A phase 1b study of PT101 in patients with Ulcerative Colitis
Research type
Research Study
Full title
A Phase 1b, Randomized, Adaptive, Double-Blind, Placebo-Controlled, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of PT101 in Subjects with Active Ulcerative Colitis
IRAS ID
298285
Contact name
Sam Leving
Contact email
Sponsor organisation
Pandion Therapeutics, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA
Eudract number
2021-000093-28
Duration of Study in the UK
2 years, 3 months, 2 days
Research summary
PT101 is being developed to learn how safe and tolerable this medication is in participants with ulcerative colitis.
This study will enroll approximately 60 participants in approximately 8 countries for approximately 1 year or longer.
Blood, stool, urine, and colonic biopsy tissue samples will be collected, and optional genetic testing will be performed.
Participants will be randomly assigned to 1 of up to 6 cohorts, Chances of receiving either PT101 or placebo will remain the same across all cohorts. Study participants in these cohorts have an 80% percent chance of being assigned to PT101 or 20% chance of placebo.
Neither study participants nor the Study Doctor will know if they are receiving PT101 or placebo. If there is a safety issue, the doctor can find out what the participant is receiving.
A Data Review Committee will review the safety data for the first five study participants after their first 2 doses and determine if it is safe to continue and if the expected dose and procedures for the next cohort(s) need to be modified. The DRC may decide to add up to three additional cohorts to the study.
Participants may be involved in the following study periods:
Screening (up to 4 weeks, approximately 2 visits)
Initial Treatment period (12-14 weeks, 12-20 visits)
Open label treatment or continuation of blinded treatment period (40 weeks, 10-19 visits)
Participation may last up to a maximum of 57 weeks. In some circumstances, for example if participants health changes or a test needs repeating, they may also be asked to go to the study site for extra visits.
The study is paid for by Pandion Therapeutics, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA, (known as MSD outside the United States and Canada) the sponsor of this study.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
21/EM/0173
Date of REC Opinion
10 Sep 2021
REC opinion
Further Information Favourable Opinion