Clinical Trials/NCT05372939

NCT05372939

Completed

Phase 2

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

Applied Molecular Transport18 sites in 4 countries51 target enrollmentFebruary 5, 2021

ConditionsUlcerative Colitis

InterventionsAMT-101 (oral)Humira (adalimumab)Placebo (oral)

DrugsAMT-101 (oral)

Overview

Phase: Phase 2
Intervention: AMT-101 (oral)
Conditions: Ulcerative Colitis
Sponsor: Applied Molecular Transport
Enrollment: 51
Locations: 18
Primary Endpoint: Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 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 Combination with Adalimumab in Subjects with Moderate to Severe Ulcerative Colitis.

Registry

clinicaltrials.gov

Start Date

February 5, 2021

End Date

July 13, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Applied Molecular Transport

Responsible Party

Sponsor

Eligibility Criteria

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.

Arms & Interventions

AMT-101 and Humira (adalimumab)

AMT-101 Tablet

Intervention: AMT-101 (oral)

AMT-101 and Humira (adalimumab)

AMT-101 Tablet

Intervention: Humira (adalimumab)

Placebo and Humira (adalimumab)

Placebo Tablet

Intervention: Placebo (oral)

Placebo and Humira (adalimumab)

Placebo Tablet

Intervention: Humira (adalimumab)

Outcomes

Primary Outcomes

Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline

Time Frame: 8 weeks

To evaluate the effects of AMT-101 in combination with adalimumab on ulcerative colitis (UC) disease activity

Secondary Outcomes

Clinical response rate(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)
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)