NCT04504383|CompletedPhase 2DMCFDA Drug

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

A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study to Evaluate the Safety and Efficacy of Oral PN-943 in Subjects With Moderate to Severe Active Ulcerative Colitis

Protagonist Therapeutics, Inc.ClinicalTrials.gov

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1 other identifier

PN-943-03

Study Type

interventional

Target

169

Locations

13 countries

Sites

122

Timeline

RegisteredAug 2020

StartedAug 2020

CompletionFeb 2023

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).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

169

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Aug 2020

Geographic Reach

13 countries

122 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.5 years study duration

First Submitted

Initial submission to the registry

August 5, 2020

Completed

Same day until next milestone

Study Start

First participant enrolled

August 5, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2023

Completed

Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

2.5 years

First QC Date

August 5, 2020

Last Update Submit

April 24, 2023

Conditions

Ulcerative Colitis Chronic Moderate Ulcerative Colitis Chronic Severe

Keywords

Inflammatory Bowel Disease (IBD)

Outcome Measures

Primary Outcomes (1)

Proportion of subjects achieving clinical remission at Week 12 compared to placebo.
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)
Week 12

Secondary Outcomes (1)

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

Other Outcomes (1)

Proportion of subjects achieving clinical remission at Week 52.
Week 52

Study Arms (3)

PN-943 450 mg BID

EXPERIMENTAL

Oral administration of PN-943 450 mg BID

Drug: PN-943

PN-943 150 mg BID

EXPERIMENTAL

Oral administration of PN-943 150 mg BID

Drug: PN-943

Placebo BID

PLACEBO COMPARATOR

Oral administration of matching placebo

Drug: Placebo

Interventions

PN-943DRUG

Administered by the oral route BID for the duration of the study.

PN-943 150 mg BIDPN-943 450 mg BID

PlaceboDRUG

Administered by the oral route BID for 12 weeks.

Placebo BID

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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).

You may not qualify if:

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 α4β7 or β1 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.

Contact the study team to confirm eligibility.