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Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis

NCT02895100 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-08-21

Study results available
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Summary

The main objectives of this study are to evaluate the efficacy, safety, and tolerability of daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).

Conditions

Interventions

DRUG

PTG-100

Daily dosing of PTG-100 by subject for a 12 week treatment period.

DRUG

Placebo

Daily dosing of Placebo capsules by subject for a 12 week treatment period.

Sponsors & Collaborators

  • Protagonist Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Director Clinical Development · Protagonist Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-03-26
Completion
2018-03-26

Countries

  • United States
  • Australia
  • Belgium
  • Bosnia and Herzegovina
  • Canada
  • Croatia
  • Czechia
  • Germany
  • Hungary
  • Latvia
  • Netherlands
  • New Zealand
  • Poland
  • Russia
  • Serbia
  • South Korea
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT02895100 on ClinicalTrials.gov