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NCT04504383 · ClinicalTrials.gov registry record · Phase 2
PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)
A Phase 2 study, sponsored by Protagonist Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 169
- Enrollment target
NCT04504383: Completed Phase 2 study, sponsored by Protagonist Therapeutics.
NCT04504383 is a Phase 2 study that has completed, run by Protagonist Therapeutics. The registered enrollment target is 169 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04504383, a Phase 2 study, has completed, sponsored by Protagonist Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 169 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily \[BID\] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate to severe active Ulcerative Colitis (UC).
Primary Outcome
Clinical remission is determined using the Adapted Mayo score (sum of 3 subscores from the Mayo score): * Stool frequency subscore (SFS) * Rectal bleeding subscore (RBS) * Endoscopic subscore (ESS)
Interventions
- DRUG Placebo
- DRUG PN-943
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2020-08-05 |
| Est. Completion | 2023-02-16 |
| Phase | Phase 2 |
What the finished NCT04504383 record still lists
NCT04504383 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04504383 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04504383 about?
NCT04504383 is a clinical study titled "PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)". The purpose of the study is to evaluate the safety, tolerability, and clinical efficacy of PN-943 450 mg twice daily \[BID\] and PN-943 150 mg BID, compared with placebo BID, in subjects with moderate to severe active Ulcerative Colitis (UC).
What is the current status of trial NCT04504383?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2020-08-05. Estimated completion is 2023-02-16.
What interventions are being tested in trial NCT04504383?
The interventions under investigation include: Placebo (DRUG), PN-943 (DRUG).
Who is sponsoring clinical trial NCT04504383?
This trial is sponsored by Protagonist Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04504383's enrollment target sits among peer trials
169 403rd of 2000 higher than 1,598 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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