A Phase 2 interventional study of AMT-101 (oral)-Dose A and AMT-101 (oral)-Dose B in Pouchitis, sponsored by Applied Molecular Transport. Completed at 34 sites in 10 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-09-14.
Sponsored by Applied Molecular Transport · Phase 2, Interventional, and Treatment
Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
A Phase 2 12-week, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis
50 studies on the registry are indexed under Pouchitis; 12 are open to participants now.
This study's enrollment of 22 is close to the median of 20 across 42 interventional studies indexed under Pouchitis.
Browse Pouchitis studies →Applied Molecular Transport is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dose A: AMT-101 Tablet
Drug: AMT-101 (oral)-Dose A
Dose B: AMT-101 Tablet
Drug: AMT-101 (oral)-Dose B
AMT-101 is an orally administered biologic therapeutic, taken once daily.
AMT-101 is an orally administered biologic therapeutic, taken once daily.
Stool Frequency Response
Time frame: 12 weeks
Histologic Healing
based upon the Geboes scoring system and PDAI
Time frame: 12 weeks
Histologic Response
based upon the Geboes scoring system and PDAI
Time frame: 12 weeks
Change in Endoscopic Score
Time frame: 12 weeks
Change in Stool Frequency
Time frame: 12 weeks
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Vimekofusp
Applied Molecular Transport