Overview

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

Status:
Active, not recruiting
Trial end date:
2022-09-30
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Applied Molecular Transport
Treatments:
Adalimumab
Criteria
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.