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

Phase 2

Terminated

• Conditions: Ulcerative Colitis
• Interventions: Drug: PTG-100; Drug: Placebo

• Registration Number: NCT02895100
• Lead Sponsor: Protagonist Therapeutics, Inc.

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.

Study Timeline

• Study First Submitted: 2016-09-04
• Study First Submitted QC: 2016-09-04
• Study First Posted: 2016-09-09
• Study Start: 2016-12-01
• Primary Completion: 2018-03-26
• Study Completion: 2018-03-26
• Disposition First Submitted: 2019-02-28
• Disposition First Submitted QC: 2019-02-28
• Disposition First Posted: 2019-03-05
• Results First Submitted: 2021-02-22
• Results First Submitted QC: 2021-02-22
• Results First Posted: 2021-03-22
• Status Verified: 2021-09
• Last Update Submitted: 2025-08-04
• Last Update Posted: 2025-08-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTG-100 (300 mg QD)	PTG-100	Medium dose
PTG-100 (900 mg QD)	PTG-100	High dose
Placebo group	Placebo	Placebo control
PTG-100 (150 mg QD)	PTG-100	Low dose

Primary Outcome Measures

Name	Time	Method
Proportion of Subjects Receiving PTG-100 With Clinical Remission at Week 12 Compared With Placebo	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.

Trial Locations

Locations (98)

Site Reference ID/Investigator # 101; 🇺🇸 Los Angeles, California, United States

Site Reference ID/Investigator # 102; 🇺🇸 Los Angeles, California, United States

Site Reference ID/Investigator # 125; 🇺🇸 Colorado Springs, Colorado, United States

Site Reference ID/Investigator # 120; 🇺🇸 Miami, Florida, United States

Site Reference ID/Investigator # 106; 🇺🇸 Port Orange, Florida, United States

Site Reference ID/Investigator # 115; 🇺🇸 Saint Augustine, Florida, United States

Site Reference ID/Investigator # 116; 🇺🇸 Sweetwater, Florida, United States

Site Reference ID/Investigator # 100; 🇺🇸 Atlanta, Georgia, United States

Site Reference ID/Investigator # 104; 🇺🇸 Marietta, Georgia, United States

Site Reference ID/Investigator # 112; 🇺🇸 Suwanee, Georgia, United States

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