Skip to content

Trial · Interventional

CompletedPhase 2Registry data

PN-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
20202021202220232024
  1. Ph 2

    PN-943 in Adults With Moderate to Severe Active Ulcerative Colitis (UC)

    NCT04504383

    5 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.

  1. 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)
  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
Key Inclusion Criteria: 1. Male and female subjects age 18 (or the minimum country specific age of consent if \>18) to 75 years. 2. Subject understands the study procedures and agrees to participate in the study by giving written informed consent. 3. Diagnosis of UC supported by appropriate documentation of biopsy results consistent with UC. 4. Moderate to severe active UC. 5. Demonstrated inadequate response, loss of response, or intolerance of at least 1 of oral aminosalicylates (5-ASAs), corticosteroids, immunomodulators, or a biologic (excluding vedolizumab). Key Exclusion Criteria: 1. Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC), microscopic colitis, ischemic colitis, radiation colitis. 2. History of colonic dysplasia other than completely removed low-grade dysplastic lesion. 3. History of active bacterial, viral, fungal or mycobacterial infection requiring hospitalization or IV antibiotic/anti-infective treatment within 4 weeks of screening or oral antibiotics/anti-infectives within 2 weeks of screening. 4. Prior treatment with vedolizumab, natalizumab, or any agent targeting the α4β7 or β1 integrin or planned during the study. 5. Positive stool test for C. difficile. 6. Chronic recurrent or serious infection. 7. Known primary or secondary immunodeficiency. 8. Pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication. 9. History of any major neurological disorders.

PepBank is a research reference. Talk to a doctor before you use any peptide.