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

Phase 2

Completed

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

• Registration Number: NCT05372939
• 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 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.

Study Timeline

• Study Start: 2021-02-05
• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2022-05-09
• Study First Posted: 2022-05-13
• Primary Completion: 2022-06-01
• Study Completion: 2022-07-13
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMT-101 and Humira (adalimumab)	Humira (adalimumab)	AMT-101 Tablet
Placebo and Humira (adalimumab)	Placebo (oral)	Placebo Tablet
Placebo and Humira (adalimumab)	Humira (adalimumab)	Placebo Tablet
AMT-101 and Humira (adalimumab)	AMT-101 (oral)	AMT-101 Tablet

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (18)

NZOZ Vitamed; 🇵🇱 Bydgoszcz, Poland

Centrum Medyczne CLW-med Aneta Cichomska , Joanna Łuka -Wendrowska; 🇵🇱 Grudziądz, Poland

Centrum Medyczne Medyk; 🇵🇱 Rzeszów, Poland

Arensia Exploratory Medicine GmbH Georgia; 🇬🇪 Tbilisi, Georgia

Academic Medical Center; 🇳🇱 Amsterdam, Netherlands

Municipal non-profit enterprise "Vinnytsia Regional Clinical Hospital named after M.I. Pirogov of Vinnytsia Regional Council", Regional Specialized Clinical gastroenterological Center; 🇺🇦 Vinnytsia, Ukraine

Municipal non-profit enterprise "Vinnytsya City Clinical Hospital No1", Gastroenterology Department; 🇺🇦 Vinnytsia, Ukraine

Centrum Innowacyjnych Terapii Sp. z o.o. Oddzial w Piasecznie; 🇵🇱 Piaseczno, Poland

Bodyclinic sp z o.o. Sp. Kom.; 🇵🇱 Warszawa, Poland

Medical Center of Limited Liability Company "Harmoniya Krasy"; 🇺🇦 Kyiv, Ukraine

Medical Center "OK!Clinic+" of International Institute of Clinical Research LLC, Gastroenterology and Hepatology unit of Hospital department; 🇺🇦 Kyiv, Ukraine

Centrum Medyczne LukaMed Joanna Łuka-Wendrowska; 🇵🇱 Chojnice, Poland

Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla; 🇵🇱 Knurów, Poland

Centrum Medyczne Melita Medical; 🇵🇱 Wrocław, Poland

Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Hospital", Therapeutic Department; 🇺🇦 Kyiv, Ukraine

Medical Center of Limited Liability Company "Medibor", Department of Daycare, Day Surgery with Intensive Care Ward; 🇺🇦 Zhytomyr, Ukraine

Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz; 🇵🇱 Warszawa, Poland

H.T. Centrum Medyczne - Endoterapia; 🇵🇱 Tychy, Poland