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

Applied Molecular Transport

Status and phase: Completed; Phase 2

Conditions: Ulcerative Colitis

Treatments: Combination Product: Humira (adalimumab); Drug: AMT-101 (oral); Other: Placebo (oral)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05372939

AMT-101-203

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 Combination With Adalimumab 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 Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis.

Enrollment: 51 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female subjects aged 18 to 75 years.
• Moderate to severe UC.
• Eligible for Humira (adalimumab) therapy.
• Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

AMT-101 and Humira (adalimumab)

Active Comparator group

Description:

AMT-101 Tablet

Treatment:

Drug: AMT-101 (oral)

Combination Product: Humira (adalimumab)

Placebo and Humira (adalimumab)

Placebo Comparator group

Description:

Placebo Tablet

Treatment:

Other: Placebo (oral)

Combination Product: Humira (adalimumab)