CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 193 enrolled
Drug / intervention
Seladelpar 10 mg +2 moredrug
Likely dose
Seladelpar 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/NCT04620733
NCT04620733Phase 3Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Nov 9, 2020·Updated Sep 5, 2024

In Brief

A Phase 3 clinical trial evaluating Seladelpar 10 mg, Placebo, and 1 other intervention for Primary Biliary Cholangitis. Completed, enrolled 193 participants across 134 sites in 26 countries.

Detailed Summary

The purposes of this study are to evaluate the treatment effect of seladelpar on composite biochemical improvement in cholestasis markers based on ALP and total bilirubin and to evaluate the safety of seladelpar over 12 months of treatment compared to placebo. The study also checked the effect of treatment on the symptoms of PBC, including pruritus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Biliary Cholangitis
CountriesArgentina, Australia, Austria, Belgium, Canada, Chile, Czechia, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Mexico, New Zealand, Poland, Romania, Russia, South Korea, Spain, Switzerland, Turkey (Türkiye), Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedNov 9, 2020
Enrollment StartApr 21, 2021
Primary CompletionAug 11, 2023
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.6 years ago

Interventions

Seladelpar 10 mgdrug

Seladelpar 10 mg one capsule daily for double-blind period, for a duration of up to 12 months

Placebodrug

One capsule daily for double-blind period, for a duration of up to 12 months

Seladelpar 5 mgdrug

If down-titration needed, one capsule daily for double-blind period, for a duration of up to 12 months