Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET)
NCT ID: NCT05372939
Last Updated: 2022-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2021-02-05
2022-07-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AMT-101 and Humira (adalimumab)
AMT-101 Tablet
AMT-101 (oral)
AMT 101 is orally administered biological therapeutic taken once daily
Humira (adalimumab)
Humira comparator is administered subcutaneously, on Humira frequency schedule.
Placebo and Humira (adalimumab)
Placebo Tablet
Placebo (oral)
Orally administered placebo comparator taken once daily
Humira (adalimumab)
Humira comparator is administered subcutaneously, on Humira frequency schedule.
Interventions
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AMT-101 (oral)
AMT 101 is orally administered biological therapeutic taken once daily
Placebo (oral)
Orally administered placebo comparator taken once daily
Humira (adalimumab)
Humira comparator is administered subcutaneously, on Humira frequency schedule.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Applied Molecular Transport
INDUSTRY
Responsible Party
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Locations
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Arensia Exploratory Medicine GmbH Georgia
Tbilisi, , Georgia
Academic Medical Center
Amsterdam, , Netherlands
NZOZ Vitamed
Bydgoszcz, , Poland
Centrum Medyczne LukaMed Joanna Łuka-Wendrowska
Chojnice, , Poland
Centrum Medyczne CLW-med Aneta Cichomska , Joanna Łuka -Wendrowska
Grudziądz, , 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
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
Warsaw, , Poland
Bodyclinic sp z o.o. Sp. Kom.
Warsaw, , Poland
Centrum Medyczne Melita Medical
Wroclaw, , 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
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, , Ukraine
Countries
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Other Identifiers
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AMT-101-203
Identifier Type: -
Identifier Source: org_study_id
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