At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 235 enrolled
Drug / intervention
Simtuzumab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase Like 2 (LOXL2) in Subjects With Primary Sclerosing Cholangitis (PSC)
In Brief
A Phase 2 clinical trial evaluating Simtuzumab and Placebo for Primary Sclerosing Cholangitis (PSC). Completed, enrolled 235 participants across 75 sites in 10 countries.
Detailed Summary
The purpose of this study is to evaluate whether simtuzumab (GS-6624) is effective at preventing the progression of liver fibrosis in adults with primary sclerosing cholangitis (PSC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Sclerosing Cholangitis (PSC)
CountriesBelgium, Canada, Denmark, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartMar 2013
Primary CompletionAug 2016
Study CompletionAug 2016
TodayJul 2026
First PostedAug 27, 2012
Enrollment StartMar 4, 2013
Primary CompletionAug 8, 2016
Study CompletionAug 24, 2016
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 13.8 years ago
Interventions
Simtuzumabbiological
Subcutaneous injections weekly for a total of 96 injections
Placebobiological
Subcutaneous injections weekly for a total of 96 injections