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

Ulcerative Colitis Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04583358
• Other study ID #: AMT-101-202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: August 26, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2022
• Source: Applied Molecular Transport
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 105
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• AMT-101 (oral)
AMT 101 is orally administered biological therapeutic taken once daily

Other:
• Placebo (oral)
Orally administered placebo comparator taken once daily

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Applied Molecular Transport

Countries where clinical trial is conducted

United States,  Belarus,  Bulgaria,  Canada,  France,  Georgia,  Germany,  Hungary,  Moldova, Republic of,  Poland,  Russian Federation,  Switzerland,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mayo Score		12 weeks
Secondary	Endoscopic Remission Rate		12 weeks
Secondary	Mucosal Healing Rate		12 weeks
Secondary	Histologic Remission Rate		12 weeks
Secondary	Clinical Remission Rate		12 weeks