title: Evaluating the Long-Term Outcomes and Durability of Effect Following Treatment With Cladribine Tablets for MS: An Exploratory Phase IV Ambispective Study of Patients Who Previously Participated in the CLARITY/CLARITY-EXT and ORACLE MS Clinical Trials (CLASSIC-MS)

summary: The objective of this study was to collect data both retrospectively and prospectively in order to evaluate the long-term outcomes, durability of effect, and real-world treatment patterns following treatment with Cladribine Tablets or placebo in participants with multiple sclerosis (MS) who were previously participated in the parent studies (ORACLE MS and CLARITY/CLARITY-EXT).

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, EMD Serono 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.emdgroup.com/en/research/our-approach-to-research-and-development/healthcare/clinical-trials/commitment-responsible-data-sharing.html

lead_sponsor: EMD Serono Research & Development Institute, Inc.

location_country:
Croatia
Serbia
Spain
Italy
United Kingdom
Lithuania
Ukraine
United States
Romania
Belgium
Czechia
Poland
Portugal
Austria
Australia
Russian Federation
Tunisia
Norway
Sweden
Lebanon
Canada
Switzerland
Germany
Bulgaria
Georgia
Estonia
Finland
Korea, Republic of
France

location_facility: Regional Multiple Sclerosis Centre b/o CC ECM "Neftyanik" - Neurology

location_facility: Clinical Center Nis - Clinic of Neurology

location_facility: Heinrich-Heine-Universitaet Duesseldorf - Klinik fuer Nephrologie

location_facility: Fakultni nemocnice Olomouc - Neurologicka klinika

location_facility: Szpital im. Mikołaja Kopernika - Neurology

location_facility: Azienda Ospedaliera Universitaria Policlinico Tor Vergata - Dip. Neuroscienze-Centro per la Sclerosi Multipla

location_facility: Royal Hallamshire Hospital - Dept of Neurology

location_facility: SI Institute of Neurology, Psychiatry and Narcology of NAMSU - Dept of Neuroinfections and Multiple Sclerosis

location_facility: MHAT - "National Heart Hospital" EAD - Multiple Clinics

location_facility: NHI "Central Clinical Hospital #2 of JSC "Russian Railways" n.a. N.A. Semashko

location_facility: Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Dept of Neurology

location_facility: Vinnitsa State Medical University - Neurology dept

location_facility: Hospital Universitario Nuestra Señora de la Candelaria - Servicio de Neurologia

location_facility: (CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques

location_facility: Empire Neurology, PC - Empire Neurology PC

location_facility: Department of Neurology, Haukeland University

location_facility: Azienda Ospadaliero Universitaria San Martino - PARENT

location_facility: SBEI HPE "Saratov State Medical University n.a. V. I. Razumovskiy" of the MoH of the RF

location_facility: Fakultni nemocnice Ostrava - Dept of Neurology

location_facility: Spitalul Clinic Judetean de Urgenta "Pius Branzeu" Timisoara - Clinica de Neurologie II

location_facility: Privatni ordinace - neurologie - Nestatni zdravotnicke zarizeni

location_facility: Universitaetsmedizin Rostock - Klinik und Poliklinik fuer Neurologie

location_facility: Fakultni nemocnice v Motole - Interní klinika 2. LF UK a FN Motol

location_facility: CHU Rennes - Hopital Pontchaillou - Neurologie - Clinique Neurologique

location_facility: Uniwersyteckie Centrum Kliniczne - Dept of Neurology

location_facility: Ospedale Clinicizzato SS. Annunziata - Centro Regionale Sclerosi Multipla

location_facility: Spitalul Clinic Judetean de Urgenta Targu Mures - Sectia Clinica Neurologie I

location_facility: Military Medical Academy - MHAT - Pleven

location_facility: American University of Beirut Medical Center

location_facility: Hopital Roger Salengro - CHU Lille - service de neurologie D

location_facility: Ospedale San Raffaele - U.O. di Neurologia

location_facility: Vseobecna fakultni nemocnice v Praze - Dept of Neurologicka klinika 1.LF UK a VFN v Praze

location_facility: CHU de Nîmes - Hôpital Carémeau - Service de Neurologie

location_facility: Centro Hospitalar de Lisboa Central, E.P.E. - Hospital de Santo António dos Capuchos - Serviço de Neurologia

location_facility: Barmherzige Brueder Konventspital Linz - Abteilung fuer Neurologie

location_facility: Ospedale Sant'Andrea di Roma - MS Center

location_facility: SBHI of Yaroslavl Region "Clinical Hospital # 8" - Cardiology

location_facility: Hôpital Habib Bourguiba - Service de Neurologie

location_facility: Fondazione Istituto Neurologico Casimiro Mondino - Unità Complessa Malattie Cerebrovascolari/Stroke U

location_facility: Azienda Ospedaliero_Universitaria S. Luigi Gonzaga - Centro di Riferimento Regionale Sclerosi Multipla

location_facility: Azienda Ospedaliera San Camillo Forlanini

location_facility: Nottingham University Hospital - Division of Clinical Neurology

location_facility: SBIH of Moscow "City Clinical Hospital # 24" - Branch 1

location_facility: Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari - Neurofisiopatologia

location_facility: SBIH of Moscow region " Moscow Regional Scientific and Research Clinical Institute n.a. M.F. Vladimi

location_facility: Azienda Ospedaliera Universitaria "Federico II" - Gastroenterologia Pediatrica

location_facility: Pavlov First Saint Petersburg State Medical University - PARENT

location_facility: SBIH "Leningrad Regional Clinical Hospital"

location_facility: Krajska zdravotni, a.s. - Nemocnice Teplice, o.z. - Neurologicke oddeleni

location_facility: Saint-Petersburg SU on b.o. City Multifield Hospital #2 - Intensive Pulmonology and Thoracal Surgery

location_facility: RSHI"State Novosibirsk Regional Clinical Hospital"

location_facility: A.O.U. Policlinico V. Emanuele - Presidio Gaspare Rodolico - Clinica Neurologica I

location_facility: Rowan University School of Osteopathic Medicine - Department of Medicine

location_facility: SAIH "Kemerovo Regional Clinical Hospital" - PARENT

location_facility: SBIH "Samara Regional Clinical Hospital n.a. V.D. Seredavin

location_facility: RSBIH "Smolensk Regional Clinical Hospital"

location_facility: Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate)

location_facility: Multiprofile Hospital for Active Treatment - Stara Zagora

location_facility: SEIHPE "Rostov State Medical University of MoH of RF"

location_facility: University of Maryland, Baltimore - Maryland Center for MS

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics - Neurology Clinic

location_facility: Prof. Dr. med. Zbigniew Stelmasiak Specjalistyczny Gabinet Neurologiczny


title: Phase I, Open Label, Multicenter, Dose Escalation Study of CD19-specific CAR-T Cells in Adult Patients With CLL/SLL and DLBCL

summary: This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a CD19-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells will be investigated in combination with ibrutinib in chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and as single agent in diffuse large B-cell lymphoma (DLBCL) and in adult acute lymphoblastic leukemia (ALL).

study_start_date_type: Actual

status: Recruiting

study_completion_date_type: Anticipated

study_type: Interventional

design_allocation: Non-Randomized

primary_purpose: Treatment

enrollment_type: Anticipated

ipd_sharing: No

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
Austria
Australia
United States
France
Japan

location_facility: University of Kansas Cancer Center SC - CTL019C2201

location_facility: H Lee Moffitt Cancer Center and Research Institute

location_facility: University of Chicago Medical Center Hematology and Oncology

location_facility: University of Pennsylvania Clinical Studies Unit Perelman Center for Adv Med

location_facility: Sarah Cannon Research Institute Drug Ship - 4

location_facility: Massachusetts General Hospital Cancer Center

intervention_type: Drug

lead_sponsor_type: industriel

status_simplified: Ongoing


status: Terminated

acronym: DYSTANCE 51

title: A Randomized, Double-blind, Placebo-controlled, Efficacy and Safety Study of WVE-210201 With Open-label Extension in Ambulatory Patients With Duchenne Muscular Dystrophy (DYSTANCE 51)

study_completion_date_type: Actual

lead_sponsor: Wave Life Sciences Ltd.

source: euctr

design_allocation: Randomized

enrollment_type: Actual

location_country:
United Kingdom
Italy
Canada
France
United States
Belgium
Sweden
Czechia

location_facility: Fondazione Policlinico Universitario A Gemelli

location_facility: Drottning Silvias Barn Och Ungdomssjukhus

location_facility: London Health Sciences Centre - Hospital

location_facility: U.O.C di Neurologia e Malattie Neuromuscolari Centro Clinico Nemo Sud

summary: This is a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled study with an open-label extension period to evaluate the safety and efficacy of WVE-210201 (suvodirsen) in ambulatory male pediatric patients with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping intervention (DYSTANCE 51)

status_simplified: Unknown


type: Other Identifier

title: Expanded Access for the Treatment of Cancers With Rearranged During Transfection (RET) Activation

summary:
Expanded access for participants with cancer with RET activation who are ineligible for an ongoing selpercatinib (also known as LOXO-292) clinical trial or have other considerations that prevent access to selpercatinib through an existing clinical trial.

The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.

status: Available

study_type: Expanded Access

lead_sponsor: Loxo Oncology, Inc.

location_country:
Poland
Hong Kong
Spain
Italy
Australia
New Zealand
Switzerland
United States
France
Israel
Singapore
Japan
Germany

location_facility: Azienda Ospedaliero Universitaria Pisana

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

location_facility: University of Chicago Medicine-Comprehensive Cancer Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: ASST Grande Ospedale Metropolitano Niguarda Comitato Etico Milano Area C

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

location_facility: NSW Health - Sydney Local Health District

location_facility: Queensland Health - Metro North Hospital and Health Service

location_facility: Centrum Onkologii Instytut im Marii Curie w Warszawie

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest


ipd_sharing: Yes

status: Completed

primary_purpose: Prevention

intervention_type: Biological

acronym: NTHI MCAT-009

title: Immunogenicity and Safety Study of GSK's Investigational Vaccine (GSK3277511A) When Administered in Healthy Smokers and Ex-smokers Following Receipt of Shingrix Vaccine

lead_sponsor: GlaxoSmithKline

type: EudraCT Number

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

location_country: Spain Italy Estonia Finland France

summary:
This study will provide information regarding the sequential administration of two vaccines adjuvanted with AS01.

The aim of this study is to understand immunogenicity and safety of NTHi-Mcat vaccine when administered sequentially after Shingrix vaccine and to compare to the immunogenicity of NTHi-Mcat vaccine administered alone. This study will also provide information regarding whether a specific time period is required between the administration of these two different vaccines containing the same adjuvant- AS01 components.

The population of this study will include healthy smokers and ex-smokers of 50 to 80 years of age which will be used as a proxy for the COPD population.

status_simplified: Completed


title: A Multi-Center, Low-Interventional Study With a Retrospective Component in Participants With Late-Onset Pompe Disease

summary: The purpose of this study is to obtain information pertaining to the occurrence of antibodies to investigational SPK-3006 capsid and GAA, GAA activity and GAA antigen levels in the usual care setting of Late-Onset Pompe Disease (LOPD) participants on an enzyme replacement regimen. Additionally, a careful evaluation of laboratory and functional testing in patients with LOPD may provide information to better understand the disease features and better drive the design of a future interventional investigational gene therapy trial. An understanding of the underlying status of liver and muscle health in individuals with LOPD may also inform best surveillance during the conduct of gene therapy trials.

primary_purpose: Screening

lead_sponsor: Spark Therapeutics

location_country:
United Kingdom
Italy
Netherlands
United States
France
Germany

location_facility: Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino

location_facility: Universita degli Studi di Milano - Clinica Oculistica I

location_facility: Assistance Publique Hôpitaux de Marseille

location_facility: Università degli Studi di Napoli Federico II

location_facility: Fondazione Mondino Istituto Neurologico Nazionale a Carattere Scientifico

intervention_type: Diagnostic Test


title: An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients With Open Angle Glaucoma or Ocular Hypertension

summary: This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

status: Enrolling by invitation

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.

lead_sponsor: AbbVie

location_country:
Spain
Italy
United Kingdom
United States
Peru
Belgium
Philippines
South Africa
Czechia
Poland
Hong Kong
Russian Federation
Argentina
Israel
Turkey
Singapore
Egypt
Brazil
Canada
Germany
Denmark
New Zealand
Thailand
Korea, Republic of
France
Colombia

location_facility: Klinika Diagnostyki i Mikrochirurgii Jaskry /ID# 240258

location_facility: S. Fyodorov Eye Microsurgery Federal State Institution /ID# 240251

location_facility: Emerson Clinical Research Institute. LLC /ID# 240274

location_facility: Singapore National Eye Centre /ID# 240224

location_facility: Wolstan & Goldberg Eye Associates /ID# 240221

location_facility: Charlotte Eye,Ear,Nose Throat /ID# 240339

location_facility: Internationale Innovative Ophthalmochirurgie /ID# 240232

location_facility: The Chinese University of Hong Kong /ID# 240283

location_facility: Albemarle Clinical Trials LLC /ID# 240219

location_facility: Centrum Diagnostyki i Mikrochirurgii Oka - LENS dr n. med. Slawomir Zalewski /ID# 240248

location_facility: Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 240181

location_facility: Hospital Universitario Reina Sofia /ID# 240322

location_facility: Centre Ophtalmologique Pôle Vision /ID# 240256

location_facility: Glaucoma associates/consultants of the capital region /ID# 240195

location_facility: Hospital Universitario Virgen Macarena /ID# 240325

location_facility: Scott and Christie and Associates /ID# 240189

location_facility: Ain Shams University Hospital /ID# 240338

location_facility: Hospital Clinico Universitario San Carlos /ID# 240303

location_facility: Cambridge University Hospitals NHS Foundation Trust /ID# 240351

location_facility: The Clinical Trials Network (CTNx) /ID# 240284

location_facility: Tel Aviv Sourasky Medical Center /ID# 240311

location_facility: Medical Center Ophthalmology Associates /ID# 240208

location_facility: The Lady Davis Carmel Medical Center /ID# 240293

location_facility: Azienda Ospedaliero Universitaria Pisana-Stabilimento di Santa Chiara /ID# 240301

location_facility: Optinum Profesorskie Centrum Okulistyki /ID# 240307

location_facility: Ophthalmic Consultant Centres /ID# 240205

location_facility: Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240287

location_facility: DCT Shah Eye Research Institut /ID# 240306

location_facility: Arizona Glaucoma Specialists /ID# 240212

location_facility: Seoul National University Hospital /ID# 240262

location_facility: Clinica De Oftalmologia Nova Campinas /ID# 240271

location_facility: Logan Ophthalmic Research Inc. /ID# 240280

location_facility: Hospital de Olhos de Mato Grosso Do Sul /ID# 240276

location_facility: Marmara Universitesi Pendik Egitim ve Arastirma Hastanesi /ID# 240296

location_facility: New York Presbyterian Hospital Weill Cornell Medical Center /ID# 240324

location_facility: Peregrine Eye and Laser Institute /ID# 240260

location_facility: Fundacion Oftalmologica Nacional /ID# 240226

location_facility: Clinica de Oftalmologia Sandiego /ID# 240233

location_facility: Hospital Universitario Austral /ID# 240331

location_facility: A.O.U. Policlinico G. Rodolico S.Marco- Presidio G.Rodolico /ID# 240305

location_facility: Hospital Oftalmologico Medicina dos Olhos /ID# 240277

location_facility: Azienda Ospedaliera di Perugia /ID# 240310

location_facility: Maharaj Nakorn Chiang Mai Hospital /ID# 240194

location_facility: Clinical ophthalmology hospital n.a. V.P. Vihodtsev. /ID# 240253

location_facility: CHU Bordeaux - Hopital Pellegrin /ID# 240316

location_facility: Moorfields Eye Hospital NHS Foundation Trust /ID# 240329

location_facility: Eskisehir Osmangazi University Medical School /ID# 240225

location_facility: International Research Center /ID# 240346

location_facility: Eye Associates of Fort Meyers /ID# 240218

location_facility: Fundacion Oftalmologica de Santander - FOSCAL /ID# 240634

location_facility: Pretoria Eye Institute - Private Practice /ID# 240223

location_facility: Rochester Ophthalmological Group PC /ID# 240290

location_facility: Hamilton Glaucoma Center Shiley Eye Center UCSD /ID# 240196

location_facility: Bostan Diagnostic Eye Center /ID# 240268

location_facility: Clinical Eye Research of Boston LLC /ID# 240203

location_facility: Thammasat University Hospital /ID# 240231

location_facility: Universitair Ziekenhuis Leuven /ID# 240312

location_facility: Universitaetsklinikum Magdeburg /ID# 240314

location_facility: Azienda Sanitaria Locale (ASL) Chieti /ID# 240217

location_facility: Ophthalmic Consultants Long Island /ID# 240211

location_facility: Nature Coast Clinical Research - Crystal River /ID# 240334

location_facility: Centro Oftalmologico Macula Diagnostico and Tratamiento /ID# 240269

location_facility: Hospital das Clinicas da Universidade Federal de Goiás /ID# 240344

location_facility: Eye Associates of New Mexico /ID# 240216

location_facility: Levenson Eye Associates Inc. /ID# 240209

intervention_type: Other


status: Active, not recruiting

title: A Dose-finding Trial Evaluating the Effect and Safety of Once-weekly Treatment of Somapacitan Compared to Daily Norditropin® in Children With Short Stature Born Small for Gestational Age With no Catch-up Growth by 2 Years of Age or Older

lead_sponsor: Novo Nordisk A/S

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

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Japan
Poland
Austria
Russian Federation
India
Israel
Norway
Canada
Switzerland
Hungary
Ireland
Latvia
Estonia
Thailand
Algeria
France

summary:
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe).

Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 4 years. Participants will take either an injection once every week or once every day. Participants will have 9 clinic visits and will be in the study for 1 year. The follow-up period is at least 30 days.


title: A Phase 1 First-in-Human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR441000 Administered Intratumorally as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

summary:
Primary Objectives:

Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options.
Dose Expansion (Combination): To determine the objective response rate of SAR441000 administered intratumorally in combination with cemiplimab in patients with melanoma, cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma.

Secondary Objectives:

To characterize the pharmacokinetic (PK) profile of SAR441000 administered as monotherapy and in combination with cemiplimab.
To assess the immunogenicity of SAR441000.
To characterize the safety of SAR441000 when administered intratumorally in combination with cemiplimab.
To determine the disease control rate (DCR), duration of response (DoR) and progression free survival (PFS) of SAR441000.
To determine the recommended dose of SAR441000 for the expansion phase.

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:
Spain
Netherlands
United States
France
Belgium
Germany

location_facility:
Investigational Site Number :5280001
Investigational Site Number :0560002
Investigational Site Number :7240005
Investigational Site Number :8400001
Investigational Site Number :7240002
Investigational Site Number :8400007
Investigational Site Number :8400002
Investigational Site Number :2760004
Investigational Site Number :2500002
Investigational Site Number :2760001
Investigational Site Number :2760006
Investigational Site Number :0560001
Investigational Site Number :7240001
Investigational Site Number :2760003
Investigational Site Number :2760005
Investigational Site Number :0560003
Investigational Site Number :2500004
Investigational Site Number :8400003
Investigational Site Number :7240004
Investigational Site Number :2500001
Investigational Site Number :5280002


title: A first-time-in Human (FTIH), Phase I/II, Randomized, Multi-centric, Single-blind, Controlled Dose-escalation Study to Evaluate the Reactogenicity, Safety, Immunogenicity and Efficacy of GSK Biologicals' HBV Viral Vector Vaccines Given in a Prime-boost Schedule With Sequential or Co-administration of Adjuvanted Proteins Therapeutic Vaccine (GSK3528869A) in Chronic Hepatitis B Patients (18-65 Years Old) Well Controlled Under Nucleo(s)Tide Analogue (NA) Therapy

summary: A First-Time-In-Human study on GSK's therapeutic vaccines to evaluate the reactogenicity, safety, immunogenicity and efficacy on reduction of serum HBV surface antigen in HBV suppressed subjects under nucleo(s)tide treatment.

location_country:
Taiwan
Hong Kong
Spain
United Kingdom
Thailand
France
Belgium
Germany


acronym: MyCIDPchoice

title: A Multicenter, Randomized, Subject-Blind, Investigator-Blind, Placebo-Controlled, Parallel-Group Study Evaluating the Efficacy, Safety, and Tolerability of Rozanolixizumab in Subjects With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

lead_sponsor: UCB Biopharma S.P.R.L.

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:
Denmark
Spain
United Kingdom
Netherlands
United States
France
Belgium
Germany

summary: The purpose of the study is to evaluate clinical efficacy of rozanolixizumab as a treatment for subjects with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP).


acronym: MAGNOLIA

title: A Phase 2, Open-label Study of Zanubrutinib (BGB-3111) in Patients With Relapsed or Refractory Marginal Zone Lymphoma

lead_sponsor: BeiGene

type: Registry Identifier

ReferenceType: background

ReferenceCitation: Stephen Opat, Robert Marcus, MA, FRCP, FRCPath, Craig A. Portell, MD, William Reed, MD, Chris Tankersley, Jane Huang, MD, Judith Trotman, MBChB, FRACP, FRCPA. Phase 2 Study of Zanubrutinib (BGB-3111) in Patients with Relapsed/Refractory Marginal Zone Lymphoma. Blood. 2019; 134(1):5256. https://doi.org/10.1182/blood-2019-122629

ReferenceCitation: Stephen Opat, et al. Efficacy and Safety of Zanubrutinib in Patients with Relapsed/Refractory Marginal Zone Lymphoma: Initial Results of the MAGNOLIA (BGB-3111-214) Trial. Presented at the 62nd American Society of Hematology (ASH) Annual Meeting, December 5-8, 2020. Abstract 339.

ReferenceCitation: Opat S, Tedeschi A, Linton K, McKay P, Hu B, Chan H, Jin J, Sobieraj-Teague M, Zinzani PL, Coleman M, Thieblemont C, Browett P, Ke X, Sun M, Marcus R, Portell CA, Ardeshna K, Bijou F, Walker P, Hawkes EA, Mapp S, Ho SJ, Talaulikar D, Zhou KS, Co M, Li X, Zhou W, Cappellini M, Tankersley C, Huang J, Trotman J. The MAGNOLIA Trial: Zanubrutinib, a Next-Generation Bruton Tyrosine Kinase Inhibitor, Demonstrates Safety and Efficacy in Relapsed/Refractory Marginal Zone Lymphoma. Clin Cancer Res. 2021 Dec 1;27(23):6323-6332. doi: 10.1158/1078-0432.CCR-21-1704. Epub 2021 Sep 15.

location_country:
United Kingdom
Italy
Australia
New Zealand
United States
France
China
Czechia

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi

location_facility: The First Affiliated Hospital, College of Medicine, Zhejiang University

location_facility: Levine Cancer Institute - Carolinas Medical Center

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

location_facility: Azienda Ospedaliero - Universitaria Maggiore delle Carità

location_facility: Institute of Hematology and Hospital of Blood Disease

summary: This is a single arm study to evaluate the efficacy, safety and tolerability of zanubrutinib (BGB-3111) in participants with relapsed/refractory marginal zone lymphoma (R/R MZL).


title: A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)

summary: Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.

ReferenceType: derived

ReferenceCitation: Hannon CW, McCourt C, Lima HC, Chen S, Bennett C. Interventions for cutaneous disease in systemic lupus erythematosus. Cochrane Database Syst Rev. 2021 Mar 9;3:CD007478. doi: 10.1002/14651858.CD007478.pub2.

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

lead_sponsor: Pfizer

location_country:
Serbia
Spain
Italy
United Kingdom
Ukraine
United States
Romania
Belgium
Japan
Czechia
Poland
Hong Kong
Portugal
Australia
Argentina
Mexico
Canada
Hungary
China
Germany
Bulgaria
Taiwan
Greece
Korea, Republic of
France
Colombia

location_facility: Atlanta Research Center for Rheumatology

location_facility: CNPE "Odesa Regional Clinical Hospital" of Odesa Regional Council

location_facility: Centro Hospitalar Universitario do Porto, E.P.E

location_facility: Centre intégré de santé et de services sociaux du Bas-Saint-Laurent

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Kyungpook National University Hospital (KNUH)

location_facility: Tianjin Medical University General Hospital

location_facility: UAB Department of Medicine Clinical Research Enterprise

location_facility: Klinicki Centar Srbije, Klinika za alergologiju i imunologiju

location_facility: Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V

location_facility: Arthritis and Osteoporosis Medical Center

location_facility: Centro Peninsular de Investigación Clínica S.C.P.

location_facility: Ruijin Hospital- Shanghai Jiaotong University School of Medicine

location_facility: SC Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL

location_facility: Communal non-profitable enterprise "Lviv City Clinical Hospital #4"

location_facility: Vojnomedicinska akademija, Klinika za reumatologiju

location_facility: CHU de Bordeaux, Groupe Hospitalier Sud, Hôpital Haut Lévèque

location_facility: Centro de Investigaciones Medicas Tucuman

location_facility: The First Affiliated Hospital of Soochow University

location_facility: Doncaster Royal Infirmary, Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

location_facility: CNPE "Ternopil University Hospital" of Ternopil regional council, Department of Rheumatology

location_facility: CITER Centro de Investigación y Tratamiento de las Enfermedades Reumáticas S.A. de C.V.

location_facility: Morales Vargas Centro de Investigación S.C.

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

location_facility: Hôpital Pitié Salpêtrière, Centre des Maladies Auto-immunes

location_facility: Laiko General Hospital, University of Athens

location_facility: Arthritis & Rheumatology Center of Oklahoma PLLC

location_facility: Complexo Hospitalario Universitario A Coruna

location_facility: Irving Institute for Clinical and Transitional Research

location_facility: The Leeds Teaching Hospitals NHS Trust, Chapel Allerton Hospital

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

location_facility: Ziekenhuisnetwerk Antwerpen Jan Palfijn (ZNA Jan Palfijn)

location_facility: National Hospital Organization Kyushu Medical Center

location_facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

location_facility: West Broward Rheumatology Associates, Inc

location_facility: Institut Niska Banja, Klinika za Reumatologiju

location_facility: Chang Gung Memorial Hospital Linkou Branch

location_facility: Centrum Medyczne MEDENS S.C. Grupowa Praktyka Lekarska

location_facility: Zakarpattia Regional Clinical Hospital n.a. A. Novak

location_facility: Multifield Medical Center of Odessa National Medical University

location_facility: Guy's and St Thomas' NHS Foundation Trust Guy's Hospital

location_facility: Unidade Local de Saude do Alto Minho, E.P.E.

location_facility: CNPE "Vinnytsya regional Clinical Hospital named after N.I.Pirogov Vinnytsia Regional Council"

location_facility: Békés Megyei Központi Kórház Pándy Kálmán Tagkórház

location_facility: Centro de Investigación en Reumatología y Especialidades Médicas SAS - CIREEM SAS

location_facility: National Hospital Organization Chiba-East Hospital

location_facility: National Hospital Organization Asahikawa Medical Center

location_facility: NYU Langone Ambulatory Care Brooklyn Heights

location_facility: Rheumatic Disease Clinical Research Center, LLC

location_facility: Bluecare Salud S.A.S Sede Centro Médico Integral Chicó MedPlus CRI

location_facility: Investigational Drug Services University of Kansas Hospital

location_facility: Feinstein Institute for Medical Research

location_facility: Narodowy Instytutu Geriatrii, Reumatologii i Rehabilitacji

location_facility: UAB Hospital-Clinical Research Unit (CRU)

location_facility: Inland Rheumatology Clinical Trials, Inc.

location_facility: Zespol Poradni Specjalistycznych Reumed, Onyksowa Filia nr 2

location_facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca

location_facility: East Bay Rheumatology Medical Group, Inc.

location_facility: University General Hospital of Heraklion

location_facility: Universitätsklinikum Schleswig Holstein - Campus Lübeck

location_facility: Hospital Professor Doutor Fernando da Fonseca, E.P.E

location_facility: Investigación y Biomedicina de Chihuahua, Sociedad Civil

location_facility: Centro Integral de Reumatología del Caribe S.A.S - CIRCARIBE S.A.S

location_facility: Inland Rheumatology and Osteoporosis Medical Group

location_facility: State Institution National Scientific Center "M.D. Strazhesko Institute of Cardiology"

location_facility: University of Michigan Brighton Center for Specialty Care

location_facility: Mazowieckie Centrum Reumatologii i Osteoporozy M. Przygodzka Spolka jawna

location_facility: The Second Xiangya Hospital of Central South University


acronym: PRISM

title: PRISM: An Open-label, Multi-Center Extension Study to Investigate the Efficacy and Safety of Cobomarsen (MRG-106) Following Systemic Treatment in Subjects With Cutaneous T-Cell Lymphoma (CTCL), Mycosis Fungoides (MF) Subtype, Who Have Completed the SOLAR Study

lead_sponsor: miRagen Therapeutics, Inc.

location_country:
United States
France
Belgium

location_facility: The Ohio State University and Wexner Medical Center

location_facility: Washington University School of Medicine

location_facility: University of Washington/Seattle Cancer Care Alliance

summary:
The main objective of this clinical trial is to study the efficacy and safety of cobomarsen (also known as MRG-106) for the treatment of cutaneous T-cell lymphoma (CTCL), mycosis fungoides (MF) subtype in subjects who have confirmed disease progression following treatment with vorinostat in the SOLAR clinical study (MRG106-11-201). Cobomarsen is designed to inhibit the activity of a molecule called miR-155 that may be important to the growth and survival of MF cancer cells.

The effects of treatment will be measured based on changes in skin lesion severity, disease-associated symptoms, and quality of life, as well as the length of time that the subject's disease remains stable or improved, without evidence of disease progression. The safety and tolerability of cobomarsen will be assessed based on the frequency and severity of observed side effects.


title: A Phase II, Multicenter, Open-label Study to Investigate the Clinical Efficacy of M7824 Monotherapy in Participants With Locally Advanced or Metastatic Biliary Tract Cancer Who Fail or Are Intolerant to First-line Platinum-Based Chemotherapy

ReferenceType: result

ReferenceCitation: Yoo C, Oh DY, Choi HJ, Kudo M, Ueno M, Kondo S, Chen LT, Osada M, Helwig C, Dussault I, Ikeda M. Phase I study of bintrafusp alfa, a bifunctional fusion protein targeting TGF-β and PD-L1, in patients with pretreated biliary tract cancer. J Immunother Cancer. 2020 May;8(1). pii: e000564. doi: 10.1136/jitc-2020-000564.

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

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

location_facility: Hospital Universitario HM Madrid Sanchinarro - Servicio de Oncologia

location_facility: H. Lee Moffitt Cancer Center and Research Institute, Inc

location_facility: Severance Hospital, Yonsei University Health System

location_facility: Kyorin University Hospital - Dept of Oncology

location_facility: Hospital Universitari Vall d'Hebron - Dept of Oncology

location_facility: Sidney Kimmel Comprehensive Cancer Center at John Hopkins

location_facility: Affiliated Tumor Hospital of Harbin Medical University

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi - Unita' Operativa di Pediatria

location_facility: Kindai University Hospital - Dept of Gastroenterology

location_facility: National Cancer Center Hospital - Dept of Hepatobiliary and Pancreatic Oncology

location_facility: Fondazione IRCCS Istituto Nazionale dei Tumori Milano

location_facility: Policlinico Universitario Agostino Gemelli - UOC Oncologia Medica

location_facility: St James's University Hospital - Dept of Oncology

location_facility: Mayo Clinic in Florida - Department of Neurology

location_facility: Seoul National University Bundang Hospital

location_facility: Groupe Hospitalier Sud - Hôpital Haut Lévêque - Service Hepato Gastroentérologie Oncologie Digest

summary: The study to evaluate M7824 monotherapy in participants with advanced or metastatic biliary tract cancer (BTC) who failed or were intolerant to first-line (1L) chemotherapy.


title: Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early & Advanced Stage Superficial Venous Disease

summary: Global, Post-Market, Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease

lead_sponsor: Medtronic Endovascular

location_country:
Spain
Italy
United Kingdom
Australia
Netherlands
Switzerland
Korea, Republic of
United States
France
Germany

location_facility: New York-Presbyterian Hospital/Weill Cornell Medical Center

location_facility: Bedfordshire Hospitals NHS Foundation Trust

location_facility: Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital

location_facility: Imperial College Healthcare NHS Trust - Charing Cross Hospital

location_facility: Sanitas Hospital Universitario La Zarzuela

location_facility: West London Vascular and Interventional Centre

location_facility: Hôpital de Morges - Ensemble Hospitalier de la Côte

location_facility: Azienda Ospedaliera di Padova Ospendale Sant' Antonio - I piano Day Hospital

location_facility: Complejo Hospitalario Universitario Granada (Hospital Campus de la Salud)

location_facility: Praxis fur Innere Medizin und Gefäβkrankheiten

intervention_type: Procedure


title: A Phase 2a/b, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy, Safety, Tolerability and Pharmacokinetics of KPL-716 in Reducing Pruritus in Subjects With Prurigo Nodularis

summary: Study of the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of Vixarelimab (KPL-716) in subjects with prurigo nodularis.

ipd_sharing: Undecided

lead_sponsor: Kiniksa Pharmaceuticals, Ltd.

location_country:
Poland
Taiwan
United Kingdom
Italy
Austria
Australia
Canada
Korea, Republic of
United States
France
Belgium
Germany
Czechia

location_facility:
Site 1127
Site 108
Site 1102
Site 1308
Site 1301
Site 1307
Site 2302
Site 2504
Site 2201
Site 1150
Site 1309
Site 2503
Site 104
Site 1110
Site 1167
Site 1139
Site 2603
Site 2102
Site 1133
Site 1306
Site 125
Site 4106
Site 2008
Site 2702
Site 2001
Site 4303
Site 2901
Site 2207
Site 123
Site 137
Site 1159
Site 1305
Site 2301
Site 106
Site 1113
Site 4105
Site 2204
Site 1135
Site 1154
Site 2003
Site 2011
Site 1158
Site 1115
Site 4203
Site 4204
Site 1163
Site 4207
Site 101
Site 2701
Site 1302
Site 1116
Site 2903
Site 1166
Site 1151
Site 2101
Site 2002
Site 1107
Site 128
Site 303
Site 117
Site 122
Site 2604
Site 4201
Site 2502
Site 130
Site 4302
Site 1155
Site 105
Site 1118
Site 1121
Site 4304
Site 1132
Site 2005
Site 1165
Site 114
Site 4104
Site 111


acronym: STAND

title: A Phase III, Multicenter, Randomized, Double-blind Study to Assess Efficacy and Safety of Two Doses of Crizanlizumab Versus Placebo, With or Without Hydroxyurea/ Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Vaso-Occlusive Crises (STAND)

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:
Spain
Italy
United Kingdom
United States
Belgium
South Africa
India
Panama
Turkey
Brazil
Lebanon
Canada
Germany
Ghana
Jordan
Greece
Oman
Finland
France
Colombia
Netherlands

summary: The purpose of this study is to compare the efficacy and safety of 2 doses of crizanlizumab (5.0 mg/kg and 7.5 mg/kg) versus placebo in adolescent and adult sickle cell disease (SCD) patients with history of vaso-occlusive crisis (VOC) leading to healthcare visit.


title: An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects With Acute HIT (HITSOVA Study)

acronym: HITSOVA

summary: An Open-Label, Randomised, Active Controlled, Multi-Centre Phase 3 Study to Evaluate the Safety and Efficacy of Danaparoid vs Argatroban in Treatment of Subjects with Acute HIT (HITSOVA study)

lead_sponsor: Aspen Global Incorporated

location_country:
Poland
Bosnia and Herzegovina
Serbia
Italy
Russian Federation
Canada
United States
France
Germany

location_facility: University Hospital Greifswald Dpt. of Hematology

location_facility: Vivantes Klinikum im Friedrichhain Hämophiliezentrum, Gerinnungssprechstunde Landsberger Allee 49

location_facility: Clinical Center University of Sarajevo, Clinic for Lung Diseases

location_facility: Instiute of Cardiovascular Diseases "Dedinje"

location_facility: University Clinical Centre of the Republic of Srpska, Lung Clinic

location_facility: AOU Careggi, SOD Malattie Aterotrombotiche

location_facility: University Clinical Centre of the Republic of Srpska, Clinic for cardiology

location_facility: Clinical centre of Serbia, Clinic for Pulmonology

location_facility: Clinical Center of the Republic of Srpska, Medical Intesnive Care Unit

location_facility: The Institute for Pulmonary Disease of Vojvodina, Pulmonary thromboembolism department

location_facility: Clinical Center University of Sarajevo, Clinic for Heart, Blood Vessels and Rheumatic Diseases

location_facility: Azienda Ospedaliero Universitaria S.Orsola-Malpighi - UO Angiologia e Malattie della Coagulazione

location_facility: Universitätsklinikum Gießen und Marburg GmbH, Klinik für Herz-, Kinderherz- und Gefäßchirurgie Standort Gießen

location_facility: Instituto Scientifico San Raffaele- Servizio Coagulazione e Centro Trombosi

location_facility: Zentrum für Klinische Transfusionsmedizin

location_facility: Wojewódzki Szpital Zespolony im. L. Rydygiera

location_facility: The Ohio State University Wexner Medical Center

location_facility: ASST Papa Giovanni XIII, Servizio di Immunoematologia e Medicina Trasfusionale

location_facility: Clinical Hospital № 122 N. A. L.G. Sokolov

location_facility: The University of Texas MD Anderson Cancer Center

location_facility: Centrum Medyczne HCP Sp. z o.o. Szpital im. Św. Jana Pawła II

location_facility: Centre Hospitalier Universitaire Amiens Picardie

location_facility: Universitatstklinikum Halle (Saale), Medizinische Klinik III

location_facility: First City Hospital N.A. E.E. Volosevich

location_facility: Clinical Centre of Serbia, Clinic for Emergency Internal Medicine


title: A Phase 1/2, Multicenter, Dose-Escalating Study To Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy Of Quizartinib Administered in Combination With Re-Induction Chemotherapy, and as a Single-Agent Continuation Therapy, in Pediatric Relapsed/Refractory AML Subjects Aged 1 Month to <18 Years (and Young Adults Aged up to 21 Years) With FLT3-ITD Mutations

lead_sponsor: Daiichi Sankyo, Inc.

ipd_sharing_description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

location_country:
Denmark
Spain
Italy
United Kingdom
Canada
Sweden
United States
France
Israel
Belgium
Netherlands

location_facility: Washington University School of Medicine

location_facility: NHS Greater Glasgow and Clyde - The Queen Elizabeth University Hospital

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Hospital Infantil Universitario Nino Jesus

location_facility: Prinses Maxima Centrum voor Kinderoncologie

location_facility: University of Minnesota/Masonic Cancer Center

location_facility: University of Mississippi Medical Center

location_facility: Sahlgrenska Universitetssjukhuset - Drottning Silvias Barn- och Ungdomssjukhus

location_facility: Columbia University/Herbert Irving Cancer Center

location_facility: Riley Hospital for Children - Indiana University

location_facility: Schneider Children's Medical Center of Israel

location_facility: The University of Texas Southwestern Medical Center Children's Health

summary:
Quizartinib is an experimental drug. It is not approved for regular use. It can only be used in medical research.

Children or young adults with a certain kind of blood cancer (FLT3-ITD AML) might be able to join this study if it has come back after remission or is not responding to treatment.


title: A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-689 in Patients With Relapsed or Refractory Lymphoma

summary: An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability and PK of HMPL-689 in patients with relapsed or refractory lymphomas

lead_sponsor: Hutchmed

location_country:
Poland
Spain
Italy
Finland
United States
France

location_facility: ICO Badalona - Hospital Universitari Germans Trias i Pujol

location_facility: University of Texas Health Science Center at San Antonio

location_facility: Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego

location_facility: Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

location_facility: Baylor Scott and White Research Institute

location_facility: Ventura County Hematology-Oncology Specialists

location_facility: ICO l'Hospitalet - Hospital Duran i Reynals

location_facility: Winship Cancer Institute of Emory University


title: An International, Phase 3, Multicenter, Randomized, Open- Label Trial Comparing Balixafortide in Combination With Eribulin Versus Eribulin Alone in Patients With HER2 Negative, Locally Recurrent or Metastatic Breast Cancer

acronym: FORTRESS

summary: This is a phase 3, multicenter, open-label, randomized active-controlled, parallel group to investigate the efficacy, safety and tolerability of intravenous balixafortide given with eribulin versus eribulin alone in the treatment of HER2 negative, Locally Recurrent or Metastatic Breast Cancer.

status: Unknown status

lead_sponsor: Polyphor Ltd.

location_country:
Taiwan
Brazil
Spain
Italy
Russian Federation
United Kingdom
Argentina
Ukraine
Korea, Republic of
United States
France
Belgium
Czechia

location_facility: Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda

location_facility: Krasnoyarsk Regional Oncology Center n.a. A.I. Kryzhanovskiy

location_facility: Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

location_facility: Florida Cancer Specialists NORTH - SCRI - PPDS

location_facility: Hospital Clinico Universitario de Valencia

location_facility: Liga Paranaense de Combate Ao Cancer - Hospital Erasto Gaertner

location_facility: Budgetary Healthcare Institution of the Omsk region "Clinical Oncology Dispensary"

location_facility: ASST di Monza - Azienda Ospedaliera San Gerardo

location_facility: Saint Luke's Cancer Institute 150 Entrance

location_facility: Universidade de Caxias do Sul (IPCEM-UCS)

location_facility: Florida Cancer Specialists PAN - SCRI - PPDS

location_facility: CHIREC Centre Hospitalier Interregional Edith Cavell

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

location_facility: Koo Foundation Sun Yat-Sen Cancer Center

location_facility: OHSU Knight Cancer Institute Hematology Oncology

location_facility: Centro Polivalente de Asistencia e Investigación Clínica - CER San Juan

location_facility: Azienda Ospedaliera Universitaria - Università degli studi della Campania "Luigi Vanvitelli"

location_facility: Florida Cancer Specialists SOUTH - SCRI - PPDS

location_facility: CNCE of Lviv Regional Council Lviv Oncological Regional Therapeutical and Diagnostic Centre

location_facility: LLC Medical Center Family Medicine Clinic

location_facility: Hospital General Universitario Gregorio Marañon

location_facility: Municipal Institution SubCarpathian Clinical Oncological Centre

location_facility: Florida Cancer Specialists EAST - SCRI - PPDS

location_facility: Herbert-Herman Cancer Center, Sparrow Hospital

location_facility: Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

location_facility: Municipal Institution City Clinical Hospital #4 of Dnipro City Council - PPDS

location_facility: CAIPO Centro para la atención integral del paciente oncológico

location_facility: Volgograd Regional Clinical Oncology Dispensary

location_facility: California Cancer Associates for Research and Excellence

location_facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

location_facility: Centro de Investigación Clínica - Clínica Viedma

location_facility: Research Oncology Institute of Tomsk Scientific Center

location_facility: Hospital de Base Da Faculdade de Medicina de São José Do Rio Preto

location_facility: Hospital Universitario Germans Trias i Pujol


title: Mepolizumab Long-term Access Programme for Subjects Who Participated in Study MEA115921 (Placebo-controlled Study of Mepolizumab in the Treatment of Eosinophilic Granulomatosis With Polyangiitis in Subjects Receiving Standard-of-care Therapy)

summary: Eosinophilic Granulomatosis with Polyangiitis (EGPA), also referred to as Churg-Strauss syndrome, is a rare hyper-eosinophilic syndrome. Eosinophilia is central to the pathophysiology of EGPA and interleukin-5 (IL-5) is a key cytokine regulating the life-cycle of the eosinophil. Neutralization of IL-5 with mepolizumab, an anti-IL5 monoclonal antibody, therefore offers a potential therapeutic option for EGPA. The objective of study MEA115921 was to investigate the efficacy and safety of mepolizumab compared with placebo wherein the subjects were randomized to receive either: 300 milligram (mg) mepolizumab or Placebo subcutaneous (SC) injection every 4 weeks in addition to their background standard-of-care therapy. Subjects were treated for a period of 52 weeks and then followed up for a further 8 weeks to study completion at Week 60. This is a LAP to support provision of open-label mepolizumab on an individual basis to eligible subjects who participated in clinical study MEA115921 and who require a dose of prednisolone (or equivalent) of >=5 milligrams per day (mg/day) for adequate control of their EGPA. Eligible subjects can initiate mepolizumab under this LAP within a 6-month period starting from completion of study MEA115921 (that is, at Week 60) or, in case of premature discontinuation from study MEA115921, the subjects will initiate mepolizumab at the time point that would have been Week 60 if the subject had completed the study. Eligible subjects will receive subcutaneously administered mepolizumab at a dose of 300 mg SC every 4 weeks. Eligible subjects will continue to receive mepolizumab under this LAP until mepolizumab is commercially licensed for the treatment of EGPA in the relevant country or until GlaxoSmithKline (GSK) discontinues the program or until the subject meets any of the withdrawal/stopping criteria.

location_country:
United Kingdom
Canada
United States
France
Belgium
Japan
Germany


title: Randomized, Open Label, Multicenter Study Assessing The Clinical Benefit Of Isatuximab Combined With Carfilzomib (Kyprolis®) And Dexamethasone Versus Carfilzomib With Dexamethasone In Patients With Relapse And/Or Refractory Multiple Myeloma Previously Treated With 1 to 3 Prior Lines

acronym: IKEMA

summary:
Primary Objective:

To demonstrate the benefit of isatuximab in combination with carfilzomib and dexamethasone in the prolongation of Progression Free Survival (PFS) as compared to carfilzomib and dexamethasone in patients with relapsed and/or refractory multiple myeloma (MM) previously treated with 1 to 3 lines of therapy.

Secondary Objectives:

To evaluate the Overall Response Rate (ORR), rate of very good partial response (VGPR) or better and complete response (CR) rate in both arms using International Myeloma Working Group (IMWG) criteria.
To evaluate rate of VGPR or better with minimal residual disease (MRD) negativity in both arms using IMWG criteria.
To evaluate the Overall Survival (OS) in both arms.
To evaluate safety in both arms.
To evaluate duration of response (DOR) in both arms.
To evaluate the Time To Progression (TTP) in both arms.
To evaluate the Second Progression Free Survival (PFS2) in both arms.
To evaluate the Time to first response
To evaluate the Time to best response
To determine the Pharmacokinetic profile of isatuximab in combination with carfilzomib.
To evaluate the immunogenicity of isatuximab in isatuximab arm.
To assess disease-specific and generic health-related quality of life (HRQL), disease and treatment-related symptoms, health state utility, and health status in both arms.

ReferenceCitation: Moreau P, Dimopoulos MA, Mikhael J, Yong K, Capra M, Facon T, Hajek R, Špička I, Baker R, Kim K, Martinez G, Min CK, Pour L, Leleu X, Oriol A, Koh Y, Suzuki K, Risse ML, Asset G, Macé S, Martin T; IKEMA study group. Isatuximab, carfilzomib, and dexamethasone in relapsed multiple myeloma (IKEMA): a multicentre, open-label, randomised phase 3 trial. Lancet. 2021 Jun 19;397(10292):2361-2371. doi: 10.1016/S0140-6736(21)00592-4. Epub 2021 Jun 4.

ReferenceCitation: Moreau P, Dimopoulos MA, Yong K, Mikhael J, Risse ML, Asset G, Martin T. Isatuximab plus carfilzomib/dexamethasone versus carfilzomib/dexamethasone in patients with relapsed/refractory multiple myeloma: IKEMA Phase III study design. Future Oncol. 2020 Jan;16(2):4347-4358. doi: 10.2217/fon-2019-0431. Epub 2019 Dec 13.

location_country:
Brazil
Spain
Greece
Italy
Australia
New Zealand
Canada
Russian Federation
United Kingdom
Hungary
Korea, Republic of
United States
France
Turkey
Japan
Czechia

location_facility:
Investigational Site Number 3480005
Investigational Site Number 6430002
Investigational Site Number 7920002
Investigational Site Number 2500002
Investigational Site Number 0360006
Investigational Site Number 0760005
Investigational Site Number 8400003
Investigational Site Number 5540002
Investigational Site Number 2030001
Investigational Site Number 7920004
Investigational Site Number 2500003
Investigational Site Number 4100006
Investigational Site Number 3800002
Investigational Site Number 4100002
Investigational Site Number 3920002
Investigational Site Number 7920003
Investigational Site Number 0360005
Investigational Site Number 3480004
Investigational Site Number 2500001
Investigational Site Number 6430004
Investigational Site Number 3000002
Investigational Site Number 3920003
Investigational Site Number 0360008
Investigational Site Number 1240003
Investigational Site Number 2500006
Investigational Site Number 2500005
Investigational Site Number 0360007
Investigational Site Number 0760003
Investigational Site Number 8260004
Investigational Site Number 3920001
Investigational Site Number 7920001
Investigational Site Number 0360002
Investigational Site Number 3920005
Investigational Site Number 5540001
Investigational Site Number 3920007
Investigational Site Number 4100004
Investigational Site Number 1240001
Investigational Site Number 3000005
Investigational Site Number 3000004
Investigational Site Number 6430003
Investigational Site Number 3920004
Investigational Site Number 7240003
Investigational Site Number 7240001
Investigational Site Number 3000003
Investigational Site Number 8400002
Investigational Site Number 0760002
Investigational Site Number 0760004
Investigational Site Number 2500004
Investigational Site Number 3000001
Investigational Site Number 3480001
Investigational Site Number 2030003
Investigational Site Number 3800003
Investigational Site Number 0360001
Investigational Site Number 4100005
Investigational Site Number 0360004
Investigational Site Number 4100001
Investigational Site Number 7920005
Investigational Site Number 2030002
Investigational Site Number 3800004
Investigational Site Number 3920006
Investigational Site Number 2030004
Investigational Site Number 1240002
Investigational Site Number 0760001
Investigational Site Number 7240002
Investigational Site Number 8260005
Investigational Site Number 3480003
Investigational Site Number 3800001
Investigational Site Number 7240004
Investigational Site Number 8260001
Investigational Site Number 7240005


title: A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults With Cystic Fibrosis

summary:
Part 1 of this trial will enroll healthy volunteers into a single ascending dose (SAD), multiple ascending dose (MAD), and Food Effect (FE) treatment groups.

The SAD treatment group is comprised of at least 3 ascending dose level cohorts where healthy adult subjects will be randomized to receive a single dose of either PTI-808 or placebo and will be followed for 7 days post dose. A safety review committee (SRC) will convene after the completion of each cohort to evaluate safety and pharmacokinetic (PK) data.

Following the conclusion of the respective SAD level dose groups and after sufficient review of study data and approval by the SRC, a second set of healthy adult subjects will participate in an assigned MAD treatment group. The MAD treatment group is comprised of 3 ascending dose level cohorts where subjects will be randomized to receive either PTI-808 or placebo daily for 7 days and will be followed for 7 days after receiving the last dose.

Also following the conclusion of the respective SAD level dose groups, healthy adult subjects will participate in the FE treatment group.

Part 2 of this will enroll healthy volunteers to assess the safety, tolerability, and PK of PTI 808 co administered with PTI 801 and PTI 428 to HVs with daily dosing for 7 consecutive days.

Part 3 will enroll adult subjects with cystic fibrosis (CF) into a MAD treatment group consisting of 2 cohorts. Subjects will receive PTI-808 co-administered with PTI-801 and PTI-428. PTI-808 will be administered daily for 7 consecutive days followed by PTI-808 + PTI-801 + PTI-428 administered daily for 14 consecutive days.

Part 4 will enroll adult subjects with cystic fibrosis (CF) into 28-day cohorts. Subjects will receive PTI-808 co-administered with PTI-801 with or without PTI-428 versus matching placebo.

lead_sponsor: Proteostasis Therapeutics, Inc.

location_country:
Denmark
United Kingdom
Australia
New Zealand
Canada
United States
France
Belgium
Germany

location_facility: University of North Carolina at Chapel Hill

location_facility: Michigan Medicine, University of Michigan

location_facility: Banner University of Arizona Medical Center

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

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

location_facility: Hôpital Maison Blanche Maladies respiratoires et allergologie


title: A Pivotal, Double-Blind, Randomized, Placebo-Controlled, Multinational Study of SGX942 (Dusquetide) for the Treatment of Oral Mucositis in Patients Being Treated With Concomitant Chemoradiation for the Treatment of Squamous Cell Carcinoma of the Head and Neck

summary: To assess the efficacy of SGX942 compared to placebo in decreasing the duration of severe oral mucositis in patients receiving chemoradiation treatment for the treatment of head and neck cancer

ReferenceCitation: North JR, Takenaka S, Rozek A, Kielczewska A, Opal S, Morici LA, Finlay BB, Schaber CJ, Straube R, Donini O. A novel approach for emerging and antibiotic resistant infections: Innate defense regulators as an agnostic therapy. J Biotechnol. 2016 May 20;226:24-34. doi: 10.1016/j.jbiotec.2016.03.032. Epub 2016 Mar 23.

ReferenceCitation: Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Elder J, Sonis ST, Straube R, Donini O. Dusquetide: A novel innate defense regulator demonstrating a significant and consistent reduction in the duration of oral mucositis in preclinical data and a randomized, placebo-controlled phase 2a clinical study. J Biotechnol. 2016 Dec 10;239:115-125. doi: 10.1016/j.jbiotec.2016.10.010. Epub 2016 Oct 13.

ReferenceCitation: Kudrimoti M, Curtis A, Azawi S, Worden F, Katz S, Adkins D, Bonomi M, Scott Z, Elder J, Sonis ST, Straube R, Donini O. Dusquetide: Reduction in oral mucositis associated with enduring ancillary benefits in tumor resolution and decreased mortality in head and neck cancer patients. Biotechnol Rep (Amst). 2017 May 17;15:24-26. doi: 10.1016/j.btre.2017.05.002. eCollection 2017 Sep.

lead_sponsor: Soligenix

location_country:
United Kingdom
Spain
United States
France
Belgium

location_facility: Hospital Clínico Universitario Lozano Blesa

location_facility: University of Iowa Hospitals and Clinics

location_facility: Hospital Regional Universitario de Málaga

location_facility: Spartanburg Regional-Gibbs Cancer Center

location_facility: Des Moines Oncology Research Association

location_facility: Centre Hospitalier Universitaire de Mons

location_facility: University of Missouri-Ellis Fischel Cancer Center


title: Personalized CRT - Multiple Point Pacing Post Approval Study

summary: The purpose of this Post-Approval Study (PAS) is to evaluate the effectiveness of MPP to improve CRT response in the non-responder patient population when used in "real-world" clinical practice, following commercial release. This evaluation is based on the Clinical Composite Score which summarizes the proportions and frequencies of CRT non-responder patients who are "improved", "unchanged" or "worsened" after receiving MPP therapy. Patients will be followed for the duration of the PAS. This study is required by FDA as a condition of approval of the MPP feature and is integrated within the Product Surveillance Registry (PSR).

study_type: Observational

time_perspective: Prospective

lead_sponsor: Medtronic

location_country:
Spain
Italy
United Kingdom
Netherlands
Canada
Hungary
Korea, Republic of
United States
France
Malaysia
Belgium
Germany
Slovakia

location_facility: Institut de cardiologie et de pneumologie de Québec (IUCPQ)

location_facility: Washington University School of Medicine

location_facility: Institut Jantung Negara - National Heart Institute

location_facility: University Hospitals of Birmingham NHS Foundation Trust - Queen Elizabeth Hospital

location_facility: Liverpool Heart and Chest Hospital NHS Foundation Trust

location_facility: Vychodoslovensky ustav srdcovych a cievnych chorob, a.s.

location_facility: Northeast Ohio Cardiovascular Specialists

location_facility: Azienda Ospedaliera Ospedale Niguarda Cà Granda

location_facility: Central Manchester University Hospitals NHS - Manchester Royal Infirmary

location_facility: Hospital General Universitario Gregorio Maranon

location_facility: CHU de Montpellier - Hôpital Arnaud de Villeneuve

location_facility: Mercy Health - Saint Vincent Medical Center

location_facility: Centre hospitalier de la région d'Annecy

location_facility: Texas Cardiac Arrhythmia Research Foundation

location_facility: Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen

location_facility: Complejo Hospitalario Universitario de Santiago de Compostela

location_facility: CHRU Brest - Hôpital de la Cavale Blanche

location_facility: The James Cook University Hospital - South Tees Hospitals NHS

location_facility: The University of Vermont Medical Center

location_facility: North Memorial Heart and Vascular Institute

location_facility: Centre Hospitalier Universitaire de Clermont-Ferrand - Gabriel-Montpied

intervention_type: Device


title: A Phase III Randomised Controlled Trial of Continuous Beta-lactam Infusion Compared With Intermittent Beta-lactam Dosing in Critically Ill Patients

acronym: BLING III

summary:
The purpose of this study is to find out whether continuous infusion of beta-lactam antibiotics or intermittent infusion or beta-lactam antibiotics, offers more health advantages to patients or if there is no difference.

The investigators will be looking to see whether patients receiving beta-lactams via one administration method or the other have a better chance of recovering from their illness. They will also be looking at long term outcomes such as quality-of-life and healthcare resource use.

Sepsis is caused by toxic substances (toxins) from bacteria and other organism entering the bloodstream from a site of infection. In some people, the infection can progress to sepsis and septic shock where the functions of organs in the body are affected. Patients suffering from sepsis and septic shock are commonly managed in the intensive care unit (ICU) where they are prescribed antibiotics as standard therapy, as well as other therapies to support the functions of the body.

Beta-lactam antibiotics are a group of antibiotics commonly used to treat infection in patients with sepsis and septic shock.

Currently, beta-lactam antibiotics are most commonly given to patients be intermittent infusions, that is, given at regular intervals throughout 24 hours. New research suggests that giving beta-lactam antibiotics as a continuous infusion may mean that antibiotic concentrations in the blood remain more consistent and may be more effective at killing bacteria.

However, the benefit to the patient by giving beta-lactams via continuous infusion has not been tested in a high-quality, large clinical trial.

ReferenceCitation: Lipman J, Brett SJ, De Waele JJ, Cotta MO, Davis JS, Finfer S, Glass P, Knowles S, McGuinness S, Myburgh J, Paterson DL, Peake S, Rajbhandari D, Rhodes A, Roberts JA, Shirwadkar C, Starr T, Taylor C, Billot L, Dulhunty JM. A protocol for a phase 3 multicentre randomised controlled trial of continuous versus intermittent β-lactam antibiotic infusion in critically ill patients with sepsis: BLING III. Crit Care Resusc. 2019 Mar;21(1):63-68.

ipd_sharing_description: Yet to be decided

lead_sponsor: The George Institute

location_country:
United Kingdom
Australia
New Zealand
Sweden
France
Belgium
Malaysia

location_facility: James Cook University Hospital South Tees

location_facility: Northumbria Specialist Emergency Hospital

location_facility: University Hospital Coventry & Warwickshire

location_facility: Basingstoke and North Hampshire Hospital


title: A Phase III Randomized, Placebo-Controlled, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Combination With Glucocorticoid Treatment Compared to Glucocorticoid Monotherapy in Adults With Giant Cell Arteritis

summary: To investigate the safety and efficacy of abatacept with steroid treatment in comparison to steroid treatment alone in up to a 28 week taper of steroid treatment to sustain remission of Giant Cell Arteritis in adults.

study_start_date_type: Anticipated

status: Withdrawn

lead_sponsor: Bristol-Myers Squibb

location_country:
Serbia
Spain
Italy
United Kingdom
United States
Romania
Belgium
Poland
Austria
Australia
Sweden
Canada
Switzerland
Germany
Bulgaria
Denmark
Greece
Ireland
Estonia
France
Netherlands


title: A Phase 1/1b First-in-human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR439459 Administered Intravenously as Monotherapy and in Combination With Cemiplimab in Adult Patients With Advanced Solid Tumors

summary:
Primary Objectives:

Dose escalation (Part 1)

Part 1A (SAR439459 monotherapy)

To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with advanced solid tumors.

Part 1B (SAR439459 and cemiplimab combination therapy)

To determine the MTD and/or MAD of SAR439459 administered intravenously in combination with cemiplimab administered intravenously in adult patients with advanced solid tumors.

Dose expansion (Part 2)

Part 2A (SAR439459 monotherapy)

To determine optimal dose of SAR439459 administered intravenously in adult patients with advanced melanoma who have failed a prior therapy based on anti-PD-1 (programmed cell death-1) or anti-PD-L1.

Part 2B (SAR439459 and cemiplimab combination therapy)

To determine the objective response rate (ORR) of SAR439459 in combination with cemiplimab in adult patients with selected advanced solid tumors by evaluation of antitumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1).

Secondary Objectives:

Pharmacokinetic (PK) profile SAR439459 monotherapy and combined with cemiplimab, PK profile of cemiplimab combined with SAR439459.
Immunogenicity of SAR439459 monotherapy and combined with cemiplimab.

Dose escalation (Part 1)

Overall safety/tolerability profile of SAR439459 monotherapy and combined with cemiplimab.
Preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy or combined with cemiplimab.

Dose expansion (Part 2)

Progression free survival (PFS), time to progression (TTP), ORR, and safety of SAR439459 as monotherapy and PFS, TTP, duration of response (DOR), disease control rate (DCR) and safety in combination with cemiplimab.
To confirm the optimal dose of SAR439459 administered in combination with cemiplimab.

ReferenceCitation: Greco R, Qu H, Qu H, Theilhaber J, Shapiro G, Gregory R, Winter C, Malkova N, Sun F, Jaworski J, Best A, Pao L, Hebert A, Levit M, Protopopov A, Pollard J, Bahjat K, Wiederschain D, Sharma S. Pan-TGFβ inhibition by SAR439459 relieves immunosuppression and improves antitumor efficacy of PD-1 blockade. Oncoimmunology. 2020 Sep 13;9(1):1811605. doi: 10.1080/2162402X.2020.1811605.

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

location_facility:
Investigational Site Number :8400101
Investigational Site Number :5280001
Investigational Site Number :2500005
Investigational Site Number :3800001
Investigational Site Number :2500006
Investigational Site Number :5280005
Investigational Site Number :8400004
Investigational Site Number :7240003
Investigational Site Number :0560002
Investigational Site Number :3800003
Investigational Site Number :2500003
Investigational Site Number :8400001
Investigational Site Number :7240005
Investigational Site Number :7240002
Investigational Site Number :0360002
Investigational Site Number :8400007
Investigational Site Number :1580002
Investigational Site Number :8400006
Investigational Site Number :8260001
Investigational Site Number :2500002
Investigational Site Number :2760001
Investigational Site Number :0360001
Investigational Site Number :1240001
Investigational Site Number :1580001
Investigational Site Number :0560001
Investigational Site Number :3800002
Investigational Site Number :4100002
Investigational Site Number :7240006
Investigational Site Number :7240001
Investigational Site Number :2760003
Investigational Site Number :1240002
Investigational Site Number :2500004
Investigational Site Number :1240003
Investigational Site Number :2330001
Investigational Site Number :4100001
Investigational Site Number :8400003
Investigational Site Number :7240004
Investigational Site Number :2500001
Investigational Site Number :8400008
Investigational Site Number :1580003
Investigational Site Number :8260002
Investigational Site Number :5280002


title: A Global Epidemiologic Study to Determine the Prevalence of Neutralizing Antibodies and Related Adaptive Immune Responses to Adeno-Associated Virus (AAV) in Adults With Hemophilia

summary: Assess the seroprevalence of neutralizing antibodies (NAb) to AAV in adults with severe hemophilia A (coagulation factor VIII [FVIII] <1%) or moderately severe to severe hemophilia B (coagulation factor IX [FIX] ≤2%).

ipd_sharing_description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

lead_sponsor: Baxalta now part of Shire

location_country:
Spain
Italy
Austria
United States
France
Germany

location_facility: Groupement Hospitalier Sud - Hôpital Bicêtre

location_facility: Hospital Regional Universitario de Malaga

location_facility: Medical University of South Carolina (MUSC)

location_facility: Cincinnati Children's Hospital Medical Center

location_facility: Azienda Ospedaliera Universitaria Careggi

location_facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

location_facility: Gulf States Hemophilia and Thrombophilia Center

location_facility: University of Colorado Hemophilia & Thrombosis Center

location_facility: Groupement Hospitalier Est- Hôpital Louis Pradel

location_facility: Klinikum der Johann Wolfgang Goethe-Universitaet

location_facility: Presidio Ospedaliero di Castelfranco Veneto


title: A Double-blind, Randomized, Psychoactive Placebo-controlled, Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (28 mg, 56 mg and 84 mg) of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Pediatric Subjects Assessed to be at Imminent Risk for Suicide

lead_sponsor: Janssen Research & Development, LLC

location_country:
Poland
Brazil
Spain
Italy
Hungary
France
United States
Belgium
Bulgaria

location_facility: Dzieciecy Szpital Kliniczny im. Jozefa Polikarpa Brudzinskiego

location_facility: Vadaskert Gyermek- és Ifjúságpszichiátriai Kórház és Szakambulancia

location_facility: Azienda Ospedaliera Universitaria Federico II

location_facility: University North Carolina at Chapel Hill

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: IRCCS C. Mondino, Istituto Neurologico Nazionale, Fondazione

location_facility: University of Iowa, Carver College of Medicine

location_facility: Trial Tech Tecnologia em Pesquisas com Medicamentos

location_facility: Multiprofile Hospital for Active Treatment - MHAT Sveta Marina EAD

location_facility: University of Texas Southwestern Medical Center

location_facility: Hospital Universitario Professor Edgar Santos

location_facility: Azienda Ospedaliera Universitaria Policlinico G. Martino

location_facility: Klinika Psychiatrii Dzieci i Mlodziezy, CM UJ

location_facility: Instytut Psychiatrii i Neurologii Klinika Psychiatrii Dzieci i Mlodziezy

summary: The purpose of this study is to assess the efficacy of a single (first) dose of 3 fixed doses of intranasal esketamine {28 milligram (mg), 56 mg, and 84 mg} compared with psychoactive placebo (oral midazolam) in rapidly reducing the symptoms of major depressive disorder (MDD) including suicidal ideation in participants 12 to less than 18 years of age who are assessed to be at imminent risk for suicide.


title: A Phase 1/2 Study of Oral Selpercatinib (LOXO-292) in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001)

summary: This is an open-label, first-in-human study designed to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity of selpercatinib (also known as LOXO-292) administered orally to participants with advanced solid tumors, including rearranged during transfection (RET)-fusion-positive solid tumors, medullary thyroid cancer (MTC) and other tumors with RET activation.

ReferenceCitation: Subbiah V, Wolf J, Konda B, Kang H, Spira A, Weiss J, Takeda M, Ohe Y, Khan S, Ohashi K, Soldatenkova V, Szymczak S, Sullivan L, Wright J, Drilon A. Tumour-agnostic efficacy and safety of selpercatinib in patients with RET fusion-positive solid tumours other than lung or thyroid tumours (LIBRETTO-001): a phase 1/2, open-label, basket trial. Lancet Oncol. 2022 Oct;23(10):1261-1273. doi: 10.1016/S1470-2045(22)00541-1. Epub 2022 Sep 12.

ReferenceCitation: Rolfo C, Hess LM, Jen MH, Peterson P, Li X, Liu H, Lai Y, Sugihara T, Kiiskinen U, Vickers A, Summers Y. External control cohorts for the single-arm LIBRETTO-001 trial of selpercatinib in RET+ non-small-cell lung cancer. ESMO Open. 2022 Aug;7(4):100551. doi: 10.1016/j.esmoop.2022.100551. Epub 2022 Aug 2.

ReferenceCitation: Subbiah V, Gainor JF, Oxnard GR, Tan DSW, Owen DH, Cho BC, Loong HH, McCoach CE, Weiss J, Kim YJ, Bazhenova L, Park K, Daga H, Besse B, Gautschi O, Rolfo C, Zhu EY, Kherani JF, Huang X, Kang S, Drilon A. Intracranial Efficacy of Selpercatinib in RET Fusion-Positive Non-Small Cell Lung Cancers on the LIBRETTO-001 Trial. Clin Cancer Res. 2021 Aug 1;27(15):4160-4167. doi: 10.1158/1078-0432.CCR-21-0800. Epub 2021 Jun 4.

ReferenceCitation: Wirth LJ, Sherman E, Robinson B, Solomon B, Kang H, Lorch J, Worden F, Brose M, Patel J, Leboulleux S, Godbert Y, Barlesi F, Morris JC, Owonikoko TK, Tan DSW, Gautschi O, Weiss J, de la Fouchardière C, Burkard ME, Laskin J, Taylor MH, Kroiss M, Medioni J, Goldman JW, Bauer TM, Levy B, Zhu VW, Lakhani N, Moreno V, Ebata K, Nguyen M, Heirich D, Zhu EY, Huang X, Yang L, Kherani J, Rothenberg SM, Drilon A, Subbiah V, Shah MH, Cabanillas ME. Efficacy of Selpercatinib in RET-Altered Thyroid Cancers. N Engl J Med. 2020 Aug 27;383(9):825-835. doi: 10.1056/NEJMoa2005651.

ReferenceCitation: Drilon A, Oxnard GR, Tan DSW, Loong HHF, Johnson M, Gainor J, McCoach CE, Gautschi O, Besse B, Cho BC, Peled N, Weiss J, Kim YJ, Ohe Y, Nishio M, Park K, Patel J, Seto T, Sakamoto T, Rosen E, Shah MH, Barlesi F, Cassier PA, Bazhenova L, De Braud F, Garralda E, Velcheti V, Satouchi M, Ohashi K, Pennell NA, Reckamp KL, Dy GK, Wolf J, Solomon B, Falchook G, Ebata K, Nguyen M, Nair B, Zhu EY, Yang L, Huang X, Olek E, Rothenberg SM, Goto K, Subbiah V. Efficacy of Selpercatinib in RET Fusion-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2020 Aug 27;383(9):813-824. doi: 10.1056/NEJMoa2005653.

lead_sponsor: Loxo Oncology, Inc.

location_country:
Denmark
Taiwan
Hong Kong
Spain
Italy
United Kingdom
Australia
Canada
Switzerland
Korea, Republic of
United States
France
Israel
Singapore
Japan
Germany

location_facility: University of Wisconsin-Madison Hospital and Health Clinic

location_facility: Institut du Cancer de Montpellier - Val d'aurelle

location_facility: University of Texas Southwestern Medical Center at Dallas

location_facility: Soroka Medical Center - Pediatric Outpatient Clinic

location_facility: Hospital Universitario Fundación Jiménez Díaz

location_facility: Sarah Cannon Research Institute at HealthOne

location_facility: Severance Hospital, Yonsei University Health System

location_facility: University of Chicago Medicine-Comprehensive Cancer Center

location_facility: University of Texas MD Anderson Cancer Center

location_facility: National Hospital Organization Kyushu Cancer Center

location_facility: Institut Bergonié - Centre Régional de Lutte Contre Le Cancer de Bordeaux et Sud Ouest

location_facility: Seoul National University Bundang Hospital


title: A 52-Week Multicenter, Randomized, Open-Label, Parallel- Group Study Evaluating the Efficacy and Safety of Ixekizumab Versus Adalimumab in Patients With Psoriatic Arthritis Who Are Biologic Disease-Modifying Anti-Rheumatic Drug Naive

lead_sponsor: Eli Lilly and Company

ReferenceCitation: Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.

ReferenceCitation: Elewski BE, Blauvelt A, Gallo G, Wolf E, McKean-Matthews M, Burge R, Merola JF, Gottlieb AB, Guenther LC. Simultaneous Nail and Skin Clearance in Ixekizumab Head-to-Head Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Dermatol Ther (Heidelb). 2022 Apr;12(4):911-920. doi: 10.1007/s13555-022-00704-2. Epub 2022 Mar 13.

ReferenceCitation: Smolen JS, Sebba A, Ruderman EM, Schulze-Koops H, Sapin C, Gellett AM, Sprabery AT, Li L, de la Torre I, Gallo G, Liu-Leage S, Pillai S, Reis P, Nash P. Efficacy and Safety of Ixekizumab with or Without Methotrexate in Biologic-Naïve Patients with Psoriatic Arthritis: 52-Week Results from SPIRIT-H2H Study. Rheumatol Ther. 2020 Dec;7(4):1021-1035. doi: 10.1007/s40744-020-00250-3. Epub 2020 Nov 16.

ReferenceCitation: Smolen JS, Mease P, Tahir H, Schulze-Koops H, de la Torre I, Li L, Hojnik M, Sapin C, Okada M, Caporali R, Gratacós J, Goupille P, Liu Leage S, Pillai S, Nash P. Multicentre, randomised, open-label, parallel-group study evaluating the efficacy and safety of ixekizumab versus adalimumab in patients with psoriatic arthritis naïve to biological disease-modifying antirheumatic drug: final results by week 52. Ann Rheum Dis. 2020 Oct;79(10):1310-1319. doi: 10.1136/annrheumdis-2020-217372. Epub 2020 Jul 13.

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.

location_country:
Spain
Italy
United Kingdom
Ukraine
South Africa
Belgium
Poland
Austria
Australia
Argentina
India
Israel
Mexico
Sweden
Canada
Switzerland
Hungary
Germany
Denmark
Finland
France
Netherlands

location_facility: Rheumatology, The Queen Elizabeth Hospital

location_facility: Kokilaben Dhirubhai Ambani Hospital &Medical Research Inst.

location_facility: Centre de Recherche Musculo-Squelettique

location_facility: Multifield Medical Center of Odesa NMU (University Clinic#1)

location_facility: Centro de Medicina Familiar Mindout Research

location_facility: Regional Clinical Hospital of Zaporizhzhia

location_facility: Instituto de Asist Reumatologica Integral

location_facility: Clínica Enfermedades Crónicas y Procedimientos Especiales SC

location_facility: Reumatologiska Kliniken Karolinska Universitetssjukhuset Solna

location_facility: Organizacion Medica de Investigacion - OMI

location_facility: Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

location_facility: Aalborg Universitetshospital - Psykiatrien

location_facility: National Scientific Center "Strazhesko institute of cardio"

location_facility: Complexo Hospitalario Universitario A Coruña, CHUAC

location_facility: Centre hospitalier universitaire Lapeyronie

location_facility: Government Medical College & Sir Sayajirao General Hospital

location_facility: Municipal Institution of Ternopil Regional Council

location_facility: Klinikum der Johann Wolfgang Goethe-Universität Frankfurt

location_facility: Reumatologiska Kliniken Skånes universitetssjukhus Malmö

location_facility: Centre Hospitalier de Vendee Les Oudairies

location_facility: Centro Investigacion de Tratam Innovadores de Sinaloa SC

location_facility: Twoja Przychodnia-Centrum Medyczne Nowa Sol

location_facility: Byramjee Jeejeebhoy Medical College & Civil Hospital

location_facility: Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan

location_facility: Krishna Institute of Medical Sciences Ltd.

location_facility: Fondazione Universitaria degli Studi G D'Annunzio

location_facility: Hospital Clinico Universitario de Santiago

location_facility: Ruby Hall Clinic and Grant Medical Foundation

location_facility: Suite 509 Umhlanga Netcare Medical Centre

location_facility: Zentrum für klinische Studien Dr. Ursula Hanusch GmbH

location_facility: Regional Clinical Hospital Center for Emergency medical care

location_facility: Ospedale Policlinico Giambattista Rossi, Borgo Roma

summary: The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.


acronym: CheckMate 648

title: A Randomized Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin in Subjects With Unresectable Advanced, Recurrent or Metastatic Previously Untreated Esophageal Squamous Cell Carcinoma

ReferenceCitation: Kato K, Doki Y, Ogata T, Motoyama S, Kawakami H, Ueno M, Kojima T, Shirakawa Y, Okada M, Ishihara R, Kubota Y, Amaya-Chanaga C, Chen T, Matsumura Y, Kitagawa Y. First-line nivolumab plus ipilimumab or chemotherapy versus chemotherapy alone in advanced esophageal squamous cell carcinoma: a Japanese subgroup analysis of open-label, phase 3 trial (CheckMate 648/ONO-4538-50). Esophagus. 2022 Nov 19. doi: 10.1007/s10388-022-00970-1. [Epub ahead of print]

ReferenceCitation: Doki Y, Ajani JA, Kato K, Xu J, Wyrwicz L, Motoyama S, Ogata T, Kawakami H, Hsu CH, Adenis A, El Hajbi F, Di Bartolomeo M, Braghiroli MI, Holtved E, Ostoich SA, Kim HR, Ueno M, Mansoor W, Yang WC, Liu T, Bridgewater J, Makino T, Xynos I, Liu X, Lei M, Kondo K, Patel A, Gricar J, Chau I, Kitagawa Y; CheckMate 648 Trial Investigators. Nivolumab Combination Therapy in Advanced Esophageal Squamous-Cell Carcinoma. N Engl J Med. 2022 Feb 3;386(5):449-462. doi: 10.1056/NEJMoa2111380.

location_country:
Spain
Italy
United Kingdom
United States
Peru
Romania
Japan
Czechia
Poland
Hong Kong
Portugal
Austria
Australia
Russian Federation
Argentina
Turkey
Mexico
Singapore
Brazil
Canada
China
Denmark
Taiwan
Korea, Republic of
France
Chile
Colombia

location_facility: Baptist Health Medical Group Oncology LLC

location_facility: II Klinika Chirurgii Ogolnej, Gastroenterologicznej i Nowotworow Ukladu Pokarmowego

location_facility: Fundacao Pio Xii Hosp Cancer De Barretos

location_facility: Landeskrankenhaus-Universitaetsklinik fuer Innere Medizin III

location_facility: Hospital De Base De Sao Jose Do Rio Preto

location_facility: Oncology & Hematology Associates Of Southwest Virginia, Inc.

location_facility: University Of Miami Sylvester Comprehensive Cancer Center

location_facility: Interni hematologicka a onkologicka klinika

location_facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia

location_facility: The University Of Texas MD Anderson Cancer Center

location_facility: Hospital Nacional Daniel Alcides Carrion

summary: The main purpose of this study is to compare how long subjects with esophageal cancer live overall or live without disease progression after receiving nivolumab and ipilimumab or nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin


title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of CNP520 in Participants at Risk for the Onset of Clinical Symptoms of Alzheimer's Disease (AD).

lead_sponsor: Novartis Pharmaceuticals

location_country:
Spain
Italy
United Kingdom
United States
South Africa
Belgium
Iceland
Japan
Portugal
Australia
Argentina
Puerto Rico
Israel
Mexico
Singapore
Canada
Switzerland
China
Germany
Taiwan
Finland
Korea, Republic of
France
Chile
Netherlands

location_facility: Inspira Clinical Research, Ave Hostos 405

location_facility: Hattiesburg Clinic, 415 South 28th Avenue

location_facility: Syrentis Clinical Research, 1401 N Tustin Ave, Suite 130

location_facility: Advanced Clinical Research, 2950 E Magic View Dr, Suite 182

location_facility: NYU Langone Medical Center, 145 East 32nd Street, 2nd Floor, Room 226

location_facility: Yale University, One Church Street, Suite 600

location_facility: Alexian Brothers Neuroscience, 800 Biesterfield Rd, Neuroscience Institute Brock

location_facility: Albuquerque Neuroscience, 101 Hospital Loop ne, 209 209

location_facility: Mountain Neurological Research, 350 Market Street, Suite 316

location_facility: Miami-Dade Medical Research, 8955 SW 87 CT, Suite 112

location_facility: Summit Research Network, 2701 NW Vaughn St, Suite 350

location_facility: Abington Neurological Associate Ltd., 2325 Maryland Road, Suite 100

location_facility: Roper Hospital, 316 Calhoun Street 5th Floor

location_facility: Brain Matters Research, Inc., 800 NW 17th Avenue

location_facility: Banner Sun Health Research Institute, 10515 West Santa Fe Drive, Building B

location_facility: Irvine Center for Clinical Res, 2515 McCabe Way

location_facility: New Horizon Research Center, 11880 SW 40 St., Suite 405

location_facility: Alzheimer's Research and Treatment Center, 5065 State Road 7, Suite 102

location_facility: Meridien Research, 2300 Maitland center, Pkwy Ste 230

location_facility: Tulsa Clinical Research LLC, 1705 E 19th ST., STE 406/408

location_facility: Denver Neurological Clinic, 950 E Harvard Ave

location_facility: Compass Research, LLC,100 West Gore Street, Suite 202

location_facility: Roskamp Institute, Inc., 2040 Whitfield Avenue

location_facility: QUEST Research Institute, 28595 Orchard Lake Road, Suite 301

location_facility: Banner Alzheimer's Institute, 901 East Willetta Street

location_facility: Hawaii Pacific Neuroscience, 2230 Liliha st 104

location_facility: Torrance Clinical Research Institute, 25043 Narbonne Avenue

location_facility: Colorado Springs Neurological, 2312 North Nevada Avenue, Suite 100

location_facility: Toronto Memory Program, 1 Valleybrook Drive Suite 400

location_facility: ANI Neurology, PLLC dba Alzhe, 7809 Sardis Road

location_facility: Infinity Clinical Research LLC, 4925 Sheridan Street, Suite 200

location_facility: Rhode Island Hospital and Memory Research Institute, 1018 Waterman Ave

location_facility: ATP Clinical Research Inc, 3151 Airway Avenue T 3

summary: The purpose of this study is to determine the effects of CNP520 on cognition, global clinical status, and underlying AD pathology, as well as the safety of CNP520, in people at risk for the onset of clinical symptoms of AD based on their age, APOE genotype and elevated amyloid.


acronym: Dose-ranging study of nemolizumab in atopic dermatitis

title: Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Dose-ranging Study to Assess the Efficacy and Safety of Nemolizumab in Moderate-to-severe Atopic Dermatitis Subjects With Severe Pruritus Receiving Topical Corticosteroids (TCS)

lead_sponsor: Galderma R&D

ReferenceCitation: Silverberg JI, Pinter A, Pulka G, Poulin Y, Bouaziz JD, Wollenberg A, Murrell DF, Alexis A, Lindsey L, Ahmad F, Piketty C, Clucas A. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol. 2020 Jan;145(1):173-182. doi: 10.1016/j.jaci.2019.08.013. Epub 2019 Aug 23.

location_country:
Poland
Australia
Canada
United States
France
Germany

location_facility:
Galderma Investigational Site
Galderma Investigational site

summary: Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.


acronym: Aspire II

title: A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Subjects Assessed to be at Imminent Risk for Suicide

ReferenceCitation: Rozjabek H, Li N, Hartmann H, Fu DJ, Canuso C, Jamieson C. Assessing the meaningful change threshold of Quality of Life in Depression Scale using data from two phase 3 studies of esketamine nasal spray. J Patient Rep Outcomes. 2022 Jul 10;6(1):74. doi: 10.1186/s41687-022-00453-y.

ReferenceCitation: Dean RL, Hurducas C, Hawton K, Spyridi S, Cowen PJ, Hollingsworth S, Marquardt T, Barnes A, Smith R, McShane R, Turner EH, Cipriani A. Ketamine and other glutamate receptor modulators for depression in adults with unipolar major depressive disorder. Cochrane Database Syst Rev. 2021 Sep 12;9:CD011612. doi: 10.1002/14651858.CD011612.pub3. Review.

ReferenceCitation: Ionescu DF, Fu DJ, Qiu X, Lane R, Lim P, Kasper S, Hough D, Drevets WC, Manji H, Canuso CM. Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients With Major Depressive Disorder Who Have Active Suicide Ideation With Intent: Results of a Phase 3, Double-Blind, Randomized Study (ASPIRE II). Int J Neuropsychopharmacol. 2021 Jan 20;24(1):22-31. doi: 10.1093/ijnp/pyaa068.

location_country:
Poland
Brazil
Spain
Austria
Argentina
Canada
Lithuania
United States
France
Turkey
Belgium
Czechia

location_facility: Clinica Privada de Salud Mental Santa Teresa de Ávila

location_facility: SPZOZ CSK UM w Lodzi Klinika Zaburzen Afektywnych i Psychotycznych

location_facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos

location_facility: Bursa Sevket Yilmaz Research and Training Hospital

location_facility: University of Cincinnati, Dept of Psychiatry & Behavioral Neuroscience

location_facility: Hospital Das Clinicas Da Universidade Federal De Minas Gerais

location_facility: Institut universitaire en sante mentale de Montreal

location_facility: University of Conneticut School of Medicine

location_facility: University of California San Diego/Psychiatry

location_facility: Klinika Psychiatryczna WUM Mazowieckie Specjalistyczne Centrum Zdrowia im prof Jana Mazurkiewicza

location_facility: Hospital Universitario Professor Edgar Santos

location_facility: Hospital of Lithuanian University of Health Sciences Kaunas Clinics

location_facility: Szpital Specjalistyczny im. H. Klimontowicza, Oddzial Psychiatryczny

summary: The purpose of this study is to evaluate the efficacy of intranasal esketamine 84 milligram (mg) compared with intranasal placebo in addition to comprehensive standard of care in reducing the symptoms of Major Depressive Disorder (MDD), including suicidal ideation, in participants who are assessed to be at imminent risk for suicide, as measured by the change from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at 24 hours post first dose.