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

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.

Key facts

Study ID

NCT04583358

Run by

Applied Molecular Transport

People needed

105

Starts

2020-08-26

Expected to finish

2022-12-31

Last updated by the study team

2022-11-07

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects aged 18 to 75 years, inclusive.
• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• Inland Empire Clinical Trials, LLC — Rialto, California, United States

Full record on ClinicalTrials.gov

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