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

Phase 2

Active, not recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: AMT-101 (oral); Other: Placebo (oral)

• Registration Number: NCT04583358
• Lead Sponsor: Applied Molecular Transport

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.

Study Timeline

• Study Start: 2020-08-26
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-07
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMT-101	AMT-101 (oral)	AMT-101 Tablet
Placebo	Placebo (oral)	Placebo Tablet

Primary Outcome Measures

Name	Time	Method
Change in Mayo Score	12 weeks

Secondary Outcome Measures

Name	Time	Method
Endoscopic Remission Rate	12 weeks
Mucosal Healing Rate	12 weeks
Histologic Remission Rate	12 weeks
Clinical Remission Rate	12 weeks

Trial Locations

Locations (59)

Inland Empire Clinical Trials, LLC; 🇺🇸 Rialto, California, United States

AdventHealth - Florida Hospital; 🇺🇸 Orlando, Florida, United States

Advanced Medical Research Center; 🇺🇸 Port Orange, Florida, United States

Gwinnett Research Institute, LLC; 🇺🇸 Buford, Georgia, United States

Chevy Chase Clinical Research; 🇺🇸 Chevy Chase, Maryland, United States

Huron Gastroenterology Associates; 🇺🇸 Ypsilanti, Michigan, United States

Carolina Research; 🇺🇸 Greenville, North Carolina, United States

Gastro One; 🇺🇸 Germantown, Tennessee, United States

GIA Clinical Trials, LLC; 🇺🇸 Knoxville, Tennessee, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Scroll for more (49 remaining)