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

Primary Purpose

Ulcerative Colitis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AMT-101 (oral)
Placebo (oral)
Sponsored by
Applied Molecular Transport
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Inland Empire Clinical Trials, LLC
  • AdventHealth - Florida Hospital
  • Advanced Medical Research Center
  • Gwinnett Research Institute, LLC
  • Chevy Chase Clinical Research
  • Huron Gastroenterology Associates
  • Carolina Research
  • Gastro One
  • GIA Clinical Trials, LLC
  • Vanderbilt University Medical Center
  • Caprock Gastro Research
  • Tyler Research Institute, LLC
  • University of Utah Hospitals and Clinics
  • Washington Gastroenterology
  • Washington Gastroenterology, PLLC
  • Vitebsk Regional Clinical Hospital
  • MHAT Blagoevgrad AD
  • MHAT Lyulin EAD
  • GI Research Institute
  • London Health Sciences Centre - Victoria Hospital
  • Toronto Digestive Disease Associates Specialty Research
  • CHU Saint-Etienne - Hospital Nord Gastroenteroloy
  • Arensia Exploratory Medicine GmbH
  • Universitätsklinikum Tübingen
  • Universitätsklinikum Jena Klinik fuer Innere Medizin IV
  • University Hospital Schleswig-Holstein
  • Staedtisches Klinikum Lueneburg
  • Mohacsi Korhaz
  • Szegedi Tudomanyegyetem
  • Javorszky Odon Korhaz, Gasztroenterologiai Osztaly
  • Clinexpert Kft.
  • Semmelweis Egyetem Altalanos Orvostudomanyi Kar
  • Clinical Republican Hospital "Timofei Mosneaga", ARENSIA E.M.
  • Centrum Medyczne CLW-MED
  • Gastromed Kopon, Zmudziski I Wspolnicy Sp.j.
  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska S.J.
  • Vistamed & Vertigo Sp. z o.o
  • WIP Warsaw IBD Point Profesor Kierkus
  • Nzoz Vivamed
  • Centrum Medyczne LUKAMED Joanna Luka-Wendrowska
  • Endoskopia Sp. z o.o.
  • Indywidualna Praktyka Lekarska Maciej Zymła
  • Nowe Zdrowie CK Kieltucki I Wspólnicy sp.j.
  • Vitamed Gałaj i Cichomski S.J.
  • Centrum Medyczne Medyk
  • Novosibirsk GastroCenter LLC
  • Medical Diagnostics Center, LLC
  • Clarunis Bauchzentrum
  • Regional Hospital of War Veterans
  • Medical and Diagnostic Centre of Private Enterprise of Private Manufacturing Company "Acinus"
  • Medical center limited liability Harmoniya Krasy
  • Medical Center Ok!Clinic+ International Institute
  • CI of Kyiv RC Regional Clinical Hospital No 2
  • Lviv Regional Clinical Hospital
  • Uzhgorod National University
  • Vinnytsya City Clinical Hospital No 1
  • Medical Center of Limited Liability Co
  • Limited Liability Company Medibor
  • Barnsley Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AMT-101

Placebo

Arm Description

AMT-101 Tablet

Placebo Tablet

Outcomes

Primary Outcome Measures

Change in Mayo Score

Secondary Outcome Measures

Endoscopic Remission Rate
Mucosal Healing Rate
Histologic Remission Rate
Clinical Remission Rate

Full Information

First Posted
September 16, 2020
Last Updated
November 3, 2022
Sponsor
Applied Molecular Transport
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1. Study Identification

Unique Protocol Identification Number
NCT04583358
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 26, 2020 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Applied Molecular Transport

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Inflammatory Bowel Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AMT-101
Arm Type
Active Comparator
Arm Description
AMT-101 Tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo Tablet
Intervention Type
Drug
Intervention Name(s)
AMT-101 (oral)
Intervention Description
AMT 101 is orally administered biological therapeutic taken once daily
Intervention Type
Other
Intervention Name(s)
Placebo (oral)
Intervention Description
Orally administered placebo comparator taken once daily
Primary Outcome Measure Information:
Title
Change in Mayo Score
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Endoscopic Remission Rate
Time Frame
12 weeks
Title
Mucosal Healing Rate
Time Frame
12 weeks
Title
Histologic Remission Rate
Time Frame
12 weeks
Title
Clinical Remission Rate
Time Frame
12 weeks

10. Eligibility

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

12. IPD Sharing Statement

Learn more about this trial

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

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