Clinical trial NCT05372939: Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Inflammatory Bowel Diseases
Lead sponsor: Applied Molecular Transport
Sponsor class: INDUSTRY
First posted: 2022-05-13
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline
timeFrame: 8 weeks
Secondary outcomes:
measure: Mean change in Robarts Histopathology Index (RHI) from baseline
timeFrame: 8 weeks
measure: Mean change in total Mayo Clinic Score (MCS) and component scores (Mayo Endoscopic Subscore [MES], partial MCS, rectal bleeding and stool frequency) from baseline
timeFrame: 8 weeks
measure: Mean change in fecal calprotectin from baseline
timeFrame: 8 weeks
measure: Mean change in high-sensitivity C-reactive protein (hs-CRP) from baseline
timeFrame: 8 weeks
measure: Proportion of subjects who achieve a significant reduction in RHI
timeFrame: 8 weeks
measure: Clinical remission rate
timeFrame: 8 weeks
measure: Clinical response rate
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Tbilisi
country: Georgia
facility: Arensia Exploratory Medicine GmbH Georgia
city: Amsterdam
country: Netherlands
facility: Academic Medical Center
city: Bydgoszcz
country: Poland
facility: NZOZ Vitamed
city: Chojnice
country: Poland
facility: Centrum Medyczne LukaMed Joanna Łuka-Wendrowska
city: Grudziądz
country: Poland
facility: Centrum Medyczne CLW-med Aneta Cichomska , Joanna Łuka -Wendrowska
city: Knurów
country: Poland
facility: Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
city: Piaseczno
country: Poland
facility: Centrum Innowacyjnych Terapii Sp. z o.o. Oddzial w Piasecznie
city: Rzeszów
country: Poland
facility: Centrum Medyczne Medyk
city: Tychy
country: Poland
facility: H.T. Centrum Medyczne - Endoterapia
city: Warszawa
country: Poland
facility: Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
city: Warszawa
country: Poland
facility: Bodyclinic sp z o.o. Sp. Kom.
city: Wrocław
country: Poland
facility: Centrum Medyczne Melita Medical
city: Kyiv
country: Ukraine
facility: Medical Center of Limited Liability Company "Harmoniya Krasy"
city: Kyiv
country: Ukraine
facility: Medical Center "OK!Clinic+" of International Institute of Clinical Research LLC, Gastroenterology and Hepatology unit of Hospital department
city: Kyiv
country: Ukraine
facility: Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Hospital", Therapeutic Department
city: Vinnytsia
country: Ukraine
facility: Municipal non-profit enterprise "Vinnytsia Regional Clinical Hospital named after M.I. Pirogov of Vinnytsia Regional Council", Regional Specialized Clinical gastroenterological Center
city: Vinnytsia
country: Ukraine
facility: Municipal non-profit enterprise "Vinnytsya City Clinical Hospital No1", Gastroenterology Department
city: Zhytomyr
country: Ukraine
facility: Medical Center of Limited Liability Company "Medibor", Department of Daycare, Day Surgery with Intensive Care Ward
Study officials:
References: