A study of PRA023 in patients with Ulcerative Colitis
Research type
Research Study
Full title
A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis
IRAS ID
296345
Contact name
Sami Hoque
Contact email
Sponsor organisation
Prometheus Biosciences, Inc.
Eudract number
2021-000091-11
Clinicaltrials.gov Identifier
NCT0499679
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 5 months, 0 days
Research summary
PRA023 is being developed to learn how safe and effective this medication is in participants with ulcerative colitis.
This study will enrol approximately 170 participants in approximately 15 countries for approximately 1 year.
Blood, stool, urine, saliva, tissue and RNA samples will be collected, and genetic testing will be performed.
Participants will be randomly assigned to either PRA023 500mg or placebo study groups. Participants will have an equal chance of being assigned to either study drug medication or placebo.
Neither study participants nor the Study Doctor will know if they are receiving PRA023 or placebo. If there is a safety issue, the doctor can find out if the participant is receiving PRA023 or placebo.
Participants will be asked to come to the study site for a minimum of 19 visits.
Once assigned to a study group, participants will continue in that group for the 12-week Induction Period, where they will receive study medication or placebo every 2 weeks.
Participants may be involved in:
- Screening: (up to 5 weeks; 1 visit): participants will be assigned to 1 of 2 study groups.
- Induction: (12 weeks; 7 visits): Participants will take the study medication or placebo every 2 weeks.
- Open-Label Extension: Participants may take the study medication until they leave the study.
- Post Dosing Follow-up (12 weeks; 3 visits): Participants will be monitored for safety.If participants leave the study early, they will be asked to come to the study site for end-of-study evaluations and return to the site every 4 weeks for 12 weeks for post-study safety follow-up.
Participants will have the option to participate in a sub-study that involves additional blood sample collection at Week 0/Day 1 and Week 6.
The study is paid for by Prometheus Biosciences, Inc., the sponsor of this study.REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
21/NW/0136
Date of REC Opinion
27 Jul 2021
REC opinion
Further Information Favourable Opinion