Overview

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

Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Protagonist Therapeutics, Inc.
Criteria
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.