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

Primary Purpose

Ulcerative Colitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AMT-101 (oral)

Placebo (oral)

Humira (adalimumab)

About this trial

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

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male and female subjects aged 18 to 75 years.
Moderate to severe UC.
Eligible for Humira (adalimumab) therapy.
Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit.
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

Arensia Exploratory Medicine GmbH Georgia
Academic Medical Center
NZOZ Vitamed
Centrum Medyczne LukaMed Joanna Łuka-Wendrowska
Centrum Medyczne CLW-med Aneta Cichomska , Joanna Łuka -Wendrowska
Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla
Centrum Innowacyjnych Terapii Sp. z o.o. Oddzial w Piasecznie
Centrum Medyczne Medyk
H.T. Centrum Medyczne - Endoterapia
Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz
Bodyclinic sp z o.o. Sp. Kom.
Centrum Medyczne Melita Medical
Medical Center of Limited Liability Company "Harmoniya Krasy"
Medical Center "OK!Clinic+" of International Institute of Clinical Research LLC, Gastroenterology and Hepatology unit of Hospital department
Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Hospital", Therapeutic Department
Municipal non-profit enterprise "Vinnytsia Regional Clinical Hospital named after M.I. Pirogov of Vinnytsia Regional Council", Regional Specialized Clinical gastroenterological Center
Municipal non-profit enterprise "Vinnytsya City Clinical Hospital No1", Gastroenterology Department
Medical Center of Limited Liability Company "Medibor", Department of Daycare, Day Surgery with Intensive Care Ward

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

AMT-101 and Humira (adalimumab)

Placebo and Humira (adalimumab)

Arm Description

AMT-101 Tablet

Placebo Tablet

Outcomes

Primary Outcome Measures

Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline

To evaluate the effects of AMT-101 in combination with adalimumab on ulcerative colitis (UC) disease activity

Secondary Outcome Measures

Mean change in Robarts Histopathology Index (RHI) from baseline

Mean change in total Mayo Clinic Score (MCS) and component scores (Mayo Endoscopic Subscore [MES], partial MCS, rectal bleeding and stool frequency) from baseline

Mean change in fecal calprotectin from baseline

Mean change in high-sensitivity C-reactive protein (hs-CRP) from baseline

Proportion of subjects who achieve a significant reduction in RHI

Clinical remission rate

Clinical response rate

Full Information

NCT ID

NCT05372939

First Posted

September 22, 2021

Last Updated

September 13, 2022

Sponsor

Applied Molecular Transport

1. Study Identification

Unique Protocol Identification Number

NCT05372939

Brief Title

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

Official Title

A Randomized, Placebo-controlled, Double-blind, Parallel-group, Exploratory, Phase 2 Study of the Efficacy and Safety of Oral AMT-101 in Combination With Adalimumab in Subjects With Moderate to Severe Ulcerative Colitis

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Completed

Study Start Date

February 5, 2021 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

July 13, 2022 (Actual)

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

Data Monitoring Committee

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 Combination With Adalimumab 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 Combination with Adalimumab 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

51 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMT-101 and Humira (adalimumab)

Arm Type

Active Comparator

Arm Description

AMT-101 Tablet

Arm Title

Placebo and Humira (adalimumab)

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

Intervention Type

Combination Product

Intervention Name(s)

Humira (adalimumab)

Intervention Description

Humira comparator is administered subcutaneously, on Humira frequency schedule.

Primary Outcome Measure Information:

Title

Ulcerative Colitis disease activity as assessed by mean change in UC-100 Score from baseline

Description

To evaluate the effects of AMT-101 in combination with adalimumab on ulcerative colitis (UC) disease activity

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Mean change in Robarts Histopathology Index (RHI) from baseline

Time Frame

8 weeks

Title

Mean change in total Mayo Clinic Score (MCS) and component scores (Mayo Endoscopic Subscore [MES], partial MCS, rectal bleeding and stool frequency) from baseline

Time Frame

8 weeks

Title

Mean change in fecal calprotectin from baseline

Time Frame

8 weeks

Title

Mean change in high-sensitivity C-reactive protein (hs-CRP) from baseline

Time Frame

8 weeks

Title

Proportion of subjects who achieve a significant reduction in RHI

Time Frame

8 weeks

Title

Clinical remission rate

Time Frame

8 weeks

Title

Clinical response rate

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male and female subjects aged 18 to 75 years. Moderate to severe UC. Eligible for Humira (adalimumab) therapy. Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and at the randomization visit. 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

Arensia Exploratory Medicine GmbH Georgia

City

Tbilisi

ZIP/Postal Code

0112

Country

Georgia

Facility Name

Academic Medical Center

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

NZOZ Vitamed

City

Bydgoszcz

ZIP/Postal Code

85-079

Country

Poland

Facility Name

Centrum Medyczne LukaMed Joanna Łuka-Wendrowska

City

Chojnice

ZIP/Postal Code

89-600

Country

Poland

Facility Name

Centrum Medyczne CLW-med Aneta Cichomska , Joanna Łuka -Wendrowska

City

Grudziądz

ZIP/Postal Code

86-300

Country

Poland

Facility Name

Indywidualna Specjalistyczna Praktyka Lekarska Maciej Zymla

City

Knurów

ZIP/Postal Code

44-190

Country

Poland

Facility Name

Centrum Innowacyjnych Terapii Sp. z o.o. Oddzial w Piasecznie

City

Piaseczno

ZIP/Postal Code

05-500

Country

Poland

Facility Name

Centrum Medyczne Medyk

City

Rzeszów

ZIP/Postal Code

35-326

Country

Poland

Facility Name

H.T. Centrum Medyczne - Endoterapia

City

Tychy

ZIP/Postal Code

43-100

Country

Poland

Facility Name

Niepubliczny Zakład Opieki Zdrowotnej Vivamed Jadwiga Miecz

City

Warszawa

ZIP/Postal Code

03-580

Country

Poland

Facility Name

Bodyclinic sp z o.o. Sp. Kom.

City

Warszawa

ZIP/Postal Code

03-712

Country

Poland

Facility Name

Centrum Medyczne Melita Medical

City

Wrocław

ZIP/Postal Code

50-449

Country

Poland

Facility Name

Medical Center of Limited Liability Company "Harmoniya Krasy"

City

Kyiv

ZIP/Postal Code

01135

Country

Ukraine

Facility Name

Medical Center "OK!Clinic+" of International Institute of Clinical Research LLC, Gastroenterology and Hepatology unit of Hospital department

City

Kyiv

ZIP/Postal Code

02091

Country

Ukraine

Facility Name

Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Hospital", Therapeutic Department

City

Kyiv

ZIP/Postal Code

04078

Country

Ukraine

Facility Name

Municipal non-profit enterprise "Vinnytsia Regional Clinical Hospital named after M.I. Pirogov of Vinnytsia Regional Council", Regional Specialized Clinical gastroenterological Center

City

Vinnytsia

ZIP/Postal Code

21028

Country

Ukraine

Facility Name

Municipal non-profit enterprise "Vinnytsya City Clinical Hospital No1", Gastroenterology Department

City

Vinnytsia

ZIP/Postal Code

21029

Country

Ukraine

Facility Name

Medical Center of Limited Liability Company "Medibor", Department of Daycare, Day Surgery with Intensive Care Ward

City

Zhytomyr

ZIP/Postal Code

10003

Country

Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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