chufangao/CTO huggingface dataset:
Clinical trial NCT04256733: Cough Desensitization Therapy for Cough Hypersensitivity Syndrome
Official title: A Pilot Study of Cough Reflex Desensitization for the Treatment of Cough Hypersensitivity Syndrome
Sponsor: University of Montana (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: COMPLETED 
Enrollment: 19.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-01
Primary completion date: 2020-11-30
Completion date: 2021-02-13
Plan to share individual participant data: NO
Clinical trial NCT05213143: The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine
Official title: The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine: An Open-label, Single-arm And Multi-center Study for 16 Weeks
Sponsor: Sumitomo Pharma (Suzhou) Co., Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Company's business decision
Enrollment: 13.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-12-30
Primary completion date: 2022-11-18
Completion date: 2022-11-18
Clinical trial NCT05162365: A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19
Official title: A Safety, Tolerability, and Efficacy Study of IBI314 in Ambulatory Patients With COVID-19
Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The company decision that terminated the further develop of the molecule and had notified FDA about the termination as well.
Enrollment: 248.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-06
Primary completion date: 2022-06-29
Completion date: 2022-11-18
Plan to share individual participant data: NO
Clinical trial NCT02735850: Combination of SABR and L19-IL2 in Patients With Stage IV Lung Cancer (ImmunoSABR)
Official title: A Randomized Phase II Trial of the Combination of SBRT With L19-IL2 in Patients With Limited Metastatic Non-small Cell Lung Cancer (NSCLC)
Acronym: ImmunoSABR
Sponsor: Maastricht Radiation Oncology (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Not yet submitted, unclear timelines
Enrollment: 0.0 (ACTUAL)
Number of arms: 4.0
Start date: 2015-12-31
Primary completion date: 2021-02-28
Completion date: 2021-06-30
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03188666: A Study to Examine the Safety, Tolerability and Effects on Abnormal Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva
Official title: A Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effects on Heterotopic Bone Formation of REGN2477 in Patients With Fibrodysplasia Ossificans Progressiva
Acronym: LUMINA-1
Sponsor: Regeneron Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 44.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-26
Primary completion date: 2019-09-16
Completion date: 2021-09-16
Baseline population: The full analysis set (FAS) included all randomized participants and was based on the treatment allocated.
Clinical trial NCT03212807: Study Of Durvalumab and Lenalidomide In R/R EBV Associated DLBCL Subtypes, Primary CNS And Testicular DLBCL
Official title: Phase II Study Of Durvalumab In Combination With Lenalidomide In Relapsed/Refractory EBV Associated Subtypes Of DLBCL, Primary CNS Lymphoma And Primary Testicular DLBCL - DuRIANS (Durvalumab Revlimid In Aggressive NHL Subtypes)
Acronym: DuRIANS
Sponsor: Singapore General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: FDA Hold for Combination Studies using Imids and PD1/PDL1 Compounds
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-08-31
Primary completion date: 2021-02-28
Completion date: 2023-08-31
Plan to share individual participant data: NO
Clinical trial NCT03386162: SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer
Official title: A Phase II Randomized Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy as Maintenance Therapy in Patients With PIK3CA Mutated Advanced Breast Cancer
Acronym: SAFIR-PI3K
Sponsor: UNICANCER (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study was halted Prematurely for low recruitment.
Enrollment: 31.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-15
Primary completion date: 2022-11-18
Completion date: 2022-11-18
Clinical trial NCT04891718: CIVO Intratumoural Microdosing of Anti-Cancer Therapies in Australia
Official title: A Phase 0 Master Protocol Using the CIVO® Platform to Evaluate Intratumoural Microdoses of Anti-Cancer Therapies in Patients With Solid Tumours
Sponsor: Presage Biosciences (INDUSTRY)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Termination by pharmaceutical sponsor
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-15
Primary completion date: 2022-06-05
Completion date: 2022-06-05
Plan to share individual participant data: NO
Clinical trial NCT03783923: A Study of Deflazacort (Emflaza®) in Participants With Limb-Girdle Muscular Dystrophy 2I (LGMD2I)
Official title: A Multicenter Open-Label Study on the Safety and Efficacy of Deflazacort (Emflaza) in Subjects With Limb-Girdle Muscular Dystrophy 2I (LGMD2I)
Sponsor: PTC Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: The study was terminated early due to low enrollment and missing efficacy assessment data due to missed visits related to COVID-19.
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-31
Primary completion date: 2021-01-01
Completion date: 2021-01-01
Baseline population: Enrolled population included all informed-consented participants who met all inclusion and exclusion criteria.
Limitations and caveats: The study was terminated early due to low enrollment and missing efficacy assessment data due to missed visits related to COVID-19.
Clinical trial NCT05561530: A Study of ALG-125755 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single Doses in Healthy Volunteers, and Single and Multiple Doses in CHB Subjects
Official title: A Phase 1/1b, Double-Blind, Randomized, Placebo-Controlled, First-in-Human Study of Subcutaneously Administered ALG-125755 to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics After Single Ascending Doses in Healthy Volunteers (Part 1) and Subjects With Chronic Hepatitis B (Part 2), and Multiple Doses in Subjects With Chronic Hepatitis B (Part 3)
Sponsor: Aligos Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Single doses demonstrated an acceptable safety profile and antiviral activity at all doses evaluated.
Enrollment: 57.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-10-07
Primary completion date: 2023-06-15
Completion date: 2023-06-15
Clinical trial NCT05783180: LACTYFERRIN™ Forte and ZINC Defense™ and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19
Official title: A Randomized, Double-Blinded, Placebo-Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Sesderma LACTYFERRIN™ Forte and Sesderma ZINC Defense™ (Liposomal Bovine Lactoferrin (LbLf) and Liposomal Zn (LZn)) and Standard of Care (SOC) vs SOC in the Treatment of Non-hospitalized Patients With COVID-19
Sponsor: Keralty Hospital, Miami (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Sponsor decided not to move forward with the trial
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-06-30
Primary completion date: 2023-06-30
Completion date: 2024-11-30
Clinical trial NCT04818346: A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Vitiligo
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study of the Efficacy and Safety of INCB054707 Followed by an Extension Period in Participants With Vitiligo
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 171.0 (ACTUAL)
Number of arms: 4.0
Start date: 2021-05-06
Primary completion date: 2022-05-24
Completion date: 2023-05-24
Plan to share individual participant data: YES
IPD sharing description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a 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.~The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
IPD time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
IPD access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Clinical trial NCT03194867: Isatuximab in Combination With Cemiplimab in Relapsed/Refractory Multiple Myeloma (RRMM) Patients
Official title: A Phase 1/2 Study to Evaluate Safety, Pharmacokinetics and Efficacy of Isatuximab in Combination With Cemiplimab in Patients With Relapsed/Refractory Multiple Myeloma
Sponsor: Sanofi (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: COMPLETED 
Enrollment: 109.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-02-21
Primary completion date: 2023-04-05
Completion date: 2023-04-05
Baseline population: Phase 1:The Safety population: All screened participants who received at least 1 dose or a part of a dose of study treatments (isatuximab or cemiplimab), regardless of the amount of treatment administered. Phase 2: The Randomized population: All participants who gave informed consent, were assigned randomization number by interactive response technology (IRT), regardless of whether they received any study treatment or received a different study treatment from which they were randomized.
Plan to share individual participant data: YES
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
Clinical trial NCT03452917: Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
Official title: Randomized Clinical Trial of Sodium Nitrite for Out of Hospital Cardiac Arrest
Acronym: SNOCAT
Sponsor: University of Washington (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: COMPLETED 
Enrollment: 1502.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-02-08
Primary completion date: 2019-12-31
Completion date: 2020-04-30
Baseline population: 5 patients were excluded since they were incarcerated or were less than 18 years of age. We were not allowed to use their data. There were 1492 patients available for analysis.
Plan to share individual participant data: UNDECIDED
Clinical trial NCT05043649: Camsirubicin + Pegfilgrastim to Determine MTD in ASTS
Official title: A Phase 1b, Open-label, Dose-escalation Clinical Study Evaluating the Safety of Camsirubicin With Prophylactic Pegfilgrastim in the Treatment of Advanced Soft Tissue Sarcomas
Sponsor: Monopar Therapeutics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: lack of timely enrollment
Enrollment: 14.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-22
Primary completion date: 2023-10-31
Completion date: 2024-05-13
Plan to share individual participant data: NO
Clinical trial NCT04917679: Eltrombopag Plus Diacerein vs Eltrombopag in Adult ITP
Official title: Eltrombopag Plus Diacerein vs Eltrombopag in Adult Primary Immune Thrombocytopenia: a Multicenter Randomized Controlled Trial
Sponsor: Qilu Hospital of Shandong University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 102.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-09-01
Primary completion date: 2021-12-01
Completion date: 2022-06-01
Clinical trial NCT02393859: Phase 3 Trial of Blinatumomab vs Standard Chemotherapy in Pediatric Subjects With HIgh-Risk (HR) First Relapse B-precursor Acute Lymphoblastic Leukemia (ALL)
Official title: Phase 3 Trial to Investigate the Efficacy, Safety, and Tolerability of Blinatumomab as Consolidation Therapy Versus Conventional Consolidation Chemotherapy in Pediatric Subjects With HR First Relapse B-precursor ALL
Sponsor: Amgen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 111.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-11-10
Primary completion date: 2019-07-17
Completion date: 2022-11-21
Baseline population: The FAS included all randomized participants analyzed according to their randomized treatment assignment, regardless of the treatment received.
Plan to share individual participant data: YES
IPD sharing description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
IPD time frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
IPD access criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below.
Clinical trial NCT00960544: Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism
Official title: Correlation of Genomic Variation in Enzymes Responsible for Metabolism of Capecitabine With Drug Metabolism Using a Limited Pharmacokinetic Sampling Plan
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Principal Investigator departed from institution
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-01-31
Primary completion date: 2021-01-31
Completion date: 2021-01-31
Clinical trial NCT03433144: The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery
Official title: The Effects of Tranexamic Acid on Blood Loss During Orthognathic Surgery
Acronym: TXA-OMFS
Sponsor: Nova Scotia Health Authority (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: WITHDRAWN 
Why stopped: Lack of funding
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-01
Primary completion date: 2019-02-01
Completion date: 2020-07-06
Plan to share individual participant data: NO
IPD sharing description: The data will be used for internal use only
Clinical trial NCT03071094: A Trial to Evaluate the Safety and Efficacy of the Combination of the Oncolytic Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC)
Official title: A Phase I/IIa Trial to Evaluate the Safety and Efficacy of the Combination of the Oncolytic Immunotherapy Pexa-Vec With the PD-1 Receptor Blocking Antibody Nivolumab in the First-line Treatment of Advanced Hepatocellular Carcinoma (HCC)
Sponsor: Transgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: The decision was taken to stop prematurely the trial due to the failure of Pexa-Vec and nivolumab in their respective pivotal trials (i.e., PHOCUS and CheckMate 459).
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-27
Primary completion date: 2020-09-30
Completion date: 2021-02-03
Baseline population: Phase I and Phase IIa: Participants who received at least one dose of either study drug.
Limitations and caveats: The study was terminated prematurely as per Sponsor's decision based on the failure of Pexa-Vec and nivolumab in their respective pivotal trials in HCC. As a consequence, the enrollment in Phase IIa was not completed.
Plan to share individual participant data: NO
Clinical trial NCT04367168: Colchicine in Patients With Mild and Severe Coronavirus Disease
Official title: Double-blind, Placebo-controlled Clinical Trial of the Use of Colchicine for the Management of Patients With Mild and Severe SARS-Cov2 Infection
Acronym: ColchiVID
Sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The intervention was not effective for the outcomes
Enrollment: 116.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-05-27
Primary completion date: 2021-04-27
Completion date: 2021-08-16
Plan to share individual participant data: YES
IPD sharing description: All IPD that underlie results in a publication
IPD time frame: 6 months after publication of the clinical trial
IPD access criteria: Reviewers of scientific journals and researchers who contact the principal researcher by e-mail
Clinical trial NCT03971617: Clinical Trial to Evaluate the Safety and Tolerability of Hydrogen in Patients With Parkinson's Disease
Official title: A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Tolerability of Molecular Hydrogen in Patients With Parkinson's Disease
Sponsor: Stony Brook University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Insufficient enrollment to answer research question
Enrollment: 2.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-29
Primary completion date: 2021-04-29
Completion date: 2021-04-29
Limitations and caveats: Due to low enrollment in this study, we are not able to report on study outcome measures for participants and are unable to draw conclusions.
Clinical trial NCT02808247: Ph II Nintedanib vs. Ifosfamide in Soft Tissue Sarcoma
Official title: A Phase II Multicenter Study Comparing the Efficacy of the Oral Angiogenesis Inhibitor Nintedanib With the Intravenous Cytotoxic Compound Ifosfamide for Treatment of Patients With Advanced Metastatic Soft Tissue Sarcoma After Failure of Systemic Non-oxazaphosporine-based First Line Chemotherapy for Inoperable Disease ANITA
Acronym: ANITA
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC (NETWORK)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Exceed of pre-specified number of failures in the experimental arm
Enrollment: 80.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-07
Primary completion date: 2020-11-03
Completion date: 2021-04-14
Plan to share individual participant data: NO
Clinical trial NCT03549689: Effect of Reducing Nucleotide Exposure on Bone Health (ReNew)
Official title: Effect of Reducing Nucleotide Exposure on Bone Health (ReNew)
Acronym: ReNew
Sponsor: Stanford University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Withdrawn by drug manufacturer
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-01
Primary completion date: 2021-07-01
Completion date: 2021-07-01
Plan to share individual participant data: UNDECIDED
Clinical trial NCT03196765: Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Adrenoleukodystrophy
Official title: Phase I/II, Open-Label, Dose Escalation Study of the Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Childhood Cerebral Adrenoleukodystrophy (CCALD)
Sponsor: NeuroVia, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: WITHDRAWN 
Why stopped: No funding
Enrollment: 0.0 (ACTUAL)
Start date: 2018-08-31
Primary completion date: 2020-12-01
Completion date: 2020-12-01
Plan to share individual participant data: NO
Clinical trial NCT03892018: The Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
Official title: An Open-label, Crossover Study of the Effect of Food on the Pharmacokinetics of Paclitaxel Administered Orally as Oraxol
Sponsor: Athenex, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: STUDY HALTED DUE TO FINANCIAL CONTRAINTS
Enrollment: 29.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-08-05
Primary completion date: 2023-05-12
Completion date: 2023-05-12
Plan to share individual participant data: NO
Clinical trial NCT02994771: A Phase I Study With Lymfactin® in the Treatment of Patients With Secondary Lymphedema
Official title: A Phase I Open-Label Study to Assess the Safety, Tolerability and Preliminary Efficacy of Lymfactin® (AdAptVEGF-C Adenoviral Vector) in Combination With a Surgical Lymph Node Transfer for the Treatment of Patients With Secondary Lymphedema
Sponsor: Herantis Pharma Plc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of efficacy
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-06-30
Primary completion date: 2019-02-03
Completion date: 2022-04-05
Plan to share individual participant data: NO
Clinical trial NCT02065700: Long-term Follow-up Study of GLPG0634 in Active Rheumatoid Arthritis Participants
Official title: A Multicenter, Open-label, Long-term Follow-up Safety and Efficacy Study of GLPG0634 Treatment in Subjects With Moderately to Severely Active Rheumatoid Arthritis
Acronym: DARWIN3
Sponsor: Galapagos NV (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 739.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-02-25
Primary completion date: 2023-01-19
Completion date: 2023-01-19
Baseline population: The Safety Analysis Set included all participants who enrolled in the extension study and received at least one dose of study drug. As prespecified in the protocol, data was collected and analyzed based on their originating parent study I.e. DARWIN 1 and DARWIN 2.
Plan to share individual participant data: YES
IPD sharing description: Qualified external researchers may request IPD for clinical trials that support an approved indication in the EU and the US for which Galapagos is the Marketing Authorisation / New Drug Application Holder, with a marketing authorisation date on or after January 1, 2021 and for which the summary results have been published on ClinicalTrials.gov (CT.gov) and/or the EU Clinical Trials Register (EU CTR). For clinical trials of newly approved compounds or indications the IPD can be requested at earliest 6 months after the EMA and FDA approval. The study last patient last visit (LPLV) must have occurred at least 18 months prior to the request.