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Study of the Safety and Efficacy of AMT-101 in Subjects With Pouchitis

NCT04741087 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2022-09-14

No results posted yet for this study

Summary

Phase 2 Study Investigating the Efficacy of AMT-101 in Subjects with Chronic Antibiotic-resistant Pouchitis

Conditions

  • Pouchitis

Interventions

DRUG

AMT-101 (oral)-Dose A

AMT-101 is an orally administered biologic therapeutic, taken once daily.

DRUG

AMT-101 (oral)-Dose B

AMT-101 is an orally administered biologic therapeutic, taken once daily.

Sponsors & Collaborators

  • Applied Molecular Transport

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-05
Primary Completion
2022-03-11
Completion
2022-04-22
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • France
  • Germany
  • Hungary
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04741087 on ClinicalTrials.gov