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

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)

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04583358

Enrollment

105

Registered

2020-10-12

Start date

2020-08-26

Completion date

2022-12-31

Last updated

2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ulcerative Colitis

Keywords

Inflammatory Bowel Diseases

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.

Interventions

DRUGAMT-101 (oral)

AMT 101 is orally administered biological therapeutic taken once daily

OTHERPlacebo (oral)

Orally administered placebo comparator taken once daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Change in Mayo Score	12 weeks

Secondary

Measure	Time frame
Endoscopic Remission Rate	12 weeks
Mucosal Healing Rate	12 weeks
Histologic Remission Rate	12 weeks
Clinical Remission Rate	12 weeks

Countries

Belarus, Bulgaria, Canada, France, Georgia, Germany, Hungary, Moldova, Poland, Russia, Switzerland, Ukraine, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026