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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination With Adalimumab in Subjects With Moderate to Severe Ulcerative Colitis

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: AMT-101 (oral)
* Other: Placebo (oral)
* Combination Product: Humira (adalimumab)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AMT-101 and Humira (adalimumab)<br>AMT-101 Tablet | Drug: AMT-101 (oral)<br>* AMT 101 is orally administered biological therapeutic taken once daily<br>Combination Product: Humira (adalimumab)<br>* Humira comparator is administered subcutaneously, on Humira frequency schedule.<br>|
| Placebo Comparator: Placebo and Humira (adalimumab)<br>Placebo Tablet | Other: Placebo (oral)<br>* Orally administered placebo comparator taken once daily<br>Combination Product: Humira (adalimumab)<br>* Humira comparator is administered subcutaneously, on Humira frequency schedule.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline | To evaluate the effects of AMT-101 in combination with adalimumab on ulcerative colitis (UC) disease activity | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Robarts Histopathology Index (RHI) from baseline |  | 8 weeks | 
| Mean change in total Mayo Clinic Score (MCS) and component scores (Mayo Endoscopic Subscore [MES], partial MCS, rectal bleeding and stool frequency) from baseline |  | 8 weeks | 
| Mean change in fecal calprotectin from baseline |  | 8 weeks | 
| Mean change in high-sensitivity C-reactive protein (hs-CRP) from baseline |  | 8 weeks | 
| Proportion of subjects who achieve a significant reduction in RHI |  | 8 weeks | 
| Clinical remission rate |  | 8 weeks | 
| Clinical response rate |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory Bowel Diseases