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

Study Overview
=================
Brief Summary
-----------------
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.

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 Subjects with Moderate to Severe Ulcerative Colitis.

Official Title
-----------------
A 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 (LOMBARD)

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: AMT-101 (oral)
* Other: Placebo (oral)


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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<br>AMT-101 Tablet | Drug: AMT-101 (oral)<br>* AMT 101 is orally administered biological therapeutic taken once daily<br>|
| Placebo Comparator: Placebo<br>Placebo Tablet | Other: Placebo (oral)<br>* Orally administered placebo comparator taken once daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mayo Score |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic Remission Rate |  | 12 weeks | 
| Mucosal Healing Rate |  | 12 weeks | 
| Histologic Remission Rate |  | 12 weeks | 
| Clinical Remission Rate |  | 12 weeks | 

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