors.

By blocking the interaction between PD-1 and its ligands, PD-L1 and PD-L2, PDR001 inhibits the PD-1 immune checkpoint, resulting in activation of an antitumor immune response by activating effector T-cells and inhibiting regulatory T-cells.


title: A Phase 1a/1b Multicenter, Single-Arm, Open-Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Preliminary Activity of Oral ACY-241 Alone and in Combination With Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed or Relapsed-and-Refractory Multiple Myeloma

summary: This is a phase 1a/1b, multicenter, single-arm, open-label, dose escalation study to determine the maximum tolerated dose (MTD) and evaluate the safety and preliminary antitumor activity of ACY-241 for oral administration as monotherapy and in combination therapy with orally administered pomalidomide and low-dose dexamethasone in eligible patients with relapsed or relapsed-and-refractory multiple myeloma (MM).

lead_sponsor: Celgene

location_country:
Spain
Greece
United States
France
Germany

location_facility: Universitatsklinikum Heidelberg Medizinische Klinik Krehl-Klinik Haematologie, Onkologie, Rheumato

location_facility: CTRC at The UT Health Science Center at San Antonio

location_facility: CHRU de Lille-Hopital Claude Huriez Service des Maladies du Sang

location_facility: Alexandra Hospital, University of Athens

location_facility: Winship Cancer Institute of Emory University


title: A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients With Epidermolysis Bullosa

summary: The aim was to assess the efficacy and safety of SD-101-6.0 cream versus Placebo (SD-101-0.0) cream in the treatment of skin lesions in participants with Epidermolysis Bullosa. Funding Source - United States Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD).

ReferenceCitation: Murrell DF, Paller AS, Bodemer C, Browning J, Nikolic M, Barth JA, Lagast H, Krusinska E, Reha A; ESSENCE Study Group. Wound closure in epidermolysis bullosa: data from the vehicle arm of the phase 3 ESSENCE Study. Orphanet J Rare Dis. 2020 Jul 21;15(1):190. doi: 10.1186/s13023-020-01435-3.

ReferenceCitation: Paller AS, Browning J, Nikolic M, Bodemer C, Murrell DF, Lenon W, Krusinska E, Reha A, Lagast H, Barth JA; ESSENCE Study Group. Efficacy and tolerability of the investigational topical cream SD-101 (6% allantoin) in patients with epidermolysis bullosa: a phase 3, randomized, double-blind, vehicle-controlled trial (ESSENCE study). Orphanet J Rare Dis. 2020 Jun 23;15(1):158. doi: 10.1186/s13023-020-01419-3.

lead_sponsor: Scioderm, Inc.

location_country:
Poland
Serbia
Spain
Italy
Austria
Australia
Netherlands
Lithuania
United Kingdom
United States
France
Israel
Germany


title: A Twelve-Week, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Obstructive Sleep Apnea (OSA)

acronym: OSA

summary: This trial is a 12 week, randomized, double-blind, placebo controlled, multicenter, 5-arm parallel group study of safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with OSA.

ReferenceCitation: Rosenberg R, Thorpy MJ, Dauvilliers Y, Schweitzer PK, Zammit G, Gotfried M, Bujanover S, Scheckner B, Malhotra A. Incidence and duration of common early-onset adverse events in randomized controlled trials of solriamfetol for treatment of excessive daytime sleepiness in obstructive sleep apnea and narcolepsy. J Clin Sleep Med. 2022 Jan 1;18(1):235-244. doi: 10.5664/jcsm.9550.

ReferenceCitation: Schweitzer PK, Mayer G, Rosenberg R, Malhotra A, Zammit GK, Gotfried M, Chandler P, Baladi M, Strohl KP. Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in OSA: An Analysis of Subgroups Adherent or Nonadherent to OSA Treatment. Chest. 2021 Jul;160(1):307-318. doi: 10.1016/j.chest.2021.02.033. Epub 2021 Feb 22.

ReferenceCitation: Weaver TE, Menno DM, Bron M, Crosby RD, Morris S, Mathias SD. Determination of thresholds for minimally important difference and clinically important response on the functional outcomes of sleep questionnaire short version in adults with narcolepsy or obstructive sleep apnea. Sleep Breath. 2021 Sep;25(3):1707-1715. doi: 10.1007/s11325-020-02270-3. Epub 2021 Jan 4.

ReferenceCitation: Rosenberg R, Baladi M, Bron M. Clinically relevant effects of solriamfetol on excessive daytime sleepiness: a posthoc analysis of the magnitude of change in clinical trials in adults with narcolepsy or obstructive sleep apnea. J Clin Sleep Med. 2021 Apr 1;17(4):711-717. doi: 10.5664/jcsm.9006. Erratum in: J Clin Sleep Med. 2021 Nov 1;17(11):2343.

ReferenceCitation: Weaver TE, Drake CL, Benes H, Stern T, Maynard J, Thein SG, Andry JM Sr, Hudson JD, Chen D, Carter LP, Bron M, Lee L, Black J, Bogan RK. Effects of Solriamfetol on Quality-of-Life Measures from a 12-Week Phase 3 Randomized Controlled Trial. Ann Am Thorac Soc. 2020 Aug;17(8):998-1007. doi: 10.1513/AnnalsATS.202002-136OC.

ReferenceCitation: Schweitzer PK, Rosenberg R, Zammit GK, Gotfried M, Chen D, Carter LP, Wang H, Lu Y, Black J, Malhotra A, Strohl KP; TONES 3 Study Investigators. Solriamfetol for Excessive Sleepiness in Obstructive Sleep Apnea (TONES 3). A Randomized Controlled Trial. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1421-1431. doi: 10.1164/rccm.201806-1100OC.

lead_sponsor: Jazz Pharmaceuticals

location_country:
Netherlands
Canada
United States
France
Germany

location_facility: Southwest Cleveland Sleep Research Center

location_facility: Somni bene GmbH Institut für Medizinische Forschung und Schlafmedizin Schwerin GmbH

location_facility: University of Illinois at Chicago College of Nursing

location_facility: So Cal Institute For Respiratory Diseases, Inc.

location_facility: medbo Bezirksklinikum Regensburg Schlafmedizinisches Zentrum

location_facility: Mercy St. Anne & Mercy St. Charles Sleep Disorders Center

location_facility: Clinical Research Group of St. Petersburg

location_facility: Henry Ford Hospital Sleep Disorders & Research Center

location_facility: Sleep Medicine & Research Center, St. Luke's Hospital

location_facility: Hickory Research Center, ARSM Research, LLC

location_facility: Ohio Sleep Medicine & Neuroscience Institute

location_facility: Stanford University Center for Narcolepsy

location_facility: Universitätsklinikum Münster Department für Neurologie

location_facility: Northwestern University Feinberg School of Medicine


title: A Twelve-week, Double-blind, Placebo-controlled, Randomized, Parallel-group, Multicenter Study of the Safety and Efficacy of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy

ReferenceCitation: Dauvilliers Y, Shapiro C, Mayer G, Lammers GJ, Emsellem H, Plazzi G, Chen D, Carter LP, Lee L, Black J, Thorpy MJ. Solriamfetol for the Treatment of Excessive Daytime Sleepiness in Participants with Narcolepsy with and without Cataplexy: Subgroup Analysis of Efficacy and Safety Data by Cataplexy Status in a Randomized Controlled Trial. CNS Drugs. 2020 Jul;34(7):773-784. doi: 10.1007/s40263-020-00744-2.

ReferenceCitation: Emsellem HA, Thorpy MJ, Lammers GJ, Shapiro CM, Mayer G, Plazzi G, Chen D, Carter LP, Villa KF, Lee L, Menno D, Black J, Dauvilliers Y. Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy. Sleep Med. 2020 Mar;67:128-136. doi: 10.1016/j.sleep.2019.11.1250. Epub 2019 Dec 4.

location_country:
Netherlands
Finland
Canada
United States
France
Germany

location_facility: Northwestern University, Feinberg School of Medicine

location_facility: Critical Care Pulmonary & Sleep Associates, LLC

location_facility: University of Illinois Chicago, College of Nursing

summary: This trial is a 12-week, randomized, double-blind, placebo controlled, multicenter, 4-treatment parallel group study of the safety and efficacy of JZP-110 in the treatment of excessive sleepiness in adult subjects with narcolepsy.


title: A Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-C19 in Adults With Refractory Aggressive Non-Hodgkin Lymphoma

lead_sponsor: Kite, A Gilead Company

publications_result: Topp MS, van Meerten T, Wermke M et al. Preliminary Results of Earlier Steroid Use with Axicabtagene Ciloleucel in Patients With Relapsed/Refractory Large B Cell Lymphoma. Poster presented at the American Society of Presented at: American Society of Clinical Oncology Annual Meeting. May 31-June 4, 2019; Chicago, Illinois; Abstract 7558.

ReferenceType: result

ReferenceCitation: Topp, M, van Meerten T, Houot R, et al. (2019). Earlier Steroid Use with Axicabtagene Ciloleucel (Axi-Cel) in Patients with Relapsed/Refractory Large B Cell Lymphoma. Blood (ASH Annual Meeting Abstracts) 134(Suppl 1): 243. Abstract 626.

ReferenceCitation: Abstract: Oluwole OO, et al. Prophylactic corticosteroid use with axicabtagene ciloleucel in patients with relapsed/refractory large B-cell lymphoma. Transplantation and Cellular Therapy 2021.

ReferenceCitation: Oluwole OO, Bouabdallah K, Munoz J, De Guibert S, Vose JM, Bartlett NL, Lin Y, Deol A, McSweeney PA, Goy AH, Kersten MJ, Jacobson CA, Farooq U, Minnema MC, Thieblemont C, Timmerman JM, Stiff P, Avivi I, Tzachanis D, Kim JJ, Bashir Z, McLeroy J, Zheng Y, Rossi JM, Johnson L, Goyal L, van Meerten T. Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma. Br J Haematol. 2021 Aug;194(4):690-700. doi: 10.1111/bjh.17527. Epub 2021 Jul 22.

ReferenceCitation: Santa Monica, Calif. New Four-Year Data Show Long-Term Survival in Patients With Large B-Cell Lymphoma Treated With Yescarta® in ZUMA-1 Trial. Data presented at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. December 5, 2020; Abstract 1187

ReferenceCitation: Max S. Topp, Tom van Meerten, Martin Wermke, Pieternella J. Lugtenburg, Monique C. Minnema, Kevin W. Song, Catherine Thieblemont, Yizhou Jiang, Vicki Plaks, Anne Kerber, Marie José Kersten. Preliminary Results of Earlier Steroid Use With Axicabtagene Ciloleucel in Patients With Relapsed/ Refractory Large B Cell Lymphoma. Poster presented at ASCO 2019 Annual Meeting. June 3, 2019; Abstract 7558

ReferenceCitation: Sattva S. Neelapu, Caron A. Jacobson, Olalekan O. Oluwole, Javier Munoz, Abhinav Deol, David B. Miklos, Nancy L. Bartlett, Ira Braunschweig, Yizhou Jiang, Jenny J. Kim, Lianqing Zheng, John M. Rossi, Frederick L. Locke. Axicabtagene Ciloleucel (Axi-Cel) In Refractory Large B Cell Lymphoma: Outcomes in Patients ≥ or < 65 Years of Age in the Pivotal Phase 1/2 ZUMA-1 Study. Poster presented at EHA 2019. June 15, 2019; Abstract 1066

ReferenceCitation: Max S. Topp, Tom van Meerten, Martin Wermke, Pieternella J. Lugtenburg, Monique C. Minnema, Kevin W. Song, Catherine Thieblemont, Yizhou Jiang, Vicki Plaks, Anne Kerber, Marie José Kersten. Axicabtagene Ciloleucel (Axi-Cel) in Patients With Relapsed/Refractory Large B Cell Lymphoma: Preliminary Results of Earlier Steroid Use. Poster presented at EHA 2019. June 15, 2019; Abstract 1067

ReferenceCitation: Sattva S. Neelapu, John M. Rossi, Caron A. Jacobson, Frederick L. Locke, David B. Miklos, Patrick M. Reagan, Scott Rodig, Lazaros J. Lekakis, Ian W. Flinn, Lianqing Zheng, Francesca Milletti, Edmund Chang, Allen Xue, Vicki Plaks, Jenny J. Kim, Adrian Bot. CD19-Loss With Preservation of Other B Cell Lineage Features in Patients With Large B Cell Lymphoma Who Relapsed Post-Axi-Cel. Blood (ASH Annual Meeting Abstracts) 134(Suppl 1): 203. Abstract 704.

ReferenceCitation: Sattva S. Neelapu, Frederick L. Locke, Nancy L. Bartlett, Lazaros J. Lekakis, Patrick Reagan, David B. Miklos, Caron A. Jacobson, Ira Braunschweig, Olalekan Oluwole, Tanya Siddiqi, Yi Lin, Michael Crump, John Kuruvilla, Eric Van Den Neste, Umar Farooq, Lynn Navale, Venita DePuy, Jenny J. Kim, Christian Gisselbrecht. A Comparison of Two-Year Outcomes in ZUMA-1 (Axicabtagene Ciloleucel) and SCHOLAR-1 in Patients With Refractory Large B Cell Lymphoma. Blood (ASH Annual Meeting Abstracts) 134(Suppl 1): 4095. Abstract 626.

ReferenceCitation: Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9:CD013365. doi: 10.1002/14651858.CD013365.pub2. Review.

ReferenceCitation: Maloney DG, Kuruvilla J, Liu FF, Kostic A, Kim Y, Bonner A, Zhang Y, Fox CP, Cartron G. Matching-adjusted indirect treatment comparison of liso-cel versus axi-cel in relapsed or refractory large B cell lymphoma. J Hematol Oncol. 2021 Sep 8;14(1):140. doi: 10.1186/s13045-021-01144-9.

ReferenceCitation: Westin JR, Kersten MJ, Salles G, Abramson JS, Schuster SJ, Locke FL, Andreadis C. Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: Observations from the JULIET, ZUMA-1, and TRANSCEND trials. Am J Hematol. 2021 Oct 1;96(10):1295-1312. doi: 10.1002/ajh.26301. Epub 2021 Aug 13. Review.

ReferenceCitation: Upadhyay R, Boiarsky JA, Pantsulaia G, Svensson-Arvelund J, Lin MJ, Wroblewska A, Bhalla S, Scholler N, Bot A, Rossi JM, Sadek N, Parekh S, Lagana A, Baccarini A, Merad M, Brown BD, Brody JD. A Critical Role for Fas-Mediated Off-Target Tumor Killing in T-cell Immunotherapy. Cancer Discov. 2021 Mar;11(3):599-613. doi: 10.1158/2159-8290.CD-20-0756. Epub 2020 Dec 17.

ReferenceCitation: Locke FL, Rossi JM, Neelapu SS, Jacobson CA, Miklos DB, Ghobadi A, Oluwole OO, Reagan PM, Lekakis LJ, Lin Y, Sherman M, Better M, Go WY, Wiezorek JS, Xue A, Bot A. Tumor burden, inflammation, and product attributes determine outcomes of axicabtagene ciloleucel in large B-cell lymphoma. Blood Adv. 2020 Oct 13;4(19):4898-4911. doi: 10.1182/bloodadvances.2020002394.

ReferenceCitation: Locke FL, Ghobadi A, Jacobson CA, Miklos DB, Lekakis LJ, Oluwole OO, Lin Y, Braunschweig I, Hill BT, Timmerman JM, Deol A, Reagan PM, Stiff P, Flinn IW, Farooq U, Goy A, McSweeney PA, Munoz J, Siddiqi T, Chavez JC, Herrera AF, Bartlett NL, Wiezorek JS, Navale L, Xue A, Jiang Y, Bot A, Rossi JM, Kim JJ, Go WY, Neelapu SS. Long-term safety and activity of axicabtagene ciloleucel in refractory large B-cell lymphoma (ZUMA-1): a single-arm, multicentre, phase 1-2 trial. Lancet Oncol. 2019 Jan;20(1):31-42. doi: 10.1016/S1470-2045(18)30864-7. Epub 2018 Dec 2.

ReferenceCitation: Neelapu SS, Locke FL, Bartlett NL, Lekakis LJ, Miklos DB, Jacobson CA, Braunschweig I, Oluwole OO, Siddiqi T, Lin Y, Timmerman JM, Stiff PJ, Friedberg JW, Flinn IW, Goy A, Hill BT, Smith MR, Deol A, Farooq U, McSweeney P, Munoz J, Avivi I, Castro JE, Westin JR, Chavez JC, Ghobadi A, Komanduri KV, Levy R, Jacobsen ED, Witzig TE, Reagan P, Bot A, Rossi J, Navale L, Jiang Y, Aycock J, Elias M, Chang D, Wiezorek J, Go WY. Axicabtagene Ciloleucel CAR T-Cell Therapy in Refractory Large B-Cell Lymphoma. N Engl J Med. 2017 Dec 28;377(26):2531-2544. doi: 10.1056/NEJMoa1707447. Epub 2017 Dec 10.

ipd_sharing_description: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and transparency

location_country:
Netherlands
Canada
United States
Israel
France
Germany

location_facility: Washington University School of Medicine

location_facility: University of Iowa Hospitals and Clinics

location_facility: University of California Los Angeles (UCLA)

location_facility: Cleveland Clinic - Taussig Cancer Institute

location_facility: Sarah Cannon-Methodist Healthcare System - San Antonio

location_facility: University of California San Diego (UCSD)

summary:
This study will be separated into 3 distinct phases designated as the Phase 1 study, Phase 2 pivotal study (Cohort 1 and Cohort 2), and Phase 2 safety management study (Cohort 3 and Cohort 4, Cohort 5 and Cohort 6).

The primary objectives of this study are:

Phase 1 Study: Evaluate the safety of axicabtagene ciloleucel regimens
Phase 2 Pivotal Study; Evaluate the efficacy of axicabtagene ciloleucel
Phase 2 Safety Management Study: Assess the impact of prophylactic regimens or earlier interventions on the rate and severity of cytokine release syndrome (CRS) and neurologic toxicities

Subjects who received an infusion of KTE-C19 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968.


title: A Phase 3b, Randomized, Double-Blind Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/ Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Subjects

summary: The primary objective of this study is to evaluate the non-inferiority of switching to emtricitabine/rilpivirine/tenofovir alafenamide (FTC/RPV/TAF) fixed dose combination (FDC) as compared to continuing the non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen of efavirenz /FTC/tenofovir disoproxil fumarate (EFV/FTC/TDF) FDC in virologically-suppressed HIV-1 infected participants.

ReferenceCitation: Hagins D, Orkin C, Daar ES, Mills A, Brinson C, DeJesus E, Post FA, Morales-Ramirez J, Thompson M, Osiyemi O, Rashbaum B, Stellbrink HJ, Martorell C, Liu H, Liu YP, Porter D, Collins SE, SenGupta D, Das M. Switching to coformulated rilpivirine (RPV), emtricitabine (FTC) and tenofovir alafenamide from either RPV, FTC and tenofovir disoproxil fumarate (TDF) or efavirenz, FTC and TDF: 96-week results from two randomized clinical trials. HIV Med. 2018 Nov;19(10):724-733. doi: 10.1111/hiv.12664. Epub 2018 Aug 12.

ReferenceCitation: Mills A, Brinson C, Martorell C, Crofoot G, Daar E, Osiyemi O, et al. Switching to RPV/FTC/TAF from RPV/FTC/TDF or EFV/FTC/TDF: Week 96 Results. Conference on Retroviruses and Opportunistic Infections, Boston. March 4-7, 2018, Abstract 504.

ReferenceCitation: Arribas JR, Rockstroh J, Post, Yazdanpanah Y, Cavassini, DeJesus E, et al. Bone and renal safety of switching to rilpivirine/emtricitabine/tenofovir alafenamide (RPV/FTC/TAF) from single-tablet regimens (STRs) containing efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) or rilpivirine/emtricitabine/tenofovir disoproxil fumarate (RPV/FTC/TDF): Week 48 subgroup analysis in patients at risk of or with comorbidities. Abstract accepted for presentation at the 16th European AIDS Conference, 2017 25-27 October Milan, Italy.

ReferenceCitation: Porter DP, KulkarniR, Cao H, SenGupta D, and White KL. No Emergent Resistance in HIV-1 Virologically-Suppressed Subjects Who Switched to RPV/FTC/TAF [Poster 1381]. ID Week 2017 4-8 October; San Diego, California.

ReferenceCitation: E DeJesus, M Ramgopal, G Crofoot, P Ruane, A LaMarca. J-M Molina et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Older Adults. 8th International Workshop on HIV and Aging 2017 2-3 October, New York, New York.

ReferenceCitation: Molina JM, DeJesus E, Rijnders B, Post FAV, B., Stoeckle M, ThalmeA, et al. Efficacy and Safety of Switching From RPV/FTC/TDF or EFV/FTC/TDF to RPV/FTC/TAF in Black Adults [Presentation MOPEB0291]. 9th IAS Conference on HIV Science 2017 23-26 July Paris, France.

ReferenceCitation: Rockstroh J, Orkin C, Yazdanpanah Y, Di Perri GDS, P. E., Arribas JR, Brinkman K, et al. Switching From TDF to TAF Improves Bone and Renal Safety Independent of Age, Sex, Race, or 3rd Agent: Results From Pooled Analysis (N=3816) of Virologically Suppressed HIV-1 Infected Adults [Presentation MOPEB0289]. 9th IAS Conference on HIV Science; 2017 23 26 July Paris, France.

ReferenceCitation: DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, Mills A, Martorell CT, de Wet J, Stellbrink HJ, Molina JM, Post FA, Valero IP, Porter D, Liu Y, Cheng A, Quirk E, SenGupta D, Cao H. Switching from efavirenz, emtricitabine, and tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study. Lancet HIV. 2017 May;4(5):e205-e213. doi: 10.1016/S2352-3018(17)30032-2. Epub 2017 Mar 2.

ReferenceCitation: Majeed SR, Shao Y, Garner W, Scott J, Pérez-Ruixo C, SenGupta D, et al. Evaluation of RPV/FTC/TAF Exposure-Efficacy and Exposure-Safety Relationships [Poster 427]. Conference on Retroviruses and Opportunistic Infections (CROI) 2017 13-16 February; Seattle, Washington.

ReferenceCitation: Hagins D, Mills A, Martorell C, Walmsley S, Gallant J, Tebas P, et al. Efficacy and Safety of Switching to RPV/FTC/TAF in Women [Abstract 12]. 7th International Workshop on HIV & Women; 2017 11-12 February; Seattle, Washington.

ReferenceCitation: Orkin C, DeJesus E, Ramgopal M, Crofoot G, Ruane P, LaMarca A, et al. 48 Week Results from two studies: Switching to RPV/FTC/TAF from EFV/FTC/TDF (Study 1160) or RPV/FTC/TDF (Study 1216) [Presentation]. HIV Glasgow; 2016 23-26 October; Glasgow, United Kingdom.

lead_sponsor: Gilead Sciences

location_country:
Spain
United Kingdom
Canada
Switzerland
Puerto Rico
United States
France
Belgium
Germany

location_facility: Infectious Disease Specialists of Atlanta

location_facility: University of North Carolina at Chapel Hill

location_facility: Infectious Disease Research Institute Inc.

location_facility: Trinity Health and Wellness Center/AIDS Arms, Inc.

location_facility: Los Angeles BioMedical Institute at Harbor-UCLA Medical Center

location_facility: North Texas Infectious Diseases Consultants

location_facility: Midway Immunology & Research Center, LLC

location_facility: AIDS Arms, Inc./Trinity Health & Wellness Center

location_facility: La Playa Medical Group and Clinical Research

location_facility: Columbia University Medical Center/ New York Presbyterian

location_facility: Center for HIV and Hepatogastroenterology

location_facility: Hospital General Universitario de Alicante

location_facility: Centre Hospitalier Universitaire Vaudois

location_facility: St. Joseph's Comprehensive Research Institute

location_facility: World Health Clinicians' CIRCLE CARE Center

location_facility: AIDS Research & Treatment Center of the Treasure Coast

location_facility: Baystate Infectious Diseases Clinical Research

location_facility: Southwest Infectious Disease Clinical Research, Inc.

location_facility: Clinical Alliance for Research & Education - Infectious Diseases, LLC (CARE-ID)

location_facility: Long Beach Education and Research Consultants

location_facility: Infectious Diseases Associates of NW Florida, P.A.

location_facility: University of Puerto Rico School of Medicine

location_facility: Zentrum für Infektiologie Berlin Prenzlauer Berg GmbH (zibp)


title: A Multicenter, Randomized, Open-Label Study to Assess the Impact of Natalizumab Versus Fingolimod on Central Nervous System Tissue Damage and Recovery in Active Relapsing-Remitting Multiple Sclerosis Subjects

acronym: REVEAL

summary: The primary objective of this study is to assess the effect of natalizumab compared to fingolimod on the evolution of new on-treatment T1-gadolinium-enhancing (Gd+) lesions to persistent black holes (PBH) over 52 weeks. The secondary objectives of this study in this study population are to assess the effect of natalizumab compared to fingolimod on: magnetic resonance imaging (MRI) measures of central nervous system (CNS) tissue destruction as measured by the number of new T1-Gd+ lesions; various other MRI measures of disease activity; No Evidence of Disease Activity (NEDA); Relapse on treatment over 52 weeks; The change in information processing speed as measured by the Symbol Digit Modalities Test (SDMT).

ReferenceCitation: Butzkueven H, Licata S, Jeffery D, Arnold DL, Filippi M, Geurts JJ, Santra S, Campbell N, Ho PR; REVEAL Investigators. Natalizumab versus fingolimod for patients with active relapsing-remitting multiple sclerosis: results from REVEAL, a prospective, randomised head-to-head study. BMJ Open. 2020 Oct 20;10(10):e038861. doi: 10.1136/bmjopen-2020-038861.

lead_sponsor: Biogen

location_country:
Spain
Italy
United Kingdom
Australia
Sweden
United States
France
Germany
Czechia


title: A Multi-national, Multi-center, Prospective, Randomized, Double Blinded, Placebo-controlled Trial to Evaluate the Efficacy of HyperBox Cyclical Topical Wound Oxygen Therapy (TWO2) in the Treatment of Chronic Diabetic Foot Ulcers

summary: The purpose of this study is to evaluate the efficacy, safety and economical benefits of Cyclical Pressure Topical Wound Oxygen (TWO2) Therapy in the treatment of chronic diabetic foot ulcers. Subjects will wear a standardized off-loading device and use advanced moist wound therapy (AMWT) dressings. Following a 2 week run-in period with the standardized care and after meeting all the eligibility criteria, half the subjects will use the TWO2 device, while the other half will use a sham device.

status: Unknown status

ReferenceCitation: Frykberg RG, Franks PJ, Edmonds M, Brantley JN, Téot L, Wild T, Garoufalis MG, Lee AM, Thompson JA, Reach G, Dove CR, Lachgar K, Grotemeyer D, Renton SC; TWO2 Study Group. A Multinational, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy of Cyclical Topical Wound Oxygen (TWO2) Therapy in the Treatment of Chronic Diabetic Foot Ulcers: The TWO2 Study. Diabetes Care. 2020 Mar;43(3):616-624. doi: 10.2337/dc19-0476. Epub 2019 Oct 16.

lead_sponsor: AOTI Ltd.

location_country:
Luxembourg
United Kingdom
United States
France
Germany

location_facility:
NorthBay Center for Wounds
Montpellier University Hospital
Northwick Park Hospital
The Research Center Inc.
Kirchberg Hospital
Advanced Foot & Ankle Center
Hunter Holmes McGuire VA Medical Center
Avicenne Hospital
Carl T. Hayden VA Medical Center
Salem VA Medical Center
Städtisches Klinikum Dessau
Hospital Simone Veil
Advanced Research Institute of Miami
Edward Hines, Jr. VA Hospital
King's College Hospital
Washington DC VA Medical Center

intervention_type: Device


title: Open-Label, Multicenter, Dose Escalation Phase Ib Study With Expansion Phase to Evaluate the Safety, Pharmacokinetics, and Activity of RO5509554 (Emactuzumab) and MPDL3280A (Atezolizumab) Administered in Combination in Patients With Advanced Solid Tumors

summary:
This Phase 1, open-label, multicenter, global study will evaluate the safety, pharmacokinetics, and activity of emactuzumab and atezolizumab administered in combination in participants with selected locally advanced or metastatic solid tumors that are not amenable to standard treatment.

Participants who receive emactuzumab and atezolizumab will continue to receive study drug as long as they experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data, biopsy results (if available), and clinical status, or withdrawal of consent.

ReferenceCitation: Gomez-Roca C, Cassier P, Zamarin D, Machiels JP, Luis Perez Gracia J, Stephen Hodi F, Taus A, Martinez Garcia M, Boni V, Eder JP, Hafez N, Sullivan R, Mcdermott D, Champiat S, Aspeslagh S, Terret C, Jegg AM, Jacob W, Cannarile MA, Ries C, Korski K, Michielin F, Christen R, Babitzki G, Watson C, Meneses-Lorente G, Weisser M, Rüttinger D, Delord JP, Marabelle A. Anti-CSF-1R emactuzumab in combination with anti-PD-L1 atezolizumab in advanced solid tumor patients naïve or experienced for immune checkpoint blockade. J Immunother Cancer. 2022 May;10(5). pii: e004076. doi: 10.1136/jitc-2021-004076.

location_country:
United States
France
Spain
Belgium

location_facility: Centre Leon Berard; Departement Oncologie Medicale

location_facility: Institut Claudius Regaud; Departement Oncologie Medicale

location_facility: Memorial Sloan-Kettering Cancer Center Breast & Imaging Center

location_facility: Institut Gustave Roussy; Departement Oncologie Medicale

location_facility: Clinica Universitaria de Navarra; Servicio de Oncologia

location_facility: Centro Integral Oncológico Clara Campal Ensayos Clínicos START


title: A Randomized, Open-label, 2-arm Parallel-group, Multicenter, 26-week Study Assessing the Safety and Efficacy of H0E901-U300 Versus Lantus in Older Patients With Type 2 Diabetes Inadequately Controlled on Antidiabetic Regimens Either Including no Insulin, or With Basal Insulin as Their Only Insulin

acronym: SENIOR

summary:
Primary Objective:

To demonstrate the non-inferiority of H0E901-U300 to Lantus, in change of glycated hemoglobin A1c (HbA1c).

Secondary Objectives:

To demonstrate the superiority of H0E901-U300 in comparison with Lantus in:

Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL [3.9mmol/L]) hypoglycemia event from 22:00 to 08:59 next morning
Percentage of participants with at least one nocturnal (from 00:00-05:59) severe and/or confirmed (≤70mg/dL [3.9mmol/L]) hypoglycemia event
Percentage of participants with at least one severe and/or confirmed (by plasma glucose ≤70mg/dL [3.9mmol/L]) hypoglycemia event occurring at any time of day
HbA1c change

ReferenceCitation: Ritzel R, Harris SB, Baron H, Florez H, Roussel R, Espinasse M, Muehlen-Bartmer I, Zhang N, Bertolini M, Brulle-Wohlhueter C, Munshi M, Bolli GB. A Randomized Controlled Trial Comparing Efficacy and Safety of Insulin Glargine 300 Units/mL Versus 100 Units/mL in Older People With Type 2 Diabetes: Results From the SENIOR Study. Diabetes Care. 2018 Aug;41(8):1672-1680. doi: 10.2337/dc18-0168. Epub 2018 Jun 12. Erratum in: Diabetes Care. 2019 Aug;42(8):1604.

lead_sponsor: Sanofi

location_country:
Poland
Romania
Spain
Italy
United Kingdom
Australia
Mexico
Argentina
Canada
Sweden
Hungary
Korea, Republic of
United States
France
Peru
Colombia
Japan
Germany

location_facility:
Investigational Site Number 840027
Investigational Site Number 826003
Investigational Site Number 840006
Investigational Site Number 032001
Investigational Site Number 170003
Investigational Site Number 840058
Investigational Site Number 840022
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Investigational Site Number 392003
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Investigational Site Number 392008
Investigational Site Number 032003
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Investigational Site Number 170007
Investigational Site Number 840055
Investigational Site Number 642003
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Investigational Site Number 616005
Investigational Site Number 170005
Investigational Site Number 604002
Investigational Site Number 724005
Investigational Site Number 170004
Investigational Site Number 392004
Investigational Site Number 840024
Investigational Site Number 724003
Investigational Site Number 826001
Investigational Site Number 840018
Investigational Site Number 840045
Investigational Site Number 124001
Investigational Site Number 724004
Investigational Site Number 642001
Investigational Site Number 250004
Investigational Site Number 724008
Investigational Site Number 604007
Investigational Site Number 250005
Investigational Site Number 124006
Investigational Site Number 604003
Investigational Site Number 604001
Investigational Site Number 840059
Investigational Site Number 840070
Investigational Site Number 616002
Investigational Site Number 484003
Investigational Site Number 840061
Investigational Site Number 410005
Investigational Site Number 348009
Investigational Site Number 032004
Investigational Site Number 840004
Investigational Site Number 826002
Investigational Site Number 348003
Investigational Site Number 642004
Investigational Site Number 840025
Investigational Site Number 276005
Investigational Site Number 840064
Investigational Site Number 840033
Investigational Site Number 840032
Investigational Site Number 276003
Investigational Site Number 484001
Investigational Site Number 348008
Investigational Site Number 826004
Investigational Site Number 392012
Investigational Site Number 752002
Investigational Site Number 840046
Investigational Site Number 840026
Investigational Site Number 124002
Investigational Site Number 840002
Investigational Site Number 840003
Investigational Site Number 276001
Investigational Site Number 840014
Investigational Site Number 124005
Investigational Site Number 840037
Investigational Site Number 840041
Investigational Site Number 032006
Investigational Site Number 840047
Investigational Site Number 604006
Investigational Site Number 840001
Investigational Site Number 840048
Investigational Site Number 826006
Investigational Site Number 840029
Investigational Site Number 840020
Investigational Site Number 032002
Investigational Site Number 124009
Investigational Site Number 616001
Investigational Site Number 840031
Investigational Site Number 410001
Investigational Site Number 484004
Investigational Site Number 276004
Investigational Site Number 348005
Investigational Site Number 642007
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Investigational Site Number 124010
Investigational Site Number 380005
Investigational Site Number 036002


primary_purpose: Prevention

title: OPuS-2: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX4161 for 12 Weeks as an Oral Prophylaxis Treatment for Attacks of Hereditary Angioedema

lead_sponsor: BioCryst Pharmaceuticals

ReferenceCitation: Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11:CD013403. doi: 10.1002/14651858.CD013403.pub2. Review.

location_country:
United Kingdom
Italy
Canada
Hungary
United States
France
Belgium
Germany

summary: This study will evaluate the safety and efficacy of an oral treatment, BCX4161, in preventing acute attacks in subjects with hereditary angioedema (HAE). Eligible subjects will be randomized to receive one of two doses of BCX4161 or placebo for 12 weeks. The study will compare the number of acute attacks in each treatment group, as well as a number of other clinical outcomes, and the safety and tolerability of each dose of BCX4161 compared to placebo.


title: β-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab An Open-label Canakinumab (ACZ885) Dose Reduction or Dose Interval Prolongation Efficacy and Safety Study in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)

acronym: ß-SPECIFIC 4

summary: The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.

ReferenceCitation: Quartier P, Alexeeva E, Constantin T, Chasnyk V, Wulffraat N, Palmblad K, Wouters C, I Brunner H, Marzan K, Schneider R, Horneff G, Martini A, Anton J, Wei X, Slade A, Ruperto N, Abrams K; Paediatric Rheumatology International Trials Organisation and the Pediatric Rheumatology Collaborative Study Group. Tapering Canakinumab Monotherapy in Patients With Systemic Juvenile Idiopathic Arthritis in Clinical Remission: Results From a Phase IIIb/IV Open-Label, Randomized Study. Arthritis Rheumatol. 2021 Feb;73(2):336-346. doi: 10.1002/art.41488. Epub 2020 Dec 11.

ipd_sharing: Undecided

location_country:
Poland
Brazil
Spain
Italy
Austria
Netherlands
Russian Federation
Canada
Sweden
Hungary
United States
France
Israel
Turkey
Belgium
Germany


title: A Multicenter, Multinational, Observational Morquio A Registry Study (MARS)

acronym: MARS

summary: The objectives of this program are: to characterize and describe the Mucopolysaccharidosis IV type A (MPS IVA) population as a whole, including the heterogeneity, progression, and natural history of MPS IVA; to evaluate the long-term effectiveness and safety of Vimizim®, including, but not limited to, the occurrence of serious hypersensitivity reactions, anaphylaxis, and changes in antibody status; to help the medical community with the development of recommendations for monitoring MPS IVA patients and reports on patient outcomes to optimize patient care; to collect data on other treatment paradigms, and evaluate the prevalences of their use and their effectiveness; to characterize the effects and safety of Vimizim treatment 5 years from enrollment in the Registry for patients under 5 years of age; to monitor pregnancy exposure, including maternal, neonatal, and infant outcomes; and to monitor patients who have completed the MOR-005 and MOR-007 clinical trials. These patients will be encouraged to enroll in the applicable Registry Substudy and will be monitored using the MOR-005 and MOR-007 assessment schedules, respectively.

study_type: Observational

time_perspective: Prospective

ipd_sharing: No

lead_sponsor: BioMarin Pharmaceutical

location_country:
Denmark
Poland
Taiwan
Portugal
United Kingdom
Ireland
Austria
Australia
Italy
Canada
Netherlands
Puerto Rico
United States
France
Belgium
Malaysia
Czechia

location_facility: Adult Metabolic Diseases Clinic Vancouver General Hospital

location_facility: Chang Gung Memorial Hospital Kaohsiung Branch

location_facility: Azienda Policlinico Vittorio Emanuele, presidio G Rodolico, Università di Catania

location_facility: Temple Street Children's University Hospital

location_facility: National Cheng Kung University (NCKU) Hospital

location_facility: San Jorge Children's Hospital, Centro de Investigaciones Clinicas

location_facility: Klinika Dětského a Dorostového Lékařstvi

location_facility: Children's Hospital of Pittsburgh of UPMC

location_facility: University Hospital Birmingham - Selly Oaks

location_facility: Kapiolani Medical Center for Women and Children

location_facility: NYU-Langone Medical Center School of Medicine

location_facility: Hospital Pediátrico de Coimbra (Centro Hospitalar de Coimbra)

location_facility: Children's & Women's Centre of British Columbia

location_facility: Children's Hospitals and Clinics of Minnesota

location_facility: Copenhagen University Hospital, Klinik For Sjaeldne Handicap

location_facility: Children's Hospital of the King's Daughters

location_facility: Azienda Ospedaliero San Gerardo di Monza

location_facility: University of Louisville Research Foundation Inc. - Kosair Charities Pediatric Clinical Research Unit

location_facility: National Hospital for Neurology and Neurosurgery

location_facility: Academic Medical Center - University of Amsterdam

location_facility: Centro Hospitalar Lisboa Centro - Hospital de Dona Estefânia

location_facility: Rotterdam University Hospital Medical Centre

location_facility: Children's Health Queensland Hospital and Health Service

location_facility: Great Ormond Street Hospital NHS Foundation Trust

location_facility: Kaohsiung Medical University Chung-Ho Memorial Hospital

location_facility: Royal Manchester Children's Hospital - Manchester University NHS Foundation Trust

location_facility: Ann & Robert H. Lurie Children's Hospital


title: A Phase 1 Dose Escalation and Phase 2 Randomized Double-Blind Study of Veliparib in Combination With Carboplatin and Etoposide as a Therapy of Treatment-Naïve Extensive Stage Disease Small Cell Lung Cancer

lead_sponsor: AbbVie

ReferenceCitation: Atrafi F, Groen HJM, Byers LA, Garralda E, Lolkema MP, Sangha RS, Viteri S, Chae YK, Camidge DR, Gabrail NY, Hu B, Tian T, Nuthalapati S, Hoening E, He L, Komarnitsky P, Calles A. A Phase I Dose-Escalation Study of Veliparib Combined with Carboplatin and Etoposide in Patients with Extensive-Stage Small Cell Lung Cancer and Other Solid Tumors. Clin Cancer Res. 2019 Jan 15;25(2):496-505. doi: 10.1158/1078-0432.CCR-18-2014. Epub 2018 Oct 16.

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

location_country:
Romania
Spain
Russian Federation
Australia
Canada
Hungary
Korea, Republic of
United States
France
Belgium
Netherlands
Czechia

location_facility: Oncocenter Oncologie Clinica S /ID# 151694

location_facility: Univercity Headache Clynic,LTD /ID# 161708

location_facility: Herbert Herman Cancer Center /ID# 167020

location_facility: Cliniques Universitaires Saint Luc /ID# 151024

location_facility: Chonnam National University Hwasun Hospital /ID# 153188

location_facility: Centre Hosp Intercommunal de Creteil /ID# 157970

location_facility: Hosp Univ Puerta de Hierro Maj /ID# 151253

location_facility: Univ of Colorado Cancer Center /ID# 129220

location_facility: Gabrail Cancer Center Research /ID# 129216

location_facility: Northwestern University Feinberg School of Medicine /ID# 137088

location_facility: Veszprem Megyei Tudogyogyintez /ID# 158807

location_facility: Hospital Stanta Creu i Sant Pau /ID# 151254

location_facility: Hosp Univ Madrid Sanchinarro /ID# 130301

location_facility: Atrium-Orbis Zuyderland Medisch Centrum /ID# 149830

location_facility: Markusovszky Egyetemi Oktatókórház /ID# 158806

location_facility: Petz Aladar Megyei Oktato Korh /ID# 155352

location_facility: University of Texas MD Anderson Cancer Center /ID# 129213

location_facility: Fejer Megyei Szent Gyorgy Korh /ID# 151352

location_facility: Hopital du Sacre Coeur Montreal /ID# 154436

location_facility: Orszagos Koranyi Pulmonologiai Intezet /ID# 151351

location_facility: S.C. Centrul de Oncologie Sf. Nectarie S.R.L. /ID# 161137

location_facility: S.C. Radiotherapy Center Cluj /ID# 165137

location_facility: Sverdlovsk Regional Oncology Center Dispensary /ID# 152328

location_facility: Universitair Medisch Centrum Groningen /ID# 131252

location_facility: Belgorod Oncology Dispensary /ID# 152330

location_facility: Road Hospital Open Joint Stock Company Russian Railways /ID# 152731

location_facility: Debreceni Egyetem Klinikai Központ /ID# 151354

location_facility: Peninsula & South Eastern Haem /ID# 155497

location_facility: Southern Medical Day Care Ctr /ID# 155498

location_facility: Hospital Universitario Gregori /ID# 164982

summary: The study seeks to assess the efficacy of veliparib (ABT-888) in combination with carboplatin and etoposide in participants with extensive disease small cell lung cancer (ED SCLC).


acronym: SOLO 2

title: A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab Monotherapy Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

lead_sponsor: Regeneron Pharmaceuticals

ReferenceCitation: Simpson EL, Bieber T, Guttman-Yassky E, Beck LA, Blauvelt A, Cork MJ, Silverberg JI, Deleuran M, Kataoka Y, Lacour JP, Kingo K, Worm M, Poulin Y, Wollenberg A, Soo Y, Graham NM, Pirozzi G, Akinlade B, Staudinger H, Mastey V, Eckert L, Gadkari A, Stahl N, Yancopoulos GD, Ardeleanu M; SOLO 1 and SOLO 2 Investigators. Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis. N Engl J Med. 2016 Dec 15;375(24):2335-2348. Epub 2016 Sep 30.

ReferenceCitation: Silverberg JI, Boguniewicz M, Hanifin J, Papp KA, Zhang H, Rossi AB, Levit NA. Dupilumab Treatment in Adults with Moderate-to-Severe Atopic Dermatitis is Efficacious Regardless of Age of Disease Onset: a Post Hoc Analysis of Two Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2022 Oct 21. doi: 10.1007/s13555-022-00822-x. [Epub ahead of print]

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

ReferenceCitation: Armstrong A, Blauvelt A, Simpson EL, Smith CH, Herranz P, Kataoka Y, Seo SJ, Ferrucci SM, Chao J, Chen Z, Rossi AB, Shumel B, Tomondy P. Continued Treatment with Dupilumab is Associated with Improved Efficacy in Adults with Moderate-to-Severe Atopic Dermatitis Not Achieving Optimal Responses with Short-Term Treatment. Dermatol Ther (Heidelb). 2022 Jan;12(1):195-202. doi: 10.1007/s13555-021-00643-4. Epub 2021 Dec 13.

ReferenceCitation: Paller AS, Tan JKL, Bagel J, Rossi AB, Shumel B, Zhang H, Abramova A. IGAxBSA composite for assessing disease severity and response in patients with atopic dermatitis. Br J Dermatol. 2022 Mar;186(3):496-507. doi: 10.1111/bjd.20872. Epub 2022 Feb 25.

ReferenceCitation: Griffiths C, de Bruin-Weller M, Deleuran M, Fargnoli MC, Staumont-Sallé D, Hong CH, Sánchez-Carazo J, Foley P, Seo SJ, Msihid J, Chen Z, Cyr SL, Rossi AB. Dupilumab in Adults with Moderate-to-Severe Atopic Dermatitis and Prior Use of Systemic Non-Steroidal Immunosuppressants: Analysis of Four Phase 3 Trials. Dermatol Ther (Heidelb). 2021 Aug;11(4):1357-1372. doi: 10.1007/s13555-021-00558-0. Epub 2021 Jun 18.

ReferenceCitation: Hamilton JD, Harel S, Swanson BN, Brian W, Chen Z, Rice MS, Amin N, Ardeleanu M, Radin A, Shumel B, Ruddy M, Patel N, Pirozzi G, Mannent L, Graham NMH. Dupilumab suppresses type 2 inflammatory biomarkers across multiple atopic, allergic diseases. Clin Exp Allergy. 2021 Jul;51(7):915-931. doi: 10.1111/cea.13954. Epub 2021 Jun 26.

ReferenceCitation: Boguniewicz M, Beck LA, Sher L, Guttman-Yassky E, Thaci D, Blauvelt A, Worm M, Corren J, Soong W, Lio P, Rossi AB, Lu Y, Chao J, Eckert L, Gadkari A, Hultsch T, Ruddy M, Mannent LP, Graham NMH, Pirozzi G, Chen Z, Ardeleanu M. Dupilumab Improves Asthma and Sinonasal Outcomes in Adults with Moderate to Severe Atopic Dermatitis. J Allergy Clin Immunol Pract. 2021 Mar;9(3):1212-1223.e6. doi: 10.1016/j.jaip.2020.12.059. Epub 2021 Jan 13.

ReferenceCitation: Silverberg JI, Simpson EL, Guttman-Yassky E, Cork MJ, de Bruin-Weller M, Yosipovitch G, Eckert L, Chen Z, Ardeleanu M, Shumel B, Hultsch T, Rossi AB, Hamilton JD, Orengo JM, Ruddy M, Graham NMH, Pirozzi G, Gadkari A. Dupilumab Significantly Modulates Pain and Discomfort in Patients With Atopic Dermatitis: A Post Hoc Analysis of 5 Randomized Clinical Trials. Dermatitis. 2021 Oct 1;32(1S):S81-S91. doi: 10.1097/DER.0000000000000698.

ReferenceCitation: Alexis AF, Rendon M, Silverberg JI, Pariser DM, Lockshin B, Griffiths CE, Weisman J, Wollenberg A, Chen Z, Davis JD, Li M, Eckert L, Gadkari A, Shumel B, Rossi AB, Graham NM, Ardeleanu M. Efficacy of Dupilumab in Different Racial Subgroups of Adults With Moderate-to-Severe Atopic Dermatitis in Three Randomized, Placebo-Controlled Phase 3 Trials. J Drugs Dermatol. 2019 Aug 1;18(8):804-813.

ReferenceCitation: Wollenberg A, Beck LA, Blauvelt A, Simpson EL, Chen Z, Chen Q, Shumel B, Khokhar FA, Hultsch T, Rizova E, Rossi AB, Graham NMH, Pirozzi G, Lu Y, Ardeleanu M. Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY AD CHRONOS). Br J Dermatol. 2020 May;182(5):1120-1135. doi: 10.1111/bjd.18434. Epub 2019 Dec 1.

ReferenceCitation: Silverberg JI, Simpson EL, Ardeleanu M, Thaçi D, Barbarot S, Bagel J, Chen Z, Eckert L, Chao J, Korotzer A, Rizova E, Rossi AB, Lu Y, Graham NMH, Hultsch T, Pirozzi G, Akinlade B. Dupilumab provides important clinical benefits to patients with atopic dermatitis who do not achieve clear or almost clear skin according to the Investigator's Global Assessment: a pooled analysis of data from two phase III trials. Br J Dermatol. 2019 Jul;181(1):80-87. doi: 10.1111/bjd.17791. Epub 2019 Apr 11.

ReferenceCitation: Simpson EL. Dupilumab Improves General Health-Related Quality-of-Life in Patients with Moderate-to-Severe Atopic Dermatitis: Pooled Results from Two Randomized, Controlled Phase 3 Clinical Trials. Dermatol Ther (Heidelb). 2017 Jun;7(2):243-248. doi: 10.1007/s13555-017-0181-6. Epub 2017 May 13.

location_country:
Poland
Hong Kong
United Kingdom
Italy
Canada
Lithuania
Sweden
Korea, Republic of
United States
France
Germany

summary: This is a randomized, double-blind, placebo-controlled, parallel-group study to confirm the efficacy and safety of Dupilumab monotherapy in adults with moderate-to-severe atopic dermatitis (AD).


title: A Phase 2, Multicenter, International, Single Arm Study To Assess The Safety And Efficacy Of Single Agent Cc-486 (Oral Azacitidine) In Previously Treated Subjects With Locally Advanced Or Metastatic Nasopharyngeal Carcinoma

summary: The purpose of this study is to evaluate the safety and efficacy of CC-486 in previously treated patients with locally advanced or metastatic nasopharyngeal carcinoma having failed one to two previous regimens, including platinum-based chemotherapy. Participants will be enrolled according to a Simon two-stage design; if the predefined activity is met (>4 responses [complete response; partial response {CR/PR}] out of the first 17 evaluable participants based on independent radiological assessment), then the study will continue to enroll an additional 34 participants. If 4 or less responses out of 17 are observed, then the study enrollment will be stopped.

ReferenceCitation: Von Hoff DD, Rasco DW, Heath EI, Munster PN, Schellens JHM, Isambert N, Le Tourneau C, O'Neil B, Mathijssen RHJ, Lopez-Martin JA, Edenfield WJ, Martin M, LoRusso PM, Bray GL, DiMartino J, Nguyen A, Liu K, Laille E, Bendell JC. Phase I Study of CC-486 Alone and in Combination with Carboplatin or nab-Paclitaxel in Patients with Relapsed or Refractory Solid Tumors. Clin Cancer Res. 2018 Sep 1;24(17):4072-4080. doi: 10.1158/1078-0432.CCR-17-3716. Epub 2018 May 15.

location_country:
Taiwan
Spain
Italy
Greece
Canada
Tunisia
United States
France
Singapore

location_facility: Johns Hopkins Singapore International Medical Centre

location_facility: Chang Gung Medical Foundation, Kaohsiung Memorial Hospital

location_facility: Hospital Universitario Madrid Sanchinarro

location_facility: Hopital Abderrahman Mami de Pneumo-Phtisiologie de l'Ariana

location_facility: Instituto Catalan de Oncologia-Hospital Duran

location_facility: Columbia Comprehensive Cancer Care Clinic

location_facility: University General Hospital of Heraklion

location_facility: Winship Cancer Institute of Emory University


title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Multi-Center Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of GS-5806 in Hematopoietic Cell Transplant (HCT) Recipients With Respiratory Syncytial Virus (RSV) Infection of the Lower Respiratory Tract

summary: The primary objective of this study is to evaluate the effect of presatovir on respiratory syncytial virus (RSV) viral load in autologous or allogeneic hematopoietic cell transplant (HCT) recipients with an acute RSV lower respiratory tract infection (LRTI).

ReferenceCitation: Marty FM, Chemaly RF, Mullane KM, Lee DG, Hirsch HH, Small CB, Bergeron A, Shoham S, Ljungman P, Waghmare A, Blanchard E, Kim YJ, McKevitt M, Porter DP, Jordan R, Guo Y, German P, Boeckh M, Watkins TR, Chien JW, Dadwal SS. A Phase 2b, Randomized, Double-blind, Placebo-Controlled Multicenter Study Evaluating Antiviral Effects, Pharmacokinetics, Safety, and Tolerability of Presatovir in Hematopoietic Cell Transplant Recipients with Respiratory Syncytial Virus Infection of the Lower Respiratory Tract. Clin Infect Dis. 2020 Dec 31;71(11):2787-2795. doi: 10.1093/cid/ciz1167.

location_country:
Switzerland
Korea, Republic of
United States
France
Sweden

location_facility:
Dana Farber Cancer Institute
New York Weill Cornell Medical Center
University of Chicago
Fred Hutchison Cancer Research Center
University of Minnesota
City of Hope
Medical College of Wisconsin
Hopital Saint-Louis, APHP
Seoul Saint Mary's Hospital
University Clinical Basel
Hopital Foch
CHU de Bordeaux
Duke University
University of Michigan
John Hopkins
MD Anderson Cancer Center
Karolinska Institutet


title: DISCOVERY: A Study Examining the Prevalence of TTR Mutations in Subjects Suspected of Having Cardiac Amyloidosis

summary: The purpose of this study is to characterize the frequency of TTR mutations in subjects suspected of having cardiac amyloidosis

lead_sponsor: Alnylam Pharmaceuticals

location_country:
Brazil
Spain
United Kingdom
France
United States
Belgium


title: A Phase 2, Open-Label, Multi-Center Study to Assess Safety and Efficacy of Second/Third-Line Treatment With NAB®-Paclitaxel (ABI-007) In Combination With Epigenetic Modifying Therapy Of CC-486, Or Immunotherapy of Durvalumab (MEDI4736), Or As Monotherapy In Subjects With Advanced Non-Small Cell Lung Cancer (NSCLC): Abound.2L+

ReferenceType: background

ReferenceCitation: Yardley DA, Coleman R, Conte P, Cortes J, Brufsky A, Shtivelband M, Young R, Bengala C, Ali H, Eakel J, Schneeweiss A, de la Cruz-Merino L, Wilks S, O'Shaughnessy J, Glück S, Li H, Miller J, Barton D, Harbeck N; tnAcity investigators. nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial. Ann Oncol. 2018 Aug 1;29(8):1763-1770. doi: 10.1093/annonc/mdy201.

ReferenceCitation: Metts JL, Alazraki AL, Clark D, Amankwah EK, Wasilewski-Masker KJ, George BA, Olson TA, Cash T. Gemcitabine/nab-paclitaxel for pediatric relapsed/refractory sarcomas. Pediatr Blood Cancer. 2018 Sep;65(9):e27246. doi: 10.1002/pbc.27246. Epub 2018 May 17.

ReferenceCitation: Kim S, Signorovitch JE, Yang H, Patterson-Lomba O, Xiang CQ, Ung B, Parisi M, Marshall JL. Comparative Effectiveness of nab-Paclitaxel Plus Gemcitabine vs FOLFIRINOX in Metastatic Pancreatic Cancer: A Retrospective Nationwide Chart Review in the United States. Adv Ther. 2018 Oct;35(10):1564-1577. doi: 10.1007/s12325-018-0784-z. Epub 2018 Sep 12.

ReferenceCitation: Weiss J, Gilbert J, Deal AM, Weissler M, Hilliard C, Chera B, Murphy B, Hackman T, Liao JJ, Grilley Olson J, Hayes DN. Induction chemotherapy with carboplatin, nab-paclitaxel and cetuximab for at least N2b nodal status or surgically unresectable squamous cell carcinoma of the head and neck. Oral Oncol. 2018 Sep;84:46-51. doi: 10.1016/j.oraloncology.2018.06.028. Epub 2018 Jul 19.

ReferenceCitation: Cartwright TH, Parisi M, Espirito JL, Wilson TW, Pelletier C, Patel M, Babiker HM. Clinical Outcomes with First-Line Chemotherapy in a Large Retrospective Study of Patients with Metastatic Pancreatic Cancer Treated in a US Community Oncology Setting. Drugs Real World Outcomes. 2018 Sep;5(3):149-159. doi: 10.1007/s40801-018-0137-x.

ReferenceCitation: Li F, Zhang H, He M, Liao J, Chen N, Li Y, Zhou S, Palmisano M, Yu A, Pai MP, Yuan H, Sun D. Different Nanoformulations Alter the Tissue Distribution of Paclitaxel, Which Aligns with Reported Distinct Efficacy and Safety Profiles. Mol Pharm. 2018 Oct 1;15(10):4505-4516. doi: 10.1021/acs.molpharmaceut.8b00527. Epub 2018 Sep 21.

ReferenceCitation: Langer CJ, Kim ES, Anderson EC, Jotte RM, Modiano M, Haggstrom DE, Socoteanu MP, Smith DA, Dakhil C, Konduri K, Berry T, Ong TJ, Sanford A, Amiri K, Goldman JW, Weiss J; ABOUND.70+ Investigators. nab-Paclitaxel-Based Therapy in Underserved Patient Populations: The ABOUND.70+ Study in Elderly Patients With Advanced NSCLC. Front Oncol. 2018 Jul 24;8:262. doi: 10.3389/fonc.2018.00262. eCollection 2018.

ReferenceCitation: Gajra A, Karim NA, Mulford DA, Villaruz LC, Matrana MR, Ali HY, Santos ES, Berry T, Ong TJ, Sanford A, Amiri K, Spigel DR. nab-Paclitaxel-Based Therapy in Underserved Patient Populations: The ABOUND.PS2 Study in Patients With NSCLC and a Performance Status of 2. Front Oncol. 2018 Jul 24;8:253. doi: 10.3389/fonc.2018.00253. eCollection 2018.

ReferenceCitation: Pelzer U, Wislocka L, Jühling A, Striefler J, Klein F, Roemmler-Zehrer J, Sinn M, Denecke T, Bahra M, Riess H. Safety and efficacy of Nab-paclitaxel plus gemcitabine in patients with advanced pancreatic cancer suffering from cholestatic hyperbilirubinaemia-A retrospective analysis. Eur J Cancer. 2018 Sep;100:85-93. doi: 10.1016/j.ejca.2018.06.001. Epub 2018 Jul 4.

ReferenceCitation: Moreno L, Casanova M, Chisholm JC, Berlanga P, Chastagner PB, Baruchel S, Amoroso L, Gallego Melcón S, Gerber NU, Bisogno G, Fagioli F, Geoerger B, Glade Bender JL, Aerts I, Bergeron C, Hingorani P, Elias I, Simcock M, Ferrara S, Le Bruchec Y, Slepetis R, Chen N, Vassal G. Phase I results of a phase I/II study of weekly nab-paclitaxel in paediatric patients with recurrent/refractory solid tumours: A collaboration with innovative therapies for children with cancer. Eur J Cancer. 2018 Sep;100:27-34. doi: 10.1016/j.ejca.2018.05.002. Epub 2018 Jun 21.

ReferenceCitation: Topçul M, Çeti N İL, Özbaş Turan S, Kolusayin Ozar MÖ. In vitro cytotoxic effect of PARP inhibitor alone and in combination with nab-paclitaxel on triple-negative and luminal A breast cancer cells. Oncol Rep. 2018 Jul;40(1):527-535. doi: 10.3892/or.2018.6364. Epub 2018 Apr 12.

ReferenceCitation: Young R, Mainwaring P, Clingan P, Parnis FX, Asghari G, Beale P, Aly A, Botteman M, Romano A, Ferrara S, Margunato-Debay S, Harris M. nab-Paclitaxel plus gemcitabine in metastatic pancreatic adenocarcinoma: Australian subset analyses of the phase III MPACT trial. Asia Pac J Clin Oncol. 2018 Oct;14(5):e325-e331. doi: 10.1111/ajco.12999. Epub 2018 Jun 22.

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location_country:
Spain
Italy
United Kingdom
Canada
United States
France
Germany

location_facility: Royal Victoria Hospital McGill Department of Oncology(RVH)

location_facility: Hospital General Universitario de Valencia

location_facility: Hospital Universitari i Politecnic La Fe de Valencia

location_facility: Azienda Ospedaliero Universitaria di Parma

location_facility: Weill Cornell Medical College - New York - Presbyterian Hospital

location_facility: University Hospital of South Manchester NHS Foundation Trust -Wythenshawe Hospital - North West Lung

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

location_facility: Penn State Milton S Hershey Medical Center

location_facility: Azienda Ospedaliero-Universitaria Santa Maria della Misericordia die Udine

location_facility: John Theurer Cancer Center at Hackensack University Medical Center

location_facility: Hospital of Central Connecticut Gynecologic Oncology

location_facility: Hospital Universitario Germans Trias i Pujol

location_facility: Centre Rene Gauducheau Centre de Lutte Contre Le Cancer Nantes Atlantique

summary: This is a Phase 2, open-label, multicenter study to assess the efficacy and safety of second/third-line treatment with nab-paclitaxel in combination with the epigenetic modifying therapy of CC-486 or immunotherapy of durvalumab, and nab-paclitaxel monotherapy in subjects with advanced non-small cell lung cancer (NSCLC).


title: An Open-Label, Extension Study of the Effects of LMTM in Subjects With Alzheimer's Disease or Behavioral Variant Frontotemporal Dementia (bvFTD)

summary: The purpose of this study is to provide subjects who have completed participation in a Phase 2 or Phase 3 trial of LMTM continued access to therapy and to evaluate the long-term safety of LMTM.

lead_sponsor: TauRx Therapeutics Ltd

location_country:
Croatia
Taiwan
Romania
Spain
United Kingdom
Russian Federation
Australia
Netherlands
Canada
Finland
Korea, Republic of
United States
France
Malaysia
Singapore
Belgium
Germany

location_facility: Medical and Cognitive Research Unit, Austin Health Heidelberg Repatriation Hospital

location_facility: Neurological Associates of Albany, P. C.

location_facility: University Kuala Lumpur Royal College of Medicine

location_facility: Division of Rehabilitation and Aged Care

location_facility: Kingshill Research Centre, Victoria Hospital

location_facility: Mayo Clinic, Alzheimer's Disease Research Center

location_facility: Sussex Partnership NHS Foundation Trust, Cognitive Treatment and Research Unit

location_facility: Leonard Wolfson Experimental Neurology Centre

location_facility: University of Virginia Adult Neurology, Primary Care Center

location_facility: Nuffield Department of Clinical Neurosciences

location_facility: Belfast Health and Social Care Trust (BHSCT)

location_facility: Charité, University Medicine Berlin, CBF, Neurology

location_facility: Saint Petersburg Psychoneurological Research Institute n. a. V.M. Bekhterev

location_facility: University Hospitals Case Medical Center, Neurology Clinical Trials Unit

location_facility: Seoul National University Boramae Medical Center

location_facility: Ruan Neurology Clinic and Research Center

location_facility: Memory Enhancement Center of America, Inc

location_facility: Neurodegenerative Disorders Research Pty Ltd

location_facility: Psychiatry Hospital "Dr. Gheorghe Preda", Department of Psychiatry III

location_facility: University Hospital Centre Zagreb, Department of Neurology

location_facility: University of Eastern Finland, Brain Research Unit Mediteknia

location_facility: Hospital of the University of Pennsylvania, Department of Neurology

location_facility: St Margaret's Hospital Mental Health Unit

location_facility: Research Foundation for Mental Hygiene, Inc.

location_facility: Institute for Neurodegenerative Disorders

location_facility: Geriatric Clinical Trials Group, St. Joseph's Health Care, Parkwood Hospital Site

location_facility: Non-governmental Healthcare Institution "Central Clinical Hospital #6 of the JSC "Russian Railways"

location_facility: Advanced Memory Research Institute of NJ PC

location_facility: McCusker Alzheimer's Research Foundation Inc

location_facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital

location_facility: True North Clinical Research Halifax Inc

location_facility: McGill Centre for Studies in Aging, Alzheimer Disease Research Unit

location_facility: University Hospital Ghent Department of Neurology

location_facility: UNC Department of Neurology, Physicians Office Building

location_facility: City Clinical Hospital #34, City Scientific Practical Neurological Center

location_facility: Royal Adelaide Hospital Memory Trials Centre

location_facility: Memory Assessment and Research Centre (MARC)

location_facility: Wessex Neurological Centre, Southampton General Hospital

location_facility: Mental Health Research Center of the Russian Academy of Medical Sciences, Gerontopsychiatry department

location_facility: Xenoscience, Inc / 21st Century Neurology

location_facility: True North Clinical Research Kentville Inc

location_facility: Discipline of Psychiatry, University of Queensland

location_facility: Neurological Research Center - Hattiesburg Clinic

location_facility: RICE - The Research Institute for the Care of Older People

location_facility: State Budgetary Healthcare Institution of Sverdlovsk region "Sverdlovsk Regional Clinical Psychiatric Hospital"

location_facility: University of British Columbia Hospital, Clinic for Alzheimer Disease and Related Disorders

location_facility: City Geriatric Medical and Social Center

location_facility: Alexian Brothers Neurosciences Institute

location_facility: Clinical Neuroscience Solutions CNS Healthcare


title: A Phase 2A Study of ALXN1007 in Subjects With Newly Diagnosed Acute Graft-Versus-Host Disease Involving the Lower Gastrointestinal Tract

acronym: GIGVHD

summary: The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower gastrointestinal (GI) tract.

lead_sponsor: Alexion Pharmaceuticals

location_country:
United States
France

location_facility: Abramson Cancer Perelman Center for Advanced Medicine, University of Pennsylvania

location_facility: University of Minnesota Medicine - Hematology, Oncology and Transplantation Office

location_facility: Groupe Hospitalier Sud - Hôpital Haut-Lévêque - Centre François

location_facility: The University of Texas MD Anderson Cancer Center