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

Phase 2

Completed

• Conditions: Ulcerative Colitis Chronic Moderate; Ulcerative Colitis Chronic Severe
• Interventions: Drug: PN-943; Drug: Placebo

• Registration Number: NCT04504383
• Lead Sponsor: Protagonist Therapeutics, Inc.

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2020-08-05
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-07
• Primary Completion: 2023-02-16
• Study Completion: 2023-02-16
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-24
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PN-943 450 mg BID	PN-943	Oral administration of PN-943 450 mg BID
PN-943 150 mg BID	PN-943	Oral administration of PN-943 150 mg BID
Placebo BID	Placebo	Oral administration of matching placebo

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving clinical remission at Week 12 compared to placebo.	Week 12	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 Outcome Measures

Name	Time	Method
Comparison between PN-943 high-dose and low-dose individually to placebo.	Week 12	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.

Trial Locations

Locations (2)

Protagonist Investigational site; 🇰🇷 Seoul, Korea, Republic of

Protagonist Investigational Site; 🇺🇦 Zhytomyr, Ukraine