Trial · Interventional
CompletedPhase 2Registry dataPN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)
Overview
- Status
- Completed
- Phase
- Phase 2
- Enrollment
- 169 participants (actual)
- Sponsor
- Protagonist Therapeutics, Inc. · Industry
- Design
- Randomized · Triple masking
- Countries
13 countries
United States, Austria, Bulgaria, Canada, Georgia, Germany, Hungary, Italy, Poland, Russia, Serbia, South Korea, Ukraine
- Start
- 5 Aug 2020
- Primary completion
- 16 Feb 2023
- Completion
- 16 Feb 2023
- First posted
- 7 Aug 2020
- Last update posted
- 25 Apr 2023
- Conditions
- Ulcerative Colitis Chronic Moderate · Ulcerative Colitis Chronic Severe
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)
NCT045043835 Aug 2020 to 16 Feb 2023
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Interventions
- PN-943Drug
- PlaceboDrug
Arms3
Experimental
PN-943 450 mg BID
Oral administration of PN-943 450 mg BID
Experimental
PN-943 150 mg BID
Oral administration of PN-943 150 mg BID
Placebo comparator
Placebo BID
Oral administration of matching placebo
Primary outcomes1
Outcomes the sponsor listed as primary.
Proportion of subjects achieving clinical remission at Week 12 compared to placebo.
Time frame · Week 12
Registry description
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)
Secondary outcomes(1)
Comparison between PN-943 high-dose and low-dose individually to placebo.
Time frame · Week 12
Registry description
1. Proportion of subjects with endoscopic improvement. 2. Proportion of subjects achieving endoscopic remission. 3. Proportion of subjects with histological improvement. 4. Proportion of subjects achieving histological remission. 5. Proportion of subjects with mucosal healing.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years up to 75 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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