NCT02895100

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

A Phase 2b Randomised, Double-blind, Placebo-controlled, Parallel, Adaptive 2-Stage, Multi-Centre Study to Evaluate the Safety and Efficacy of Oral PTG-100 Induction in Subjects With Moderate to Severe Active Ulcerative Colitis

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 98 (actual)
• Sponsor: Protagonist Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This is a Phase II multi-centre, double blind, randomised, placebo-controlled, clinical study to evaluate the efficacy, safety, and tolerability of an oral peptide, PTG-100, administered as capsules for 12 weeks in subjects with moderate to severe UC. Following screening procedures and confirmation of subject eligibility, subjects will be randomised 1:1:1:1 to one of three daily doses of PTG-100 (150, 300 or 900 mg) or placebo. Stratification will be based on subjects' prior treatment with anti-TNF agents, with a maximum of 50% of subjects with prior unsuccessful anti-TNF agent treatments. Subjects will be treated with study drug for 12 weeks. Sigmoidoscopies will be performed at the Screening Visit and on Week 12. A final Follow Up Visit will occur on Week 16, when subject has been off study treatment for 4 weeks. Clinical, safety, pharmacokinetic (PK) and pharmacodynamic (PD) parameters will be evaluated on an ongoing basis during the 16 week study.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-12-01
• Primary completion: 2018-03-26
• Completion: 2018-03-26
• First posted: 2016-09-09
• Last updated: 2025-08-21
• Results posted: 2021-03-22

Locations

98 sites across 17 countries: United States, Australia, Belgium, Bosnia and Herzegovina, Canada, Croatia, Czechia, Germany, Hungary, Latvia, Netherlands, New Zealand, Poland, Russia, Serbia, South Korea, Ukraine