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

NCT04504383 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2023-04-25

No results posted yet for this study

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).

Conditions

  • Ulcerative Colitis Chronic Moderate
  • Ulcerative Colitis Chronic Severe

Interventions

DRUG

PN-943

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

DRUG

Placebo

Administered by the oral route BID for 12 weeks.

Sponsors & Collaborators

  • Protagonist Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-05
Primary Completion
2023-02-16
Completion
2023-02-16
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Bulgaria
  • Canada
  • Georgia
  • Germany
  • Hungary
  • Italy
  • Poland
  • Russia
  • Serbia
  • South Korea
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04504383 on ClinicalTrials.gov