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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    150
  • sponsor
    Protagonist Therapeutics, Inc.
Updated on 21 September 2021

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).

Description

The study consists of a 12-week double-blind, placebo-controlled treatment period. Participants will be randomized in a 1:1:1 ratio to PN-943 450 mg BID, PN-943 150 mg BID, or matching placebo BID.

Participants who successfully complete the double-blind period may be eligible for an extended treatment period of 40 weeks duration.

Details
Condition Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe
Treatment Placebo, PN-943
Clinical Study IdentifierNCT04504383
SponsorProtagonist Therapeutics, Inc.
Last Modified on21 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male and female subjects age 18 (or the minimum country specific age of consent if >18) to 75 years
Subject understands the study procedures and agrees to participate in the study by giving written informed consent
Diagnosis of UC supported by appropriate documentation of biopsy results consistent with UC
Moderate to severe active UC
Demonstrated inadequate response, loss of response, or intolerance of at least 1 of oral aminosalicylates (5-ASAs), corticosteroids, immunomodulators, or a biologic (excluding vedolizumab)

Exclusion Criteria

Subject with a current diagnosis of Crohn's disease (CD), indeterminate colitis (IC), microscopic colitis, ischemic colitis, radiation colitis
History of colonic dysplasia other than completely removed low-grade dysplastic lesion
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
Prior treatment with vedolizumab, natalizumab, or any agent targeting the 47 or 1 integrin or planned during the study
Positive stool test for C. difficile
Chronic recurrent or serious infection
Known primary or secondary immunodeficiency
Pregnant or lactating female or considering becoming pregnant during the study or within 30 days after the last dose of study medication
History of any major neurological disorders
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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