CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 265 enrolled
Drug / intervention
seladelpar 5-10 mg +2 moredrug
Likely dose
seladelpar 5-10 mgfrom 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.

Search/NCT03602560
NCT03602560Phase 3Completed
CompareCT.gov

A 52-week, Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Safety and Efficacy of Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

Gilead Sciences·interventional·Posted Jul 27, 2018·Updated Aug 2, 2022

In Brief

A Phase 3 clinical trial evaluating seladelpar 5-10 mg, seladelpar 10 mg, and 1 other intervention for Primary Biliary Cholangitis. Completed, enrolled 265 participants across 156 sites in 23 countries.

Detailed Summary

A 52-week, placebo-controlled, randomized, Phase 3 study to evaluate the safety and efficacy of seladelpar in subjects with primary biliary cholangitis (PBC) and an inadequate response to or intolerance to ursodeoxycholic acid (UDCA) The participants might enter the ongoing open-label safety study (NCT03301506) following this double-blind study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Biliary Cholangitis
CountriesArgentina, Australia, Austria, Belgium, Canada, Chile, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, South Korea, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJul 27, 2018
Enrollment StartOct 1, 2018
Primary CompletionFeb 16, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 7.9 years ago

Interventions

seladelpar 5-10 mgdrug

Seladelpar 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects will continue the seladelpar dose (5 or 10 mg) received during the double-blinded study

seladelpar 10 mgdrug

Seladelpar 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label safety study. Subjects will continue the seladelpar dose (10 mg) received during the double-blinded study

Placebodrug

One capsule daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects on placebo will be re-randomized to initiate seladelpar at 5 or 10 mg once daily