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

NCT04583358 | Unknown Phase 2 FDA Drug

• 1 other identifier: AMT-101-202
• Study Type: interventional
• Target: 105
• Locations: 14 countries
• Sites: 59

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.

Conditions

Ulcerative Colitis

Keywords

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• Change in Mayo Score

  12 weeks

Secondary Outcomes (4)

• Endoscopic Remission Rate

  12 weeks

• Mucosal Healing Rate

  12 weeks

• Histologic Remission Rate

  12 weeks

• Clinical Remission Rate

  12 weeks

Study Arms (2)

AMT-101

ACTIVE COMPARATOR

AMT-101 Tablet

Drug: AMT-101 (oral)

Placebo

PLACEBO COMPARATOR

Placebo Tablet

Other: Placebo (oral)

Interventions

AMT-101 (oral) DRUG

AMT 101 is orally administered biological therapeutic taken once daily

AMT-101

Placebo (oral) OTHER

Orally administered placebo comparator taken once daily

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Applied Molecular Transport: lead

Study Sites (59)

Inland Empire Clinical Trials, LLC

Rialto, California, 92377, United States

Location

AdventHealth - Florida Hospital

Orlando, Florida, 32803, United States

Location

Advanced Medical Research Center

Port Orange, Florida, 32127, United States

Location

Gwinnett Research Institute, LLC

Buford, Georgia, 30519, United States

Location

Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, United States

Location

Huron Gastroenterology Associates

Ypsilanti, Michigan, 48197, United States

Location

Carolina Research

Greenville, North Carolina, 27834, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

GIA Clinical Trials, LLC

Knoxville, Tennessee, 37909, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37212-1375, United States

Location

Caprock Gastro Research

Lubbock, Texas, 79424, United States

Location

Tyler Research Institute, LLC

Tyler, Texas, 75701, United States

Location

University of Utah Hospitals and Clinics

Salt Lake City, Utah, 84112, United States

Location

Washington Gastroenterology

Bellevue, Washington, 38004, United States

Location

Washington Gastroenterology, PLLC

Tacoma, Washington, 98405, United States

Location

Vitebsk Regional Clinical Hospital

Vitebsk, Vitebsk Oblast, 210037, Belarus

Location

MHAT Blagoevgrad AD

Blagoevgrad, 2700, Bulgaria

Location

MHAT Lyulin EAD

Sofia, 1336, Bulgaria

Location

GI Research Institute

Vancouver, British Columbia, V6Z2K5, Canada

Location

London Health Sciences Centre - Victoria Hospital

London, Ontario, N6A5W9, Canada

Location

Toronto Digestive Disease Associates Specialty Research

Vaughan, Ontario, L4L4Y7, Canada

Location

CHU Saint-Etienne - Hospital Nord Gastroenteroloy

Saint-Priest-en-Jarez, 42270, France

Location

Arensia Exploratory Medicine GmbH

Tbilisi, 0112, Georgia

Location

Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitätsklinikum Jena Klinik fuer Innere Medizin IV

Jena, Thuringia, 7747, Germany

Location

University Hospital Schleswig-Holstein

Kiel, 24105, Germany

Location

Staedtisches Klinikum Lueneburg

Lüneburg, 21339, Germany

Location

Mohacsi Korhaz

Mohács, Baranya, 7700, Hungary

Location

Szegedi Tudomanyegyetem

Szeged, Csongrád megye, 6725, Hungary

Location

Javorszky Odon Korhaz, Gasztroenterologiai Osztaly

Vác, Pest County, 2600, Hungary

Location

Clinexpert Kft.

Budapest, 1033, Hungary

Location

Semmelweis Egyetem Altalanos Orvostudomanyi Kar

Budapest, 1083, Hungary

Location

Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E.M.

Chisinau, Municipality of Chisinau, MD-2025, Moldova

Location

Centrum Medyczne CLW-MED

Grudziądz, Kuyavian-Pomeranian Voivodeship, 86-300, Poland

Location

Gastromed Kopon, Zmudziski I Wspolnicy Sp.j.

Torun, Kuyavian-Pomeranian Voivodeship, 87100, Poland

Location

Vistamed & Vertigo Sp. z o.o

Wroclaw, Lower Silesian Voivodeship, 54-144, Poland

Location

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Masovia, 00728, Poland

Location

Nzoz Vivamed

Warsaw, Masovia, 03-580, Poland

Location

Endoskopia Sp. z o.o.

Sopot, Pomeranian Voivodeship, 81756, Poland

Location

Centrum Medyczne LUKAMED Joanna Luka-Wendrowska

Chojnice, Pomeranian, 89-600, Poland

Location

Indywidualna Praktyka Lekarska Maciej Zymła

Knurów, Silesian, 44190, Poland

Location

Vitamed Gałaj i Cichomski S.J.

Bydgoszcz, 85079, Poland

Location

Centrum Medyczne Medyk

Rzeszów, 35326, Poland

Location

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska S.J.

Ksawerów, Łódź Voivodeship, 95054, Poland

Location

Nowe Zdrowie CK Kieltucki I Wspólnicy sp.j.

Staszów, Świętokrzyskie Voivodeship, 28200, Poland

Location

Novosibirsk GastroCenter LLC

Novosibirsk, Novosibirsk Oblast, 630007, Russia

Location

Medical Diagnostics Center, LLC

Yaroslavl, Yaroslavl Oblast, 150000, Russia

Location

Clarunis Bauchzentrum

Basel, 4031, Switzerland

Location

Regional Hospital of War Veterans

Kharkiv, 61019, Ukraine

Location

Medical and Diagnostic Centre of Private Enterprise of Private Manufacturing Company "Acinus"

Kropyvnytskyi, 25006, Ukraine

Location

Medical center limited liability Harmoniya Krasy

Kyiv, 01135, Ukraine

Location

Medical Center Ok!Clinic+ International Institute

Kyiv, 02091, Ukraine

Location

CI of Kyiv RC Regional Clinical Hospital No 2

Kyiv, 04073, Ukraine

Location

Lviv Regional Clinical Hospital

Lviv, 79010, Ukraine

Location

Uzhgorod National University

Uzhhorod, 88009, Ukraine

Location

Vinnytsya City Clinical Hospital No 1

Vinnytsia, 21029, Ukraine

Location

Medical Center of Limited Liability Co

Zaporizhzhia, 69076, Ukraine

Location

Limited Liability Company Medibor

Zhytomyr, 10003, Ukraine

Location

Barnsley Hospital NHS Foundation Trust

Barnsley, Yorkshire, S75 2EP, United Kingdom

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: October 12, 2020
• Study Start: August 26, 2020
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: November 7, 2022

Record last verified: 2022-11

Locations

HU (5); US (15); DE (4); RU (2); UA (10); GB (1); BE (1); FR (1); PL (12); GE (1); BU (2); MO (1); CH (1); CA (3)