chufangao/CTO huggingface dataset:
Clinical trial NCT02458313: Nicotinic Agonist Effects on BMI and Neuronal Response
Official title: Nicotinic Agonist Effects on BMI and Neuronal Response in Overweight/Obese Adults
Sponsor: University of Colorado, Denver (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 61.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-04-14
Primary completion date: 2021-12-13
Completion date: 2021-12-13
Plan to share individual participant data: NO
Clinical trial NCT02798627: Trial Of NS2359 For The Treatment of Cocaine Dependence
Official title: A Phase II, Double-Blind, Placebo-Controlled, Trial Of NS2359 For The Treatment of Cocaine Dependence
Sponsor: University of Pennsylvania (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 55.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-05-31
Primary completion date: 2020-03-31
Completion date: 2020-10-31
Limitations and caveats: Small numbers of individuals analyzed. Some noncompliance per plasma NS2359 levels at mid and end treatment.
Plan to share individual participant data: NO
Clinical trial NCT05082116: Efficacy and Safety of Turoctocog Alfa Pegol (N8-GP) for Prophylaxis and Treatment of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A (pathfinder10)
Official title: A Multi-centre, Open-label Trial Evaluating Efficacy, Safety and Pharmacokinetics of Turoctocog Alfa Pegol (N8-GP) When Used for Treatment and Prophylaxis of Bleeding Episodes in Previously Treated Chinese Patients With Haemophilia A
Acronym: Pathfinder10
Sponsor: Novo Nordisk A/S (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 36.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-27
Primary completion date: 2022-12-28
Completion date: 2022-12-28
Baseline population: Results were based on the full analysis set (FAS) which included all participants exposed to N8-GP in this trial.
Plan to share individual participant data: YES
IPD sharing description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Clinical trial NCT01942837: Study of Enzalutamide in Patients With Castration-resistant Prostate Cancer
Official title: Phase II Trial of Enzalutamide for Castrate-resistant Prostate Cancer (CRPC) With Correlative Assessment of Androgen Receptor (AR) Signaling and Whole-exome and Transcriptome Sequencing
Sponsor: Dana-Farber Cancer Institute (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: COMPLETED 
Enrollment: 67.0 (ACTUAL)
Number of arms: 1.0
Start date: 2013-09-13
Primary completion date: 2021-12-31
Completion date: 2022-09-30
Baseline population: Patients who received ≥1 dose of enzalutamide. Two patients didn't initiate the treatment.
Plan to share individual participant data: NO
Clinical trial NCT03149679: The p53 Colorectal Cancer Trial
Official title: Treatment of Patients With Metastatic Colorectal Cancer Harboring TP53 Mutations With Dose-dense Cyclophosphamide - the p53 Colorectal Cancer Trial
Sponsor: Haukeland University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: The study was discontinued after the first pre-planned interim analysis due to insufficient response rates.
Enrollment: 12.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-05-09
Primary completion date: 2020-08-07
Completion date: 2020-08-07
Plan to share individual participant data: NO
Clinical trial NCT04720664: Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
Official title: OASIS: Phase II Trial of OrAl SM-88 in Patients With Metastatic Hormone Receptor-posItive HER2-negative (HR+/HER2-) breaSt Cancer
Acronym: OASIS
Sponsor: Georgetown University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: Lack of efficacy
Enrollment: 11.0 (ACTUAL)
Number of arms: 1.0
Start date: 2021-09-22
Primary completion date: 2023-02-10
Completion date: 2023-02-10
Plan to share individual participant data: NO
Clinical trial NCT02856568: Ricolinostat, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Unresectable or Metastatic Cholangiocarcinoma
Official title: A Phase Ib, Open-Label, Dose- Escalation Trial of ACY-1215 in Combination With Gemcitabine and Cisplatin in Patients With Unresectable or Metastatic Cholangiocarcinoma
Sponsor: Mayo Clinic (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: WITHDRAWN 
Why stopped: Site dropped study
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2017-05-01
Primary completion date: 2021-10-31
Completion date: 2021-10-31
Clinical trial NCT02917122: The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease
Official title: The Therapeutic Effect of Transcranial Direct Current Stimulation on Depression in Parkinson's Disease
Acronym: Parkinson's
Sponsor: National Cheng-Kung University Hospital (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Funding is insufficient.
Enrollment: 15.0 (ACTUAL)
Number of arms: 2.0
Start date: 2015-08-31
Primary completion date: 2021-08-31
Completion date: 2021-08-31
Plan to share individual participant data: NO
Clinical trial NCT02066181: Sorafenib Tosylate in Treating Patients With Desmoid Tumors or Aggressive Fibromatosis
Official title: A Phase III, Double Blind, Randomized, Placebo-Controlled Trial of Sorafenib in Desmoid Tumors or Aggressive Fibromatosis (DT/DF)
Sponsor: National Cancer Institute (NCI) (NIH)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 87.0 (ACTUAL)
Number of arms: 2.0
Start date: 2014-03-21
Primary completion date: 2019-07-03
Completion date: 2022-12-01
Clinical trial NCT03771664: A Study to Evaluate the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Participants With Comorbid Major Depressive Disorder (MDD) and Insomnia
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Safety, Tolerability, and Efficacy of SAGE-217 Compared to Placebo in Adult Subjects With Comorbid Major Depressive Disorder and Insomnia
Sponsor: Biogen (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: internal company decision
Enrollment: 87.0 (ACTUAL)
Number of arms: 2.0
Start date: 2019-02-04
Primary completion date: 2019-12-20
Completion date: 2020-01-17
Baseline population: Safety set included all participants who received at least 1 dose of double-blind study drug.
Limitations and caveats: The study was terminated early due to sponsor's decision and there were no safety concerns.
Plan to share individual participant data: YES
IPD sharing description: In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
Clinical trial NCT04983446: In-patient COVID-19 Study of Intranasal Foralumab
Official title: A Phase 2 Proof-of-concept Study to Evaluate the Safety, Tolerability, and Efficacy of Intranasal Foralumab in Hospitalized Subjects With Severe COVID-19 and Pulmonary Inflammation
Sponsor: Tiziana Life Sciences LTD (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Withdrawn due to business reasons
Enrollment: 0.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-04-30
Primary completion date: 2022-10-30
Completion date: 2022-12-30
Plan to share individual participant data: NO
Clinical trial NCT03112603: A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)
Official title: A Phase III Randomized Open-label Multi-center Study of Ruxolitinib vs. Best Available Therapy in Patients With Corticosteroid-refractory Chronic Graft vs Host Disease After Allogeneic Stem Cell Transplantation (REACH3)
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 330.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-06-29
Primary completion date: 2020-05-08
Completion date: 2022-12-15
Plan to share individual participant data: NO
Clinical trial NCT03085095: A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer
Official title: HERO: A Multinational Phase 3 Randomized, Open-label, Parallel Group Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer
Acronym: HERO
Sponsor: Myovant Sciences GmbH (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1134.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-04-18
Primary completion date: 2019-10-25
Completion date: 2021-11-26
Baseline population: All randomized participants who received at least 1 dose of study drug in the primary analysis part of the study.
Plan to share individual participant data: NO
Clinical trial NCT04058964: Pembrolizumab and PEGPH20 in Treating Patients With Metastatic Pancreatic Cancer
Official title: A Pilot Study to Assess the Efficacy and Safety Effects of Pembrolizumab and PEGPH20 (Pegvorhyaluronidase Alfa) in Patients With Metastatic Pancreatic Cancer
Sponsor: M.D. Anderson Cancer Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: WITHDRAWN 
Why stopped: Study withdrawn by supporter
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2020-02-01
Primary completion date: 2022-10-31
Completion date: 2022-10-31
Clinical trial NCT03536208: Biological Effect of Warfarin on Pancreatic Cancer
Official title: Biological Effect of Warfarin on Pancreatic Cancer
Sponsor: University of Texas Southwestern Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: EARLY_PHASE1
Status: WITHDRAWN 
Why stopped: no accrual for over 12 months
Enrollment: 0.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-05-15
Primary completion date: 2021-06-30
Completion date: 2022-06-30
Clinical trial NCT02989597: Intraoperative Methadone Administration for Improved Pain Control in Spinal Fusion Patients
Official title: Single-dose Intraoperative Methadone for Early Ambulation and Sustained Pain Control in Spinal Fusion Surgery Patients
Acronym: MAPS
Sponsor: Montefiore Medical Center (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Due to personnel loss and logistical issues the study was unable to be completed as planned.
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-07-29
Primary completion date: 2020-11-10
Completion date: 2020-11-10
Clinical trial NCT04885907: Third Dose of Moderna COVID-19 Vaccine in Transplant Recipients
Official title: A Randomised, Blinded, Controlled Trial of a Third Dose of Moderna COVID-19 Vaccine Versus Placebo in Solid Organ Transplant Recipients
Sponsor: University Health Network, Toronto (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 120.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-05-25
Primary completion date: 2021-07-30
Completion date: 2021-08-30
Plan to share individual participant data: NO
Clinical trial NCT03822117: Efficacy and Safety of Pemigatinib in Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
Official title: A Phase 2, Open-Label, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib in Participants With Previously Treated Locally Advanced/Metastatic or Surgically Unresectable Solid Tumor Malignancies Harboring Activating FGFR Mutations or Translocations (FIGHT-207)
Sponsor: Incyte Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2
Status: TERMINATED 
Why stopped: A business decision was made to to discontinue further enrollment. There were no safety concerns that contributed to this decision.
Enrollment: 111.0 (ACTUAL)
Number of arms: 1.0
Start date: 2019-10-17
Primary completion date: 2022-03-29
Completion date: 2022-03-29
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 NCT02668653: Quizartinib With Standard of Care Chemotherapy and as Continuation Therapy in Patients With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (AML)
Official title: A Phase 3, Double-Blind, Placebo-controlled Study of Quizartinib Administered in Combination With Induction and Consolidation Chemotherapy, and Administered as Continuation Therapy in Subjects 18 to 75 Years Old With Newly Diagnosed FLT3-ITD (+) Acute Myeloid Leukemia (QuANTUM First)
Acronym: QuANTUM-First
Sponsor: Daiichi Sankyo (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 539.0 (ACTUAL)
Number of arms: 2.0
Start date: 2016-09-01
Primary completion date: 2021-08-13
Completion date: 2023-06-16
Baseline population: Demographic and baseline characteristics were assessed in the Intent-to-Treat Analysis Set.
Plan to share individual participant data: YES
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/
IPD time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
IPD access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
Clinical trial NCT05338346: A Study of ATG-018 (ATR Inhibitor) Treatment in Patients With Advanced Solid Tumors and Hematological Malignancies
Official title: A Phase I, Open-Label, Multi-Center, Dose Finding Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of ATG-018 (ATR Inhibitor) Treatment in Patients With Advanced Solid Tumors and Hematological Malignancies
Acronym: ATRIUM
Sponsor: Antengene Corporation (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: TERMINATED 
Why stopped: Lack of efficacy of study compound
Enrollment: 22.0 (ACTUAL)
Number of arms: 1.0
Start date: 2022-07-08
Primary completion date: 2024-01-08
Completion date: 2024-01-08
Clinical trial NCT04894266: An Open-Label Study of Apabetalone in Covid Infection
Official title: An Open-Label Study to Assess the Safety and Effect on Clinical Course and Key Biomarkers of Oral Apabetalone in Hospitalized Subjects With Covid-19 Infection in Addition to Standard of Care (SOC)
Sponsor: Resverlogix Corp (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE2/PHASE3
Status: TERMINATED 
Why stopped: Unable to recruit subjects
Enrollment: 1.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-01-14
Primary completion date: 2022-06-22
Completion date: 2022-06-22
Plan to share individual participant data: NO
Clinical trial NCT03738215: Efficacy, Safety and Tolerability of Cariprazine as an Adjunctive Treatment to Antidepressant Therapy (ADT) in Patients With Major Depressive Disorder (MDD) Who Have Had an Inadequate Response to Antidepressants Alone
Official title: A Double-Blind, Placebo-Controlled Study of Cariprazine as an Adjunct to Antidepressants in the Treatment of Patients With Major Depressive Disorder Who Have Had an Inadequate Response to Antidepressants Alone
Sponsor: AbbVie (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 759.0 (ACTUAL)
Number of arms: 3.0
Start date: 2018-11-09
Primary completion date: 2021-09-30
Completion date: 2021-09-30
Baseline population: Safety Population included all participants in the randomized population who took ≥ 1 dose of double-blind investigational product.
Plan to share individual participant data: YES
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.
IPD time frame: For details on when studies are available for sharing, please refer to the link below
IPD access criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
Clinical trial NCT04546672: Sugammadex To IMprove Bowel Function
Official title: An Assessor-blinded, Randomized, Controlled, Single Center, Parallel Design Trial With Patient Masking to Compare Early Postoperative Gastric Emptying Associated With Rocuronium Neuromuscular Reversal With Sugammadex Versus Neostigmine in Adults Undergoing Colon and Rectal Surgery
Acronym: STIM_Bowel
Sponsor: Oregon Health and Science University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: COMPLETED 
Enrollment: 120.0 (ACTUAL)
Number of arms: 2.0
Start date: 2021-03-16
Primary completion date: 2023-06-14
Completion date: 2023-08-13
Plan to share individual participant data: NO
Clinical trial NCT03038100: A Study of Atezolizumab Versus Placebo in Combination With Paclitaxel, Carboplatin, and Bevacizumab in Participants With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official title: A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Acronym: IMagyn050
Sponsor: Hoffmann-La Roche (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: COMPLETED 
Enrollment: 1301.0 (ACTUAL)
Number of arms: 2.0
Start date: 2017-03-08
Primary completion date: 2022-02-08
Completion date: 2022-08-12
Clinical trial NCT04586439: A Study of JNJ-73763989 in Healthy Chinese Adult Participants
Official title: A Randomized, Open-Label, Parallel, Single Dose Study to Investigate Pharmacokinetics, Safety, and Tolerability of JNJ-73763989 in Healthy Chinese Adult Participants
Sponsor: Janssen Research & Development, LLC (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1
Status: COMPLETED 
Enrollment: 18.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-11-24
Primary completion date: 2021-02-18
Completion date: 2021-02-18
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 NCT04476797: Phase I/II Study of SBRT and GC4711 for Centrally Located or Large NSCLC
Official title: GRECO-1: Phase I/II, Randomized, Placebo-Controlled Study of Stereotactic Body Radiation Therapy (SBRT) and GC4711 for Centrally Located or Large, Node-Negative Non-Small Cell Lung Cancer (NSCLC)
Acronym: GRECO-1
Sponsor: Galera Therapeutics, Inc. (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE1/PHASE2
Status: TERMINATED 
Why stopped: Development GC4711 was halted after the lead study in pancreatic cancer was stopped early due to meeting the requirements of a futility analysis
Enrollment: 47.0 (ACTUAL)
Number of arms: 3.0
Start date: 2020-10-18
Primary completion date: 2023-11-28
Completion date: 2023-11-28
Limitations and caveats: Study was terminated early by the Sponsor based on a the results of a futility analysis that was conducted on another program and the Sponsor decided to terminate the develop of GC4711. The last randomized subject did not complete protocol therapy but was followed for safety for a period of 30 days post the last administration of GC4711/Placebo +SBRT.
Plan to share individual participant data: NO
Clinical trial NCT05200403: Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis
Official title: Quantification of Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis on Crisaborole Ointment, 2%
Acronym: PAD
Sponsor: Boston University (OTHER)
Study type: INTERVENTIONAL
Phase: PHASE4
Status: TERMINATED 
Why stopped: Funding was stoppped by grantor.
Enrollment: 118.0 (ACTUAL)
Number of arms: 2.0
Start date: 2022-07-26
Primary completion date: 2024-02-15
Completion date: 2024-02-15
Plan to share individual participant data: NO
Clinical trial NCT04237116: A Study of Secukinumab Treatment in Patients With Plaque Psoriasis and Coexisting Non-alcoholic Fatty Liver Disease (NAFLD)
Official title: A Randomized, Double-blind, Multicenter, 24-week Study of Subcutaneous Secukinumab to Assess Anti-interleukin-17A Treatment in Plaque Psoriasis Patients With Coexisting Non-alcoholic Fatty Liver Disease (pINPOINt)
Acronym: pINPOINt
Sponsor: Novartis (INDUSTRY)
Study type: INTERVENTIONAL
Phase: PHASE3
Status: TERMINATED 
Why stopped: Low enrollment
Enrollment: 10.0 (ACTUAL)
Number of arms: 2.0
Start date: 2020-02-19
Primary completion date: 2021-06-29
Completion date: 2021-07-23
Baseline population: Full Analysis Set
Limitations and caveats: Due to premature termination and limited number of treated patients (7 for secukinumab group and 3 in placebo), the extent of originally planned statistical analyses of efficacy was limited to descriptive summaries (absolute values per visit and changes from baseline; presented as mean and standard deviation) for the PASI score, ALT values, and DLQI scores.
Plan to share individual participant data: YES
IPD sharing description: Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.~This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com