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 (LOMBARD)

Applied Molecular Transport59 sites in 13 countries105 target enrollmentAugust 26, 2020

ConditionsUlcerative Colitis

InterventionsAMT-101 (oral)Placebo (oral)

DrugsAMT-101 (oral)

Overview

Phase: Phase 2
Intervention: AMT-101 (oral)
Conditions: Ulcerative Colitis
Sponsor: Applied Molecular Transport
Enrollment: 105
Locations: 59
Primary Endpoint: Change in Mayo Score
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Detailed Description

This is a Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study to evaluate the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.

Registry

clinicaltrials.gov

Start Date

August 26, 2020

End Date

December 31, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Applied Molecular Transport

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female subjects aged 18 to 75 years, inclusive.
•Diagnosis of moderate to severe UC.
•Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit.
•Able to participate fully in all aspects of this clinical trial.
•Written informed consent must be obtained and documented.

Exclusion Criteria

•Known gastrologic, or systemic condition that may compromise severity or diagnosis of disease.
•History or current evidence of colonic or abdominal abnormalities.
•Prohibited therapies or procedures before the screening period as specified per protocol.
•A concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study.
•Pregnant or lactating females.
•Current or recent history of alcohol dependence, illicit drug use, mental or legal incapacitation, or a history of clinically significant psychiatric disorders that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures.
•Unable to attend study visits or comply with procedures.
•Previous exposure to AMT-101 or similar and known hypersensitivity to AMT-101 or its excipients.