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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05372939
• Other study ID #: AMT-101-203
• Status: Completed
• Phase: Phase 2
• Start date: February 5, 2021
• Est. completion date: July 13, 2022

Study information

• Verified date: September 2022
• Source: Applied Molecular Transport
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 13, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• AMT-101 (oral)
AMT 101 is orally administered biological therapeutic taken once daily

Other:
• Placebo (oral)
Orally administered placebo comparator taken once daily

Combination Product:
• Humira (adalimumab)
Humira comparator is administered subcutaneously, on Humira frequency schedule.

Locations

Country	Name	City	State
Georgia	Arensia Exploratory Medicine GmbH Georgia	Tbilisi
Netherlands	Academic Medical Center	Amsterdam
Poland	NZOZ Vitamed	Bydgoszcz
Poland	Centrum Medyczne LukaMed Joanna Luka-Wendrowska	Chojnice
Poland	Centrum Medyczne CLW-med Aneta Cichomska , Joanna Luka -Wendrowska	Grudziadz
Poland	Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla	Knurów
Poland	Centrum Innowacyjnych Terapii Sp. z o.o. Oddzial w Piasecznie	Piaseczno
Poland	Centrum Medyczne Medyk	Rzeszów
Poland	H.T. Centrum Medyczne - Endoterapia	Tychy
Poland	Bodyclinic sp z o.o. Sp. Kom.	Warszawa
Poland	Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz	Warszawa
Poland	Centrum Medyczne Melita Medical	Wroclaw
Ukraine	Medical Center "OK!Clinic+" of International Institute of Clinical Research LLC, Gastroenterology and Hepatology unit of Hospital department	Kyiv
Ukraine	Medical Center of Limited Liability Company "Harmoniya Krasy"	Kyiv
Ukraine	Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Hospital", Therapeutic Department	Kyiv
Ukraine	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	Medical Center of Limited Liability Company "Medibor", Department of Daycare, Day Surgery with Intensive Care Ward	Zhytomyr

Sponsors (1)

Lead Sponsor	Collaborator
Applied Molecular Transport

Countries where clinical trial is conducted

Georgia,  Netherlands,  Poland,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline	To evaluate the effects of AMT-101 in combination with adalimumab on ulcerative colitis (UC) disease activity	8 weeks
Secondary	Mean change in Robarts Histopathology Index (RHI) from baseline		8 weeks
Secondary	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
Secondary	Mean change in fecal calprotectin from baseline		8 weeks
Secondary	Mean change in high-sensitivity C-reactive protein (hs-CRP) from baseline		8 weeks
Secondary	Proportion of subjects who achieve a significant reduction in RHI		8 weeks
Secondary	Clinical remission rate		8 weeks
Secondary	Clinical response rate		8 weeks