- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05372939
Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET)
September 13, 2022 updated by: Applied Molecular Transport
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tbilisi, Georgia, 0112
- Arensia Exploratory Medicine GmbH Georgia
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Amsterdam, Netherlands, 1105 AZ
- Academic Medical Center
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Bydgoszcz, Poland, 85-079
- NZOZ Vitamed
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Chojnice, Poland, 89-600
- Centrum Medyczne LukaMed Joanna Łuka-Wendrowska
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Grudziądz, Poland, 86-300
- Centrum Medyczne CLW-med Aneta Cichomska , Joanna Łuka -Wendrowska
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Knurów, Poland, 44-190
- Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
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Piaseczno, Poland, 05-500
- Centrum Innowacyjnych Terapii Sp. z o.o. Oddzial w Piasecznie
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Rzeszów, Poland, 35-326
- Centrum Medyczne Medyk
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Tychy, Poland, 43-100
- H.T. Centrum Medyczne - Endoterapia
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Warszawa, Poland, 03-580
- Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
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Warszawa, Poland, 03-712
- Bodyclinic sp z o.o. Sp. Kom.
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Wrocław, Poland, 50-449
- Centrum Medyczne Melita Medical
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Kyiv, Ukraine, 01135
- Medical Center of Limited Liability Company "Harmoniya Krasy"
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Kyiv, Ukraine, 02091
- Medical Center "OK!Clinic+" of International Institute of Clinical Research LLC, Gastroenterology and Hepatology unit of Hospital department
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Kyiv, Ukraine, 04078
- Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Hospital", Therapeutic Department
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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
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Vinnytsia, Ukraine, 21029
- Municipal non-profit enterprise "Vinnytsya City Clinical Hospital No1", Gastroenterology Department
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Zhytomyr, Ukraine, 10003
- Medical Center of Limited Liability Company "Medibor", Department of Daycare, Day Surgery with Intensive Care Ward
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: AMT-101 and Humira (adalimumab)
AMT-101 Tablet
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AMT 101 is orally administered biological therapeutic taken once daily
Humira comparator is administered subcutaneously, on Humira frequency schedule.
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Placebo Comparator: Placebo and Humira (adalimumab)
Placebo Tablet
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Humira comparator is administered subcutaneously, on Humira frequency schedule.
Orally administered placebo comparator taken once daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline
Time Frame: 8 weeks
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To evaluate the effects of AMT-101 in combination with adalimumab on ulcerative colitis (UC) disease activity
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8 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Mean change in Robarts Histopathology Index (RHI) from baseline
Time Frame: 8 weeks
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8 weeks
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Mean change in total Mayo Clinic Score (MCS) and component scores (Mayo Endoscopic Subscore [MES], partial MCS, rectal bleeding and stool frequency) from baseline
Time Frame: 8 weeks
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8 weeks
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Mean change in fecal calprotectin from baseline
Time Frame: 8 weeks
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8 weeks
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Mean change in high-sensitivity C-reactive protein (hs-CRP) from baseline
Time Frame: 8 weeks
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8 weeks
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Proportion of subjects who achieve a significant reduction in RHI
Time Frame: 8 weeks
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8 weeks
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Clinical remission rate
Time Frame: 8 weeks
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8 weeks
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Clinical response rate
Time Frame: 8 weeks
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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