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ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis

Primary Purpose

Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ABI-M201
Placebo
Sponsored by
Assembly Biosciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis Chronic Mild focused on measuring Phase 1B, Randomized, Placebo Controlled

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Established diagnosis of UC for at least 3 months prior to screening, with minimum disease extent of 15 cm from the anal verge
  • Mildly to moderately active UC
  • Inadequate response to ongoing treatment with oral mesalamine ≥2.4 g/day for ≥4 weeks from screening visit

Exclusion Criteria:

  • Possible or confirmed diagnosis of Crohn's Disease or other forms of inflammatory bowel disorders
  • Ongoing or failed prior treatment for UC with methotrexate, azathioprine, 6-mercaptopurine, cyclosporine, tofacitinib, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or biologics (e.g., TNF-alpha-antagonists, anti-integrin therapies, or agents targeting IL-12 or IL-23, etc.)
  • Any immunosuppressive condition or treatment with immunosuppressive medications
  • History of prior surgical intervention in any region of the gastrointestinal tract (excluding minor surgery)
  • Prior diagnosis of any cardiovascular, renal, hepatic, endocrine, infectious, hematological, oncologic, neuro-psychiatric or immune-mediated disorder, which in the opinion of the Principal Investigator might impact the subject's safety or compliance, or the interpretation of results
  • Treatment with any other investigational drugs ≤12 weeks prior to baseline visit
  • The participant has a condition or is in a situation which, in the Principal Investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study

Sites / Locations

  • (Investigator site)
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ABI-M201

Placebo

Arm Description

Cohort A: 1 capsule one time a day Cohort B: 1- 5 capsules one time a day

Cohort A: 1 capsule one time a day Cohort B: 1-5 capsules one time a day

Outcomes

Primary Outcome Measures

Incidence of Treatment-Emergent Adverse Events
[Safety]
Incidence of Treatment-Emergent Laboratory Abnormalities
[Safety]

Secondary Outcome Measures

Clinical Remission
[UC Disease Activity]
Endoscopic Improvement
[UC Disease Activity]

Full Information

First Posted
April 15, 2019
Last Updated
March 17, 2021
Sponsor
Assembly Biosciences
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1. Study Identification

Unique Protocol Identification Number
NCT03923478
Brief Title
ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase 1b Study to Evaluate the Safety, Efficacy and Mircobiological Response of Oral ABI-M201 in Subjects With Mildly-to-Moderately Active UC With Ongoing Mesalamine Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor Decision
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
January 20, 2021 (Actual)
Study Completion Date
January 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assembly Biosciences

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
Phase 1B randomized, double-blind, placebo-controlled, two-cohort clinical trial of ABI-M201 in adult subjects with mildly-to-moderately active Ulcerative Colitis(UC) and ongoing treatment with mesalamine.
Detailed Description
This multi-center randomized, double-blind, placebo-controlled study will evaluate the safety of ABI-M201 and its effects on disease activity measures in men and women with mildly-to-moderately active UC and ongoing treatment with mesalamine. The study will consist of 2 sequential, non-overlapping participant cohorts, separated by intervening interim analysis (IA). Both cohorts will involve 8-weeks of study drug treatment. Interim data from the initial treatment cohort (Cohort A) will inform decision to advance to the subsequent second cohort (Cohort B) and its dose selection. 20 subjects will be randomized to cohort A (1:1 allocation) and receive treatment with 1 capsule per day of ABI-M201 versus Placebo. 24 subjects will be randomized to cohort B (3:1 allocation) and receive treatment with up to 5 capsules one time a day of ABI-M201 versus Placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate
Keywords
Phase 1B, Randomized, Placebo Controlled

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Double blind, placebo-controlled trial involving two sequential non-overlapping cohorts, with intervening interim analysis
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABI-M201
Arm Type
Experimental
Arm Description
Cohort A: 1 capsule one time a day Cohort B: 1- 5 capsules one time a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Cohort A: 1 capsule one time a day Cohort B: 1-5 capsules one time a day
Intervention Type
Drug
Intervention Name(s)
ABI-M201
Intervention Description
Active Treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Control Treatment
Primary Outcome Measure Information:
Title
Incidence of Treatment-Emergent Adverse Events
Description
[Safety]
Time Frame
8-weeks
Title
Incidence of Treatment-Emergent Laboratory Abnormalities
Description
[Safety]
Time Frame
8-weeks
Secondary Outcome Measure Information:
Title
Clinical Remission
Description
[UC Disease Activity]
Time Frame
8-weeks
Title
Endoscopic Improvement
Description
[UC Disease Activity]
Time Frame
8-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Established diagnosis of UC for at least 3 months prior to screening, with minimum disease extent of 15 cm from the anal verge Mildly to moderately active UC Inadequate response to ongoing treatment with oral mesalamine ≥2.4 g/day for ≥4 weeks from screening visit Exclusion Criteria: Possible or confirmed diagnosis of Crohn's Disease or other forms of inflammatory bowel disorders Ongoing or failed prior treatment for UC with methotrexate, azathioprine, 6-mercaptopurine, cyclosporine, tofacitinib, mycophenolate mofetil, sirolimus (rapamycin), thalidomide, tacrolimus (FK-506), or biologics (e.g., TNF-alpha-antagonists, anti-integrin therapies, or agents targeting IL-12 or IL-23, etc.) Any immunosuppressive condition or treatment with immunosuppressive medications History of prior surgical intervention in any region of the gastrointestinal tract (excluding minor surgery) Prior diagnosis of any cardiovascular, renal, hepatic, endocrine, infectious, hematological, oncologic, neuro-psychiatric or immune-mediated disorder, which in the opinion of the Principal Investigator might impact the subject's safety or compliance, or the interpretation of results Treatment with any other investigational drugs ≤12 weeks prior to baseline visit The participant has a condition or is in a situation which, in the Principal Investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study
Facility Information:
Facility Name
(Investigator site)
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
(Investigator Site)
City
San Carlos
State/Province
California
ZIP/Postal Code
94070
Country
United States
Facility Name
(Investigator Site)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
(Investigator Site)
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
(Investigator Site)
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
(Investigator Site)
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
(Investigator Site)
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
(Investigator Site)
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
(Investigator Site)
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
(Investigator Site)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
(Investigator site)
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3C 5K6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ABI-M201 in Adult Subjects With Mildly-to-Moderately Active Ulcerative Colitis

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