chufangao/CTO huggingface dataset:
Clinical trial NCT03760250: Imiquimod for Preventing Keloid Recurrence
Official title: Open-label, Single-arm Pilot Study of the Effects of Topical 5% Imiquimod Cream on Preventing Keloid Recurrence After Surgical Keloidectomy
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Investigator decision
Enrollment: 6.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-02-05
Primary completion date: 2019-09-05
Completion date: 2020-09-01
Clinical trial NCT02164734: Surfactant Via Endotracheal Tube vs. Laryngeal Mask Airway (LMA) in Preterm Neonates With Respiratory Distress Syndrome
Official title: Efficacy of Rescue Surfactant Delivery Via Endotracheal Intubation (INSURE Technique) Versus Laryngeal Mask Airway (LMA) for Respiratory Distress Syndrome (RDS) in Preterm Neonates
Sponsor: Albany Medical College (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Slow to impossible recruitment during COVID-19 pandemic
Enrollment: 93.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-06-30
Primary completion date: 2020-05-20
Completion date: 2020-12-31
Baseline population: Intention-to-treat analysis
Limitations and caveats: The trial was terminated before the target enrollment numbers were reached, due to slow recruitment, which became impossible soon after the onset of the COVID-19 pandemic.
Clinical trial NCT04461028: Liposomal Bupivacaine in Shoulder Arthroscopy
Official title: The Effect of Liposomal Bupivacaine on the Quality of Recovery in Patients Undergoing Shoulder Arthroscopy
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: PI departed from the institution and study was closed.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-21
Primary completion date: 2022-06-27
Completion date: 2022-06-27
Plan to share individual participant data: NO
Clinical trial NCT02466243: Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study to Investigate the Safety, Tolerability, and Efficacy of JBT-101 in Subjects With Dermatomyositis
Sponsor: Corbus Pharmaceuticals Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Sponsor terminated open-label extension.
Enrollment: 22.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-06-30
Primary completion date: 2017-08-31
Completion date: 2021-01-29
Baseline population: Numbers reflect all randomized subjects; all subjects were included in the safety, modified intent-to-treat, and per protocol populations
Clinical trial NCT04823845: Plantar Wart Treatment Using Adapalene Gel
Official title: Plantar Wart Treatment Using Adapalene Gel
Sponsor: University of Louisville (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: Study never received IRB approval.
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-05-01
Primary completion date: 2022-12-10
Completion date: 2023-02-10
Plan to share individual participant data: NO
IPD sharing description: IPD will only be obtained/used by the researchers and no individual patient identifiers will be used.
Clinical trial NCT02366143: A Study of Atezolizumab in Combination With Carboplatin Plus (+) Paclitaxel With or Without Bevacizumab Compared With Carboplatin+Paclitaxel+Bevacizumab in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
Official title: A Phase III, Open-Label, Randomized Study of Atezolizumab (MPDL3280A, Anti-PD-L1 Antibody) in Combination With Carboplatin+Paclitaxel With or Without Bevacizumab Compared With Carboplatin + Paclitaxel + Bevacizumab in Chemotherapy-Naïve Patients With Stage IV Non-Squamous Non-Small Cell Lung Cancer
Acronym: IMpower150
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1202.0 (ACTUAL)
Number of arms: 3.0
Start date: 2015-03-31
Primary completion date: 2019-09-13
Completion date: 2020-12-07
Clinical trial NCT03197025: Immunotherapy With E6 T Cell Receptor (TCR) T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions
Official title: A Phase I Study of Immunotherapy With E6 T Cell Receptor T Cells for Vulvar High-Grade Squamous Intraepithelial Lesions
Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The study was closed due to investigator discretion based on the lack of perceived clinical activity observed in the study.
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-01-09
Primary completion date: 2019-05-14
Completion date: 2020-10-16
Baseline population: One participant was enrolled, thus Arm/Group - 2/Arm 2 MTD was not done.
Plan to share individual participant data: NO
Clinical trial NCT01938001: Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma)
Official title: A Phase 3, Double-blind, Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Placebo in Subjects With Relapsed/Refractory Indolent Lymphoma
Acronym: AUGMENT
Sponsor: Celgene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 358.0 (ACTUAL)
Number of arms: 2.0
Start date: 2013-11-21
Primary completion date: 2018-06-22
Completion date: 2022-01-26
Baseline population: The intent to treat (ITT) population was defined as all participants who were randomized into the trial, regardless of whether they received investigational product (IP) or not.
Clinical trial NCT05124561: Study to Evaluate the inHaled Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) On the Protective-Efficacy in Adults (SeiHOPE)
Official title: A Multicenter, Randomized, Double-blind, Parallel-controlled Phase III Clinical Trial on the Efficacy, Safety, and Immunogenicity of Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation (Ad5-nCoV-IH) in Adults Aged 18 Years and Above Who Have Received One Dose of Intramuscular Ad5-nCoV
Sponsor: CanSino Biologics Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: WITHDRAWN 
Why stopped: The trial protocol was not approved by the regulatory authorities.
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-12-15
Primary completion date: 2022-04-15
Completion date: 2022-08-20
Plan to share individual participant data: NO
Clinical trial NCT04397796: Study of the Safety of Therapeutic Tx With Immunomodulatory MSC in Adults With COVID-19 Infection Requiring Mechanical Ventilation
Official title: Phase 1b Randomized, Double-Blind, Placebo-Controlled Study Of The Safety Of Therapeutic Treatment With Immunomodulatory Mesenchymal Stem Cells In Adults With COVID-19 Infection Requiring Mechanical Ventilation
Sponsor: ImmunityBio, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Study halted prematurely and will not resume; participants are no longer being examined or receiving intervention.
Enrollment: 4.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-08-03
Primary completion date: 2020-09-06
Completion date: 2020-09-06
Limitations and caveats: The study is terminated early due to low enrollment. Efficacy of the Investigational Product is not analyzed.~Race was not collected in the CRFs for subjects and therefore is not presented in the data output for these subjects.~Treatment-Emergent Adverse Events Table includes Serious Adverse Events.
Plan to share individual participant data: NO
Clinical trial NCT03911869: An Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-mutant Melanoma Brain Metastasis
Official title: A Phase 2, Open-Label, Randomized, Multicenter Trial of Encorafenib + Binimetinib Evaluating a Standard-dose and a High-dose Regimen in Patients With BRAFV600-Mutant Melanoma Brain Metastasis
Acronym: POLARIS
Sponsor: Pfizer (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Study terminated due to lack of enrollment of the target population. There were no safety, efficacy, or regulatory interaction involved in the decision to stop enrollment.
Enrollment: 13.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-04-30
Primary completion date: 2022-01-27
Completion date: 2022-01-27
Baseline population: The safety set included all participants who received at least 1 dose of any study drug.
Limitations and caveats: Data for pharmacokinetic outcome measure for Phase 2 was not collected and analyzed as sampling was insufficient to support noncompartmental analysis in participants.
Plan to share individual participant data: YES
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.
Clinical trial NCT04129320: Enoblituzumab Plus MGA012 or MGD013 in Squamous Cell Carcinoma of the Head and Neck
Official title: A Phase 2/3 Open-Label Trial to Evaluate Enoblituzumab in Combination With MGA012 or MGD013 in the First-Line Treatment of Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Sponsor: MacroGenics (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: WITHDRAWN 
Why stopped: Change in study design
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-10-31
Primary completion date: 2020-10-31
Completion date: 2022-10-31
Plan to share individual participant data: NO
Clinical trial NCT04406389: Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial)
Official title: InterMediate ProphylACtic Versus Therapeutic Dose Anticoagulation in Critically Ill Patients With COVID-19: A Prospective Randomized Study (The IMPACT Trial)
Acronym: IMPACT
Sponsor: Weill Medical College of Cornell University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Low accrual
Enrollment: 14.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-10-13
Primary completion date: 2021-04-17
Completion date: 2022-04-21
Limitations and caveats: The statistical analysis plan (and associated statistical power) was based on an expected sample size of 186 participants. As only 14 participants enrolled, this reduced sample size is not sufficient for the statistical analysis plan as written, and, therefore, only descriptive statistics are presented for the study.
Plan to share individual participant data: NO
Clinical trial NCT04328012: COVID MED Trial - Comparison Of Therapeutics for Hospitalized Patients Infected With COVID-19
Official title: Comparison Of Therapeutics for Hospitalized Patients Infected With SARS-CoV-2 In a Pragmatic aDaptive randoMizED Clinical Trial During the COVID-19 Pandemic (COVID MED Trial)
Acronym: COVIDMED
Sponsor: Bassett Healthcare (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: difficult enrollment
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-04-06
Primary completion date: 2021-07-01
Completion date: 2021-12-01
Plan to share individual participant data: NO
Clinical trial NCT03928314: Study of ORIC-101 in Combination With Anticancer Therapy
Official title: An Open-label Phase 1b Study of ORIC-101 in Combination With Anticancer Therapy in Patients With Advanced or Metastatic Solid Tumors
Sponsor: ORIC Pharmaceuticals (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: IND Withdrawn
Enrollment: 83.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-05-02
Primary completion date: 2022-09-22
Completion date: 2023-12-04
Clinical trial NCT03221257: Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate
Official title: Scleroderma Lung Study III (SLS III): Combining the Anti-fibrotic Effects of Pirfenidone (PFD) With Mycophenolate (MMF) for Treating Scleroderma-related Interstitial Lung Disease
Acronym: SLSIII
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 51.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-11-28
Primary completion date: 2022-03-23
Completion date: 2022-06-13
Baseline population: Safety population includes all the randomized participants who received at least one dose of study medication.
Limitations and caveats: Only 51 (34%) of our planned recruitment goal of 150 were randomized. During the recruitment period MMF became a standard of care for treatment in early systemic sclerosis (SSc)-ILD, including the treatment of both lung and skin disease, thereby increasing the difficulty in recruiting treatment-naïve patients. Other barriers to recruitment included the Coronavirus Disease 2019 (COVID-19) epidemic and FDA approval of nintedanib as an alternative treatment during the initial phase of the trial.
Plan to share individual participant data: YES
IPD sharing description: A bio-specimen repository will be created in which de-identified blood specimens will be made available to qualified researchers who submit meritorious applications for the access and use of such samples. Requests for specimens and correlative analyses related to other linked and de-identified clinical data will be overseen by the Study Executive and Steering Committees and/or any sub-committees that they may appoint for this process.
IPD time frame: Sharing will be made available after completion of the clinical trial and reporting of the primary outcome.
IPD access criteria: Access criteria will be made available after 01/01/2018 through the study website noted below.
Clinical trial NCT02719392: A Pilot Study Investigating the Efficacy of Minocycline and N-Acetyl Cysteine for Bipolar Depression
Official title: A Pilot Study Investigating the Efficacy of Minocycline and N-Acetyl Cysteine for Bipolar Depression
Sponsor: Massachusetts General Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: SUSPENDED 
Why stopped: Due to limited study staff and the COVID-19 pandemic, enrollment has been paused as staff hours for this project have been reduced and reallocated to other projects.
Enrollment: 40.0 (ESTIMATED)
Number of arms: 4.0
Start date: 2017-08-09
Primary completion date: 2023-06-30
Completion date: 2024-04-30
Plan to share individual participant data: NO
Clinical trial NCT03903718: Evaluation of the Safety and Efficacy of a Monoclonal Antibody to Treat Influenza
Official title: A Phase 1/2a Clinical Study to Evaluate the Efficacy of MEDI8852 in the Treatment of Influenza in Adults Challenged With a Wild-Type Influenza Strain
Sponsor: MedImmune LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Terminated due to delay in site enrollment timelines
Enrollment: 0.0 (ACTUAL)
Number of arms: 6.0
Start date: 2020-04-03
Primary completion date: 2020-10-09
Completion date: 2020-10-09
Clinical trial NCT04968912: A Study of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)
Official title: A Randomized, Placebo-controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Nipocalimab in Adults With Primary Sjogren's Syndrome (pSS)
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 163.0 (ACTUAL)
Number of arms: 3.0
Start date: 2021-09-21
Primary completion date: 2023-10-23
Completion date: 2023-11-30
Plan to share individual participant data: YES
IPD sharing description: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale open Data Access (YODA) Project site at yoda.yale.edu
Clinical trial NCT04878614: Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding
Official title: Comparison of Levothyroxine Formulation in Hypothyroid Patients With Enteral Feeding
Sponsor: University of California, Los Angeles (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Sponsor terminated study low accrual numbers
Enrollment: 3.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-05
Primary completion date: 2022-02-16
Completion date: 2022-02-16
Clinical trial NCT03575065: Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China
Official title: An Open Label, Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China
Sponsor: BeiGene (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 88.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-06-22
Primary completion date: 2020-10-09
Completion date: 2021-04-14
Baseline population: Safety Analysis Set included all participants who received at least 1 dose of pamiparib (BGB-290)
Clinical trial NCT02996760: Influence Instillation Plasma Rich in Growth Factors in Endometrial Cavity Endometrial Development in Assisted Reproduction.
Official title: Influence Instillation Plasma Rich in Growth Factors in Endometrial Cavity
Sponsor: IVI Bilbao (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: difficulty in recruiting
Enrollment: 22.0 (ACTUAL)
Number of arms: 2.0
Start date: 2018-03-14
Primary completion date: 2021-12-31
Completion date: 2021-12-31
Clinical trial NCT04569084: Efficacy and Safety Study of Oral Edaravone Administered in Subjects With ALS
Official title: A Phase 3b, Multicenter, Randomized, Double-Blind Study to Evaluate Efficacy and Safety of Oral Edaravone Administered for a Period of 48 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)
Sponsor: Mitsubishi Tanabe Pharma America Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Futility was met.
Enrollment: 384.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-13
Primary completion date: 2023-09-29
Completion date: 2023-09-29
Plan to share individual participant data: UNDECIDED
Clinical trial NCT02776514: Steroids, Hyaluronic Acid or Platelet Rich Plasma Versus Placebo for the Knee Osteoarthritis
Official title: Intraarticular Injections of Steroids, Hyaluronic Acid or Platelet Rich Plasma Versus Placebo for the Knee Osteoarthritis
Acronym: KIT
Sponsor: Balgrist University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 120.0 (ACTUAL)
Number of arms: 4.0
Start date: 2016-02-29
Primary completion date: 2020-11-30
Completion date: 2020-11-30
Plan to share individual participant data: NO
Clinical trial NCT03837509: INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma
Official title: A Randomized Open-Label Phase 1/2 Study of INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Participants With Relapsed or Refractory Multiple Myeloma
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: This decision follows recruitment difficulties. No safety-related concerns impacted this decision.
Enrollment: 15.0 (ACTUAL)
Number of arms: 3.0
Start date: 2019-09-25
Primary completion date: 2022-04-05
Completion date: 2022-04-05
Limitations and caveats: The study was terminated following a recruitment challenge. There were no safety-related concerns.
Plan to share individual participant data: NO
Clinical trial NCT05813314: Bioequivalence Study to Compare Two Injection Devices for BMN 111 in Healthy Participants
Official title: A Phase 1, Randomized, Open-Label, Sponsor-Open, Two-Sequence, Two-Period Crossover Study to Investigate the Bioequivalence of a Single Subcutaneous Dose of BMN 111 Administered Using Either a Vial and Syringe or Injector Pen in Healthy Adult Participants
Sponsor: BioMarin Pharmaceutical (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: The BMN 111-104 study has terminated as further optimization of the approach to achieve bio equivalence is required. The study termination was not due to any patient safety concerns.
Enrollment: 36.0 (ACTUAL)
Number of arms: 2.0
Start date: 2023-03-15
Primary completion date: 2023-06-14
Completion date: 2023-06-14
Clinical trial NCT03518021: Naloxone Nasal Spray Compared With Naloxone Injection for Opioid Overdoses Outside the Hospital
Official title: NTNU Intranasal Naloxone Trial - a Double Blinded, Double Dummy, Randomized Controlled Trial of Intranasal Naloxone for Pre-hospital Use
Acronym: NINA-1
Sponsor: Norwegian University of Science and Technology (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 286.0 (ACTUAL)
Number of arms: 4.0
Start date: 2018-05-15
Primary completion date: 2020-10-06
Completion date: 2020-10-06
Plan to share individual participant data: YES
IPD sharing description: NTNU has complete ownership and publishing rights of all results, regardless of outcome. The full protocol, Statistical Analysis Plan, information letter for consent and other trial documents will be published open access in the NTNU Open repository. The Clinical Study report and Statistical Analysis Report will also be made openly available, but open versions may be censored to ensure that it will not be possible to identify individual study participants. The datasets analysed during the current study will be made available from NTNU upon reasonable request and a methodological sound proposal based on the consent given by participants.
IPD time frame: Updated regularly, but no later than one year after publication of main results
IPD access criteria: NTNU will require data processor agreements for recipients conform to standards set out in Norwegian Law and the European General Data Protection Regulation. Any shared datasets will have pseudonymisation of personal data. If doubt NTNU will seek advice from Ethics Committee.
Clinical trial NCT03205761: Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer
Official title: A Phase II Clinical Trial to Analyse Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer (COMETA-Breast Study)
Acronym: COMETABreast
Sponsor: Spanish Breast Cancer Research Group (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-10-23
Primary completion date: 2022-12-15
Completion date: 2022-12-15
Plan to share individual participant data: NO
Clinical trial NCT01722331: A Study to Evaluate the Efficacy and Safety of Subcutaneous MK-3222, Followed by an Optional Long-Term Safety Extension Study, in Participants With Moderate-to-Severe Chronic Plaque Psoriasis (MK-3222-010)
Official title: A 64-Week, Phase 3, Randomized, Placebo-Controlled, Parallel Design Study to Evaluate the Efficacy and Safety/Tolerability of Subcutaneous Tildrakizumab (SCH 900222/MK-3222), Followed by an Optional Long-Term Safety Extension Study, in Subjects With Moderate-to-Severe Chronic Plaque Psoriasis (Protocol No. MK-3222-010)
Acronym: reSURFACE 1
Sponsor: Sun Pharmaceutical Industries Limited (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 772.0 (ACTUAL)
Number of arms: 3.0
Start date: 2012-12-06
Primary completion date: 2015-10-28
Completion date: 2021-11-10
Baseline population: Overall Number of Baseline Participants includes randomized participants according to assigned treatment for Part 1 of the study.