Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)

Applied Molecular Transport

Status and phase

Active, not recruiting

Phase 2

Conditions

Ulcerative Colitis

Treatments

Other: Placebo (oral)

Drug: AMT-101 (oral)

Study type

Interventional

Funder types

Industry

Identifiers

NCT04583358

AMT-101-202

Details and patient eligibility

About

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.

Full 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.

Enrollment

105 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.