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
Phase of Trial: Phase II
Latest Information Update: 17 Apr 2018
At a glance
- Drugs PTG 100 (Primary)
- Indications Ulcerative colitis
- Focus Adverse reactions; Proof of concept; Therapeutic Use
- Acronyms PROPEL
- Sponsors Protagonist Therapeutics
- 26 Mar 2018 According to a Protagonist Therapeutics media release, this study has been discontinued, based on the interim analysis (n=65) of the primary endpoint of clinical remission by an independent Data Monitoring Committee (DMC). The DMC deemed the trial to be futile.
- 26 Mar 2018 Status changed from recruiting to discontinued, according to a Protagonist Therapeutics media release.
- 07 Mar 2018 According to a Protagonist Therapeutics media release, an interim futility analysis will be performed in the first quarter of 2018, and final top-line results are anticipated in the fourth quarter of 2018.