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

Phase 2

Active, not recruiting

• Conditions: Ulcerative Colitis
• Interventions: Drug: AMT-101 (oral); Other: Placebo (oral)

• Registration Number: NCT04583358
• Lead Sponsor: Applied Molecular Transport

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.

Study Timeline

• Study Start: 2020-08-26
• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-10-05
• Study First Posted: 2020-10-12
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-03
• Last Update Posted: 2022-11-07
• Primary Completion: 2022-11-30
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 105

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMT-101	AMT-101 (oral)	AMT-101 Tablet
Placebo	Placebo (oral)	Placebo Tablet

Primary Outcome Measures

Name	Time	Method
Change in Mayo Score	12 weeks

Secondary Outcome Measures

Name	Time	Method
Endoscopic Remission Rate	12 weeks
Mucosal Healing Rate	12 weeks
Histologic Remission Rate	12 weeks
Clinical Remission Rate	12 weeks

Trial Locations

Locations (59)

Centrum Medyczne CLW-MED; 🇵🇱 Grudziadz, Kuyavian-Pomeranian, Poland

Medical center limited liability Harmoniya Krasy; 🇺🇦 Kyiv, Ukraine

Medical Center of Limited Liability Co; 🇺🇦 Zaporizhzhia, Ukraine

Staedtisches Klinikum Lueneburg; 🇩🇪 Lueneburg, Germany

Mohacsi Korhaz; 🇭🇺 Mohács, Baranya, Hungary

Clinexpert Kft.; 🇭🇺 Budapest, Hungary

Szegedi Tudomanyegyetem; 🇭🇺 Szeged, Csongrad, Hungary

Centrum Medyczne Medyk; 🇵🇱 Rzeszów, Poland

Regional Hospital of War Veterans; 🇺🇦 Kharkiv, Ukraine

Uzhgorod National University; 🇺🇦 Uzhgorod, Ukraine

WIP Warsaw IBD Point Profesor Kierkus; 🇵🇱 Warszawa, Masovia, Poland

Gastromed Kopon, Zmudziski I Wspolnicy Sp.j.; 🇵🇱 Toruń, Kuyavian-Pomeranian, Poland

Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Baden-Wurttemberg, Germany

Centrum Medyczne LUKAMED Joanna Luka-Wendrowska; 🇵🇱 Chojnice, Pomeranian, Poland

Clarunis Bauchzentrum; 🇨🇭 Basel, Switzerland

Nzoz Vivamed; 🇵🇱 Warszawa, Masovia, Poland

CHU Saint-Etienne - Hospital Nord Gastroenteroloy; 🇫🇷 Saint-Priest-en-Jarez, France

Lviv Regional Clinical Hospital; 🇺🇦 Lviv, Ukraine

Limited Liability Company Medibor; 🇺🇦 Zhytomyr, Ukraine

Javorszky Odon Korhaz, Gasztroenterologiai Osztaly; 🇭🇺 Vác, Pest, Hungary

Medical and Diagnostic Centre of Private Enterprise of Private Manufacturing Company "Acinus"; 🇺🇦 Kropyvnytskyi, Ukraine

CI of Kyiv RC Regional Clinical Hospital No 2; 🇺🇦 Kyiv, Ukraine

Vistamed & Vertigo Sp. z o.o; 🇵🇱 Wroclaw, Lower Silesian, Poland

Nowe Zdrowie CK Kieltucki I Wspólnicy sp.j.; 🇵🇱 Staszów, Swietokrzyskie, Poland

Novosibirsk GastroCenter LLC; 🇷🇺 Novosibirsk, Novosibirsk Oblast, Russian Federation

University of Utah Hospitals and Clinics; 🇺🇸 Salt Lake City, Utah, United States

Vitebsk Regional Clinical Hospital; 🇧🇾 Vitebsk, Viciebsk, Belarus

Inland Empire Clinical Trials, LLC; 🇺🇸 Rialto, California, United States

Caprock Gastro Research; 🇺🇸 Lubbock, Texas, United States

Washington Gastroenterology, PLLC; 🇺🇸 Tacoma, Washington, United States

GIA Clinical Trials, LLC; 🇺🇸 Knoxville, Tennessee, United States

MHAT Blagoevgrad AD; 🇧🇬 Blagoevgrad, Bulgaria

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Chevy Chase Clinical Research; 🇺🇸 Chevy Chase, Maryland, United States

MHAT Lyulin EAD; 🇧🇬 Sofia, Bulgaria

Indywidualna Praktyka Lekarska Maciej Zymła; 🇵🇱 Knurów, Silesian, Poland

Arensia Exploratory Medicine GmbH; 🇬🇪 Tbilisi, Georgia

Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E.M.; 🇲🇩 Chisinau, Municipality Of Chisinau, Moldova, Republic of

GI Research Institute; 🇨🇦 Vancouver, British Columbia, Canada

Gwinnett Research Institute, LLC; 🇺🇸 Buford, Georgia, United States

AdventHealth - Florida Hospital; 🇺🇸 Orlando, Florida, United States

Huron Gastroenterology Associates; 🇺🇸 Ypsilanti, Michigan, United States

Advanced Medical Research Center; 🇺🇸 Port Orange, Florida, United States

Carolina Research; 🇺🇸 Greenville, North Carolina, United States

Gastro One; 🇺🇸 Germantown, Tennessee, United States

Endoskopia Sp. z o.o.; 🇵🇱 Sopot, Pomorskie, Poland

Tyler Research Institute, LLC; 🇺🇸 Tyler, Texas, United States

London Health Sciences Centre - Victoria Hospital; 🇨🇦 London, Ontario, Canada

Washington Gastroenterology; 🇺🇸 Bellevue, Washington, United States

Universitätsklinikum Jena Klinik fuer Innere Medizin IV; 🇩🇪 Jena, Thuringia, Germany

University Hospital Schleswig-Holstein; 🇩🇪 Kiel, Germany

Toronto Digestive Disease Associates Specialty Research; 🇨🇦 Vaughan, Ontario, Canada

Semmelweis Egyetem Altalanos Orvostudomanyi Kar; 🇭🇺 Budapest, Hungary

Vitamed Gałaj i Cichomski S.J.; 🇵🇱 Bydgoszcz, Poland

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska S.J.; 🇵🇱 Ksawerów, Lodz, Poland

Medical Diagnostics Center, LLC; 🇷🇺 Yaroslavl, Yaroslavl Oblast, Russian Federation

Medical Center Ok!Clinic+ International Institute; 🇺🇦 Kyiv, Ukraine

Barnsley Hospital NHS Foundation Trust; 🇬🇧 Barnsley, Yorkshire, United Kingdom

Vinnytsya City Clinical Hospital No 1; 🇺🇦 Vinnytsya, Ukraine