A study of AMT-101 in patients with Ulcerative Colitis
Research type
Research Study
Full title
A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis
IRAS ID
284932
Contact name
Jimmi Limdi
Contact email
Sponsor organisation
Applied Molecular Transport Inc.
Eudract number
2020-000047-31
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Summary of Research
AMT-101 is being developed to learn how safe and effective this medication is in participants with ulcerative colitis.
This study will enroll approximately 102 participants at approximately 80 sites in 20 countries, for approximately 20 weeks. Blood, stool, urine, tissue, and RNA samples will be collected for research purposes. A colonoscopy may be performed instead of a sigmoidoscopy at the screening visit if participants have not had a colonoscopy performed in the last 12 monthsParticipants will be randomly assigned to either AMT-101 3mg or placebo study groups. For every two participants who receive AMT-101, one will receive placebo. Neither study participants nor the Study Doctor will know if they are receiving AMT-101 or placebo through the entirety of the study. In case of an emergency or if there is a safety issue, the doctor can find out if the participant is receiving AMT-101 or placebo.
Participants will be asked to come in-person to the study clinic for approximately 6 visits in total (Screening, Randomization, Week 2, Week 6, Week 12, and Safety Follow Up visit). Additional visits may be required as needed (e.g., to repeat lab tests or if participant’s health changes). 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 participants withdraw consent to participate in the study prior to the Week 12 visit, they will be asked to complete an End of Treatment 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.
Summary of Results
AMT-101 appeared safe and well-tolerated. Similar clinical remission rates were observed in patients receiving AMT-101 compared to placebo.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
20/SC/0269
Date of REC Opinion
3 Aug 2020
REC opinion
Favourable Opinion