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

November 3, 2022 updated by: Applied Molecular Transport

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)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

105

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belarus
    • Viciebsk
      • Vitebsk, Viciebsk, Belarus, 210037
        • Vitebsk Regional Clinical Hospital
  • Bulgaria
      • Blagoevgrad, Bulgaria, 2700
        • MHAT Blagoevgrad AD
      • Sofia, Bulgaria, 1336
        • MHAT Lyulin EAD
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z2K5
        • GI Research Institute
    • Ontario
      • London, Ontario, Canada, N6A5W9
        • London Health Sciences Centre - Victoria Hospital
      • Vaughan, Ontario, Canada, L4L4Y7
        • Toronto Digestive Disease Associates Specialty Research
  • France
      • Saint-Priest-en-Jarez, France, 42270
        • CHU Saint-Etienne - Hospital Nord Gastroenteroloy
  • Georgia
      • Tbilisi, Georgia, 0112
        • Arensia Exploratory Medicine GmbH
  • Germany
      • Kiel, Germany, 24105
        • University Hospital Schleswig-Holstein
      • Lueneburg, Germany, 21339
        • Staedtisches Klinikum Lueneburg
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Universitätsklinikum Tübingen
    • Thuringia
      • Jena, Thuringia, Germany, 7747
        • Universitätsklinikum Jena Klinik fuer Innere Medizin IV
  • Hungary
      • Budapest, Hungary, 1033
        • Clinexpert Kft.
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem Általános Orvostudományi Kar
    • Baranya
      • Mohács, Baranya, Hungary, 7700
        • Mohacsi Korhaz
    • Csongrad
      • Szeged, Csongrad, Hungary, 6725
        • Szegedi Tudomanyegyetem
    • Pest
      • Vác, Pest, Hungary, 2600
        • Javorszky Odon Korhaz, Gasztroenterologiai Osztaly
  • Moldova, Republic of
    • Municipality Of Chisinau
      • Chisinau, Municipality Of Chisinau, Moldova, Republic of, MD-2025
        • Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E.M.
  • Poland
      • Bydgoszcz, Poland, 85079
        • Vitamed Gałaj i Cichomski S.J.
      • Rzeszów, Poland, 35326
        • Centrum Medyczne Medyk
    • Kuyavian-Pomeranian
      • Grudziadz, Kuyavian-Pomeranian, Poland, 86-300
        • Centrum Medyczne CLW-MED
      • Toruń, Kuyavian-Pomeranian, Poland, 87100
        • Gastromed Kopon, Zmudziski I Wspolnicy Sp.j.
    • Lodz
      • Ksawerów, Lodz, Poland, 95054
        • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska S.J.
    • Lower Silesian
      • Wroclaw, Lower Silesian, Poland, 54-144
        • Vistamed & Vertigo Sp. z o.o
    • Masovia
      • Warszawa, Masovia, Poland, 00728
        • WIP Warsaw IBD Point Profesor Kierkus
      • Warszawa, Masovia, Poland, 03-580
        • Nzoz Vivamed
    • Pomeranian
      • Chojnice, Pomeranian, Poland, 89-600
        • Centrum Medyczne Lukamed Joanna Luka-Wendrowska
    • Pomorskie
      • Sopot, Pomorskie, Poland, 81756
        • ENDOSKOPIA Sp. z o.o.
    • Silesian
      • Knurów, Silesian, Poland, 44190
        • Indywidualna Praktyka Lekarska Maciej Zymła
    • Swietokrzyskie
      • Staszów, Swietokrzyskie, Poland, 28200
        • Nowe Zdrowie CK Kieltucki I Wspólnicy sp.j.
  • Russian Federation
    • Novosibirsk Oblast
      • Novosibirsk, Novosibirsk Oblast, Russian Federation, 630007
        • Novosibirsk GastroCenter LLC
    • Yaroslavl Oblast
      • Yaroslavl, Yaroslavl Oblast, Russian Federation, 150000
        • Medical Diagnostics Center, LLC
  • Switzerland
      • Basel, Switzerland, 4031
        • Clarunis Bauchzentrum
  • Ukraine
      • Kharkiv, Ukraine, 61019
        • Regional Hospital of War Veterans
      • Kropyvnytskyi, Ukraine, 25006
        • Medical and Diagnostic Centre of Private Enterprise of Private Manufacturing Company "Acinus"
      • Kyiv, Ukraine, 01135
        • Medical center limited liability Harmoniya Krasy
      • Kyiv, Ukraine, 02091
        • Medical Center Ok!Clinic+ International Institute
      • Kyiv, Ukraine, 04073
        • CI of Kyiv RC Regional Clinical Hospital No 2
      • Lviv, Ukraine, 79010
        • Lviv Regional Clinical Hospital
      • Uzhgorod, Ukraine, 88009
        • Uzhgorod National University
      • Vinnytsya, Ukraine, 21029
        • Vinnytsya City Clinical Hospital No 1
      • Zaporizhzhia, Ukraine, 69076
        • Medical Center of Limited Liability Co
      • Zhytomyr, Ukraine, 10003
        • Limited Liability Company Medibor
  • United Kingdom
    • Yorkshire
      • Barnsley, Yorkshire, United Kingdom, S75 2EP
        • Barnsley Hospital NHS Foundation Trust
  • United States
    • California
      • Rialto, California, United States, 92377
        • Inland Empire Clinical Trials, LLC
    • Florida
      • Orlando, Florida, United States, 32803
        • AdventHealth - Florida Hospital
      • Port Orange, Florida, United States, 32127
        • Advanced Medical Research Center
    • Georgia
      • Buford, Georgia, United States, 30519
        • Gwinnett Research Institute, LLC
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Chevy Chase Clinical Research
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Huron Gastroenterology Associates
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Carolina Research
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Knoxville, Tennessee, United States, 37909
        • GIA Clinical Trials, LLC
      • Nashville, Tennessee, United States, 37212-1375
        • Vanderbilt University Medical Center
    • Texas
      • Lubbock, Texas, United States, 79424
        • Caprock Gastro Research
      • Tyler, Texas, United States, 75701
        • Tyler Research Institute, LLC
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah Hospitals and Clinics
    • Washington
      • Bellevue, Washington, United States, 38004
        • Washington Gastroenterology
      • Tacoma, Washington, United States, 98405
        • Washington Gastroenterology, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo Tablet
Other: Placebo (oral)
Orally administered placebo comparator taken once daily
Active Comparator: AMT-101
AMT-101 Tablet
Drug: AMT-101 (oral)
AMT 101 is orally administered biological therapeutic taken once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Mayo Score
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Endoscopic Remission Rate
Time Frame: 12 weeks
12 weeks
Mucosal Healing Rate
Time Frame: 12 weeks
12 weeks
Histologic Remission Rate
Time Frame: 12 weeks
12 weeks
Clinical Remission Rate
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Applied Molecular Transport

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2020

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

September 16, 2020

First Submitted That Met QC Criteria

October 5, 2020

First Posted (Actual)

October 12, 2020

Study Record Updates

Last Update Posted (Actual)

November 7, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMT-101-202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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