A study of AMT-101 in patients with Pouchitis
Research type
Research Study
Full title
A Combined Phase 2/3 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
IRAS ID
285760
Contact name
Gordon Moran
Contact email
Sponsor organisation
Applied Molecular Transport Inc
Eudract number
2020-000048-73
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
AMT-101 is being developed to learn how safe and effective this medication is in participants with pouchitis.
This study is split into 2 parts. The first part will enroll up to 20 participants at approximately 40 sites in approximately 12 countries. The second part will enroll approximately 124 participants at approximately 40 sites in approximately 12 countries. Participants will be in this study for up to 20 weeks.
Blood, stool, urine, tissue and RNA samples will be collected for research purposes.
The first 20 participants will be enrolled into the study and will be randomly assigned to receive AMT-101 with a dose of either 3mg or 10mg. The results will be reviewed by an independent data monitoring committee. They will determine if the second part of this study will proceed, and which dose will be used.
If the study continues to the second part, participants will be randomly assigned to the AMT-101 or placebo group. Neither study participants nor the Study Doctor will know if they are receiving AMT-101 or placebo.Participants will be asked to come to the study clinic for 8 visits (Screening, Randomization (Day 1), Week 2, Week 6, Week 8, Week 10, Week 12, and Safety Follow Up). Additional visits may be required as needed. If participants are asked to discontinue the study prior to the Week 12 visit, they will be asked to complete an End of Treatment visit and come back for the Safety Follow Up Visit. If they withdraw consent to participate prior to the Week 12 visit, they will complete an End of Treatment (EOT) visit.
Participants will be asked to return for a safety follow-up visit 4 weeks after last dose of AMT-101 or placebo.
The study is paid for by Applied Molecular Transport Inc, the sponsor of this study.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0290
Date of REC Opinion
24 Sep 2020
REC opinion
Further Information Favourable Opinion