Clinical trial NCT04583358: Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)
Official title: A 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 (LOMBARD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Inflammatory Bowel Diseases
Lead sponsor: Applied Molecular Transport
Sponsor class: INDUSTRY
First posted: 2020-10-12
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
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 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 Subjects with Moderate to Severe Ulcerative Colitis.

Eligibility criteria: Inclusion Criteria:

* 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.

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: Change in Mayo Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Endoscopic Remission Rate
timeFrame: 12 weeks
measure: Mucosal Healing Rate
timeFrame: 12 weeks
measure: Histologic Remission Rate
timeFrame: 12 weeks
measure: Clinical Remission Rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Rialto
country: United States
facility: Inland Empire Clinical Trials, LLC
state: California
city: Orlando
country: United States
facility: AdventHealth - Florida Hospital
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Buford
country: United States
facility: Gwinnett Research Institute, LLC
state: Georgia
city: Chevy Chase
country: United States
facility: Chevy Chase Clinical Research
state: Maryland
city: Ypsilanti
country: United States
facility: Huron Gastroenterology Associates
state: Michigan
city: Greenville
country: United States
facility: Carolina Research
state: North Carolina
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Knoxville
country: United States
facility: GIA Clinical Trials, LLC
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Lubbock
country: United States
facility: Caprock Gastro Research
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospitals and Clinics
state: Utah
city: Bellevue
country: United States
facility: Washington Gastroenterology
state: Washington
city: Tacoma
country: United States
facility: Washington Gastroenterology, PLLC
state: Washington
city: Vitebsk
country: Belarus
facility: Vitebsk Regional Clinical Hospital
state: Viciebsk
city: Blagoevgrad
country: Bulgaria
facility: MHAT Blagoevgrad AD
city: Sofia
country: Bulgaria
facility: MHAT Lyulin EAD
city: Vancouver
country: Canada
facility: GI Research Institute
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre - Victoria Hospital
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates Specialty Research
state: Ontario
city: Saint-Priest-en-Jarez
country: France
facility: CHU Saint-Etienne - Hospital Nord Gastroenteroloy
city: Tbilisi
country: Georgia
facility: Arensia Exploratory Medicine GmbH
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
state: Baden-Wurttemberg
city: Jena
country: Germany
facility: Universitätsklinikum Jena Klinik fuer Innere Medizin IV
state: Thuringia
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein
city: Lueneburg
country: Germany
facility: Staedtisches Klinikum Lueneburg
city: Mohács
country: Hungary
facility: Mohacsi Korhaz
state: Baranya
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem
state: Csongrad
city: Vác
country: Hungary
facility: Javorszky Odon Korhaz, Gasztroenterologiai Osztaly
state: Pest
city: Budapest
country: Hungary
facility: Clinexpert Kft.
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Altalanos Orvostudomanyi Kar
city: Chisinau
country: Moldova, Republic of
facility: Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E.M.
state: Municipality Of Chisinau
city: Grudziadz
country: Poland
facility: Centrum Medyczne CLW-MED
state: Kuyavian-Pomeranian
city: Toruń
country: Poland
facility: Gastromed Kopon, Zmudziski I Wspolnicy Sp.j.
state: Kuyavian-Pomeranian
city: Ksawerów
country: Poland
facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska S.J.
state: Lodz
city: Wroclaw
country: Poland
facility: Vistamed & Vertigo Sp. z o.o
state: Lower Silesian
city: Warszawa
country: Poland
facility: WIP Warsaw IBD Point Profesor Kierkus
state: Masovia
city: Warszawa
country: Poland
facility: Nzoz Vivamed
state: Masovia
city: Chojnice
country: Poland
facility: Centrum Medyczne LUKAMED Joanna Luka-Wendrowska
state: Pomeranian
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
state: Pomorskie
city: Knurów
country: Poland
facility: Indywidualna Praktyka Lekarska Maciej Zymła
state: Silesian
city: Staszów
country: Poland
facility: Nowe Zdrowie CK Kieltucki I Wspólnicy sp.j.
state: Swietokrzyskie
city: Bydgoszcz
country: Poland
facility: Vitamed Gałaj i Cichomski S.J.
city: Rzeszów
country: Poland
facility: Centrum Medyczne Medyk
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk GastroCenter LLC
state: Novosibirsk Oblast
city: Yaroslavl
country: Russian Federation
facility: Medical Diagnostics Center, LLC
state: Yaroslavl Oblast
city: Basel
country: Switzerland
facility: Clarunis Bauchzentrum
city: Kharkiv
country: Ukraine
facility: Regional Hospital of War Veterans
city: Kropyvnytskyi
country: Ukraine
facility: Medical and Diagnostic Centre of Private Enterprise of Private Manufacturing Company "Acinus"
city: Kyiv
country: Ukraine
facility: Medical center limited liability Harmoniya Krasy
city: Kyiv
country: Ukraine
facility: Medical Center Ok!Clinic+ International Institute
city: Kyiv
country: Ukraine
facility: CI of Kyiv RC Regional Clinical Hospital No 2
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital
city: Uzhgorod
country: Ukraine
facility: Uzhgorod National University
city: Vinnytsya
country: Ukraine
facility: Vinnytsya City Clinical Hospital No 1
city: Zaporizhzhia
country: Ukraine
facility: Medical Center of Limited Liability Co
city: Zhytomyr
country: Ukraine
facility: Limited Liability Company Medibor
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS Foundation Trust
state: Yorkshire
Study officials:
References: