Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)
NCT ID: NCT04583358
Last Updated: 2022-11-07
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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UNKNOWN
PHASE2
105 participants
INTERVENTIONAL
2020-08-26
2022-12-31
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
AMT-101 Tablet
AMT-101 (oral)
AMT 101 is orally administered biological therapeutic taken once daily
Placebo
Placebo Tablet
Placebo (oral)
Orally administered placebo comparator taken once daily
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
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of moderate to severe UC.
* Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit.
* Able to participate fully in all aspects of this clinical trial.
* 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
80 Years
ALL
No
Sponsors
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Applied Molecular Transport
INDUSTRY
Responsible Party
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Locations
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Inland Empire Clinical Trials, LLC
Rialto, California, United States
AdventHealth - Florida Hospital
Orlando, Florida, United States
Advanced Medical Research Center
Port Orange, Florida, United States
Gwinnett Research Institute, LLC
Buford, Georgia, United States
Chevy Chase Clinical Research
Chevy Chase, Maryland, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan, United States
Carolina Research
Greenville, North Carolina, United States
Gastro One
Germantown, Tennessee, United States
GIA Clinical Trials, LLC
Knoxville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Caprock Gastro Research
Lubbock, Texas, United States
Tyler Research Institute, LLC
Tyler, Texas, United States
University of Utah Hospitals and Clinics
Salt Lake City, Utah, United States
Washington Gastroenterology
Bellevue, Washington, United States
Washington Gastroenterology, PLLC
Tacoma, Washington, United States
Vitebsk Regional Clinical Hospital
Vitebsk, Vitebsk Oblast, Belarus
MHAT Blagoevgrad AD
Blagoevgrad, , Bulgaria
MHAT Lyulin EAD
Sofia, , Bulgaria
GI Research Institute
Vancouver, British Columbia, Canada
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada
Toronto Digestive Disease Associates Specialty Research
Vaughan, Ontario, Canada
CHU Saint-Etienne - Hospital Nord Gastroenteroloy
Saint-Priest-en-Jarez, , France
Arensia Exploratory Medicine GmbH
Tbilisi, , Georgia
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Universitätsklinikum Jena Klinik fuer Innere Medizin IV
Jena, Thuringia, Germany
University Hospital Schleswig-Holstein
Kiel, , Germany
Staedtisches Klinikum Lueneburg
Lüneburg, , Germany
Mohacsi Korhaz
Mohács, Baranya, Hungary
Szegedi Tudomanyegyetem
Szeged, Csongrád megye, Hungary
Javorszky Odon Korhaz, Gasztroenterologiai Osztaly
Vác, Pest County, Hungary
Clinexpert Kft.
Budapest, , Hungary
Semmelweis Egyetem Altalanos Orvostudomanyi Kar
Budapest, , Hungary
Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E.M.
Chisinau, Municipality of Chisinau, Moldova
Centrum Medyczne CLW-MED
Grudziądz, Kuyavian-Pomeranian Voivodeship, Poland
Gastromed Kopon, Zmudziski I Wspolnicy Sp.j.
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Vistamed & Vertigo Sp. z o.o
Wroclaw, Lower Silesian Voivodeship, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovia, Poland
Nzoz Vivamed
Warsaw, Masovia, Poland
Endoskopia Sp. z o.o.
Sopot, Pomeranian Voivodeship, Poland
Centrum Medyczne LUKAMED Joanna Luka-Wendrowska
Chojnice, Pomeranian, Poland
Indywidualna Praktyka Lekarska Maciej Zymła
Knurów, Silesian, Poland
Vitamed Gałaj i Cichomski S.J.
Bydgoszcz, , Poland
Centrum Medyczne Medyk
Rzeszów, , Poland
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska S.J.
Ksawerów, Łódź Voivodeship, Poland
Nowe Zdrowie CK Kieltucki I Wspólnicy sp.j.
Staszów, Świętokrzyskie Voivodeship, Poland
Novosibirsk GastroCenter LLC
Novosibirsk, Novosibirsk Oblast, Russia
Medical Diagnostics Center, LLC
Yaroslavl, Yaroslavl Oblast, Russia
Clarunis Bauchzentrum
Basel, , Switzerland
Regional Hospital of War Veterans
Kharkiv, , Ukraine
Medical and Diagnostic Centre of Private Enterprise of Private Manufacturing Company "Acinus"
Kropyvnytskyi, , Ukraine
Medical center limited liability Harmoniya Krasy
Kyiv, , Ukraine
Medical Center Ok!Clinic+ International Institute
Kyiv, , Ukraine
CI of Kyiv RC Regional Clinical Hospital No 2
Kyiv, , Ukraine
Lviv Regional Clinical Hospital
Lviv, , Ukraine
Uzhgorod National University
Uzhhorod, , Ukraine
Vinnytsya City Clinical Hospital No 1
Vinnytsia, , Ukraine
Medical Center of Limited Liability Co
Zaporizhzhia, , Ukraine
Limited Liability Company Medibor
Zhytomyr, , Ukraine
Barnsley Hospital NHS Foundation Trust
Barnsley, Yorkshire, United Kingdom
Countries
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Other Identifiers
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AMT-101-202
Identifier Type: -
Identifier Source: org_study_id
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