Status:
COMPLETED
Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET)
Lead Sponsor:
Applied Molecular Transport
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 ...
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 Combination with Adalimumab in Subjects with ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 13 2022
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT05372939
Start Date
February 5 2021
End Date
July 13 2022
Last Update
September 14 2022
Active Locations (18)
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1
Arensia Exploratory Medicine GmbH Georgia
Tbilisi, Georgia, 0112
2
Academic Medical Center
Amsterdam, Netherlands, 1105 AZ
3
NZOZ Vitamed
Bydgoszcz, Poland, 85-079
4
Centrum Medyczne LukaMed Joanna Łuka-Wendrowska
Chojnice, Poland, 89-600