At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 121 enrolled
Drug / intervention
PLN-74809 +1 moredrug
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 Randomized, Double-blind, Dose-ranging, Placebo-controlled, Phase 2a Evaluation of the Safety, Tolerability, and Pharmacokinetics of PLN-74809 in Participants With Primary Sclerosing Cholangitis (PSC) and Suspected Liver Fibrosis (INTEGRIS-PSC)
In Brief
A Phase 2 clinical trial evaluating PLN-74809 and Placebo for Primary Sclerosing Cholangitis. Completed, enrolled 121 participants across 60 sites in 9 countries.
Detailed Summary
A Phase 2a, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study to evaluate the safety, tolerability, and PK of PLN-74809 in participants with primary sclerosing cholangitis and suspected liver fibrosis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Sclerosing Cholangitis
CountriesAustralia, Austria, Belgium, Canada, France, Germany, Netherlands, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartJul 2020
Primary CompletionFeb 2024
Study CompletionMar 2024
TodayJul 2026
First PostedJul 21, 2020
Enrollment StartJul 27, 2020
Primary CompletionFeb 26, 2024
Study CompletionMar 18, 2024
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 5.9 years ago
Interventions
PLN-74809drug
PLN-74809
Placebodrug
Placebo