RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
NCT04620733Phase 3Completed
- Lead sponsor
- Gilead Sciences (Industry)
- Enrollment
- 193 (actual)
- Start date
- 21 Apr 2021
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 11 Aug 2023
- Last update posted
- 5 Sep 2024
Design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Randomized
- Intervention model
- Parallel
- Masking
- Double
- Arms
- 2
Interventions
- Seladelpar 10 mg Drug
- Placebo Drug
- Seladelpar 5 mg Drug
Conditions and primary outcome
- Primary Biliary Cholangitis
Primary outcome
Percentage of Participants With Response Criteria for the Composite Endpoint of ALP <1.67 × Upper Limit of Normal (ULN), ≥15% Reduction in ALP, and Total Bilirubin ≤ 1.0× ULN at Month 12 (Month 12); Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs (First dose date up to last dose plus 30 days (up to 13.4 months)); Percentage of Participants With Shift of ≥ 2 CTCAE Grades From Baseline in Treatment-emergent Laboratory Abnormalities Related to Hematology and Select Liver Biochemistry (First dose date up to last dose (up to 13.4 months))
Posted results on ClinicalTrials.gov
Source: ClinicalTrials.gov results for NCT04620733 (opens in a new tab)· Licence: public-domain
First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25
Primary outcomes with a statistical analysis
Percentage of Participants With Response Criteria for the Composite Endpoint of ALP <1.67 × Upper Limit of Normal (ULN), ≥15% Reduction in ALP, and Total Bilirubin ≤ 1.0× ULN at Month 12
- Time frame
- Month 12
- Measure
- Number
- Unit
- percentage of participants
Placebo vs SeladelparSuperiority
- Estimate
- 41.7Risk Difference (RD)
- 95% CI, two-sided
- 27.7 to 53.4
- p-value
- < 0.0001
- Method
- Cochran-Mantel-Haenszel
Serious adverse events
Time frame: All-cause mortality: Up to 20.6 months; Adverse events: Up to last dose plus 30 days (Up to 13.4 months)
| Group | Affected | At risk |
|---|---|---|
| Placebo | 4 | 65 |
| Seladelpar | 9 | 128 |
Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Results from company and journal sources
No editor-confirmed results are on record for this study.
Publications
2 on PubMedSeladelpar Improved Itch, Itch-Related Sleep Disturbance and Measures of Fatigue in Patients With Primary Biliary Cholangitis and Pruritus in the Phase 3 RESPONSE Trial.
Alimentary pharmacology & therapeutics · 2026 Jul
PubMed 41933275 (opens in a new tab)DOI 10.1111/apt.70630 (opens in a new tab)
A Phase 3 Trial of Seladelpar in Primary Biliary Cholangitis.
The New England journal of medicine · 2024 Feb 29
PubMed 38381664 (opens in a new tab)DOI 10.1056/NEJMoa2312100 (opens in a new tab)
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.
CT-VCA trial quality
About CT-VCALoading CT-VCA scores…
Data integrity
Compare what the registry, company releases, FDA documents and publications say about this study.
Drugs on HealthTrade
Source
- NCT04620733 on ClinicalTrials.gov (opens in a new tab) Licence: public-domain. Read
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.
Nothing on this page is medical or investment advice.