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

NCT05372939 | Completed Phase 2 FDA Drug

• 1 other identifier: AMT-101-203
• Study Type: interventional
• Target: 51
• Locations: 4 countries
• Sites: 18

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.

Conditions

Ulcerative Colitis

Keywords

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• 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

Study Arms (2)

AMT-101 and Humira (adalimumab)

ACTIVE COMPARATOR

AMT-101 Tablet

Drug: AMT-101 (oral); Combination Product: Humira (adalimumab)

Placebo and Humira (adalimumab)

PLACEBO COMPARATOR

Placebo Tablet

Other: Placebo (oral); Combination Product: Humira (adalimumab)

Interventions

AMT-101 (oral) DRUG

AMT 101 is orally administered biological therapeutic taken once daily

AMT-101 and Humira (adalimumab)

Placebo (oral) OTHER

Orally administered placebo comparator taken once daily

Placebo and Humira (adalimumab)

Humira (adalimumab) COMBINATION_PRODUCT

Humira comparator is administered subcutaneously, on Humira frequency schedule.

AMT-101 and Humira (adalimumab); Placebo and Humira (adalimumab)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Applied Molecular Transport: lead

Study Sites (18)

Arensia Exploratory Medicine GmbH Georgia

Tbilisi, 0112, Georgia

Location

Academic Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

NZOZ Vitamed

Bydgoszcz, 85-079, Poland

Location

Centrum Medyczne LukaMed Joanna Łuka-Wendrowska

Chojnice, 89-600, Poland

Location

Centrum Medyczne CLW-med Aneta Cichomska , Joanna Łuka -Wendrowska

Grudziądz, 86-300, Poland

Location

Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

Knurów, 44-190, Poland

Location

Centrum Innowacyjnych Terapii Sp. z o.o. Oddzial w Piasecznie

Piaseczno, 05-500, Poland

Location

Centrum Medyczne Medyk

Rzeszów, 35-326, Poland

Location

H.T. Centrum Medyczne - Endoterapia

Tychy, 43-100, Poland

Location

Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz

Warsaw, 03-580, Poland

Location

Bodyclinic sp z o.o. Sp. Kom.

Warsaw, 03-712, Poland

Location

Centrum Medyczne Melita Medical

Wroclaw, 50-449, Poland

Location

Medical Center of Limited Liability Company "Harmoniya Krasy"

Kyiv, 01135, Ukraine

Location

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

Kyiv, 02091, Ukraine

Location

Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Hospital", Therapeutic Department

Kyiv, 04078, Ukraine

Location

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

Vinnytsia, 21028, Ukraine

Location

Municipal non-profit enterprise "Vinnytsya City Clinical Hospital No1", Gastroenterology Department

Vinnytsia, 21029, Ukraine

Location

Medical Center of Limited Liability Company "Medibor", Department of Daycare, Day Surgery with Intensive Care Ward

Zhytomyr, 10003, Ukraine

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: May 13, 2022
• Study Start: February 5, 2021
• Primary Completion: June 1, 2022
• Study Completion: July 13, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

GE (1); PL (10); NL (1); UA (6)