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

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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: AMT-101 (oral); Combination product: Humira (adalimumab); Other: Placebo (oral)

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• Georgia
  • Tbilisi, Georgia, 0112
    • Arensia Exploratory Medicine GmbH Georgia
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Academic Medical Center
• Poland
  • Bydgoszcz, Poland, 85-079
    • NZOZ Vitamed
  • Chojnice, Poland, 89-600
    • Centrum Medyczne LukaMed Joanna Łuka-Wendrowska
  • Grudziądz, Poland, 86-300
    • Centrum Medyczne CLW-med Aneta Cichomska , Joanna Łuka -Wendrowska
  • Knurów, Poland, 44-190
    • Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
  • Piaseczno, Poland, 05-500
    • Centrum Innowacyjnych Terapii Sp. z o.o. Oddzial w Piasecznie
  • Rzeszów, Poland, 35-326
    • Centrum Medyczne MEDYK
  • Tychy, Poland, 43-100
    • H.T. Centrum Medyczne - Endoterapia
  • Warszawa, Poland, 03-580
    • Niepubliczny Zakład Opieki Zdrowotnej VIVAMED Jadwiga Miecz
  • Warszawa, Poland, 03-712
    • Bodyclinic sp z o.o. Sp. Kom.
  • Wrocław, Poland, 50-449
    • Centrum Medyczne Melita Medical
• Ukraine
  • Kyiv, Ukraine, 01135
    • Medical Center of Limited Liability Company "Harmoniya Krasy"
  • Kyiv, Ukraine, 02091
    • Medical Center "OK!Clinic+" of International Institute of Clinical Research LLC, Gastroenterology and Hepatology unit of Hospital department
  • Kyiv, Ukraine, 04078
    • Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Hospital", Therapeutic Department
  • Vinnytsia, Ukraine, 21028
    • Municipal non-profit enterprise "Vinnytsia Regional Clinical Hospital named after M.I. Pirogov of Vinnytsia Regional Council", Regional Specialized Clinical gastroenterological Center
  • Vinnytsia, Ukraine, 21029
    • Municipal non-profit enterprise "Vinnytsya City Clinical Hospital No1", Gastroenterology Department
  • Zhytomyr, Ukraine, 10003
    • Medical Center of Limited Liability Company "Medibor", Department of Daycare, Day Surgery with Intensive Care Ward

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: AMT-101 and Humira (adalimumab); AMT-101 Tablet	Drug: AMT-101 (oral); AMT 101 is orally administered biological therapeutic taken once daily; Combination product: Humira (adalimumab); Humira comparator is administered subcutaneously, on Humira frequency schedule.
Placebo Comparator: Placebo and Humira (adalimumab); Placebo Tablet	Combination product: Humira (adalimumab); Humira comparator is administered subcutaneously, on Humira frequency schedule.; Other: Placebo (oral); Orally administered placebo comparator taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Clinical remission rate	8 weeks
Clinical response rate	8 weeks

Collaborators and Investigators

• Sponsor: Applied Molecular Transport

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): July 13, 2022

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: May 9, 2022
• First Posted (Actual): May 13, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Inflammatory Bowel Diseases
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: AMT-101-203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No