A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
← catalyst calendarNCT05627362 · readout in 1,860 d
Sponsored by Ipsen (industry) · IPN.PA — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
68actual
Sites
62
Countries
Canada, Germany, Italy +4
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-12-29 | actual | When the study began enrolling |
| Primary completion | 2031-09-23 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2031-09-23 | estimated | The whole study's end, after follow-up |
| First posted | 2022-11-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Primary Sclerosing Cholangitis
Interventions
- Drug: Elafibranor 80 mg — also filed as GFT505
- Drug: Elafibranor 120 mg — also filed as GFT505
- Drug: Placebo Matched to Elafibranor 80 mg
- Drug: Placebo Matched to Elafibranor 120 mg
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
measured Double Blind Period: Baseline up to week 12, Initial Open Label Extension (OLE) Period: Baseline up to week 100, Open-Label Extension Long-Term (OLE-LT) Period Beyond OLE Week 96: OLE-LT baseline up to OLE-LT Week 260
Percentage of Participants With Clinically Significant Changes in Physical Examination Findings
measured Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
Percentage of Participants With Clinically Significant changes in Laboratory Parameters (blood chemistry, hematology and coagulation)
measured Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
Percentage of Participants With Clinically Significant Changes in Vital Signs
measured Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
Percentage of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Readings
measured Double Blind Period: Baseline up to week 12, Initial OLE Period: Baseline up to week 100
Publications
- PMID 40350321 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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