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
Overview
- Phase
- Phase 2
- Intervention
- PTG-100
- Conditions
- Ulcerative Colitis
- Sponsor
- Protagonist Therapeutics, Inc.
- Enrollment
- 98
- Locations
- 98
- Primary Endpoint
- Proportion of Subjects Receiving PTG-100 With Clinical Remission at Week 12 Compared With Placebo
- Status
- Terminated
- Last Updated
- 8 months ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
PTG-100 (150 mg QD)
Low dose
Intervention: PTG-100
PTG-100 (300 mg QD)
Medium dose
Intervention: PTG-100
PTG-100 (900 mg QD)
High dose
Intervention: PTG-100
Placebo group
Placebo control
Intervention: Placebo
Outcomes
Primary Outcomes
Proportion of Subjects Receiving PTG-100 With Clinical Remission at Week 12 Compared With Placebo
Time Frame: 12 week treatment period
The primary efficacy endpoint for this study was the proportion of subjects receiving PTG-100 with clinical remission at Week 12. Clinical remission was defined using the Mayo subscores of stool frequency, rectal bleeding, and endoscopy.