NCT03923478

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2019

Geographic Reach
2 countries

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 15, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

June 24, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
Last Updated

March 19, 2021

Status Verified

March 1, 2021

Enrollment Period

1.6 years

First QC Date

April 15, 2019

Last Update Submit

March 17, 2021

Conditions

Ulcerative Colitis Chronic MildUlcerative Colitis Chronic Moderate

Keywords

Phase 1BRandomizedPlacebo Controlled

Outcome Measures

Primary Outcomes (2)

  • Incidence of Treatment-Emergent Adverse Events

    \[Safety\]

    8-weeks

  • Incidence of Treatment-Emergent Laboratory Abnormalities

    \[Safety\]

    8-weeks

Secondary Outcomes (2)

  • Clinical Remission

    8-weeks

  • Endoscopic Improvement

    8-weeks

Study Arms (2)

ABI-M201

EXPERIMENTAL

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

Drug: ABI-M201

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

ABI-M201DRUG

Active Treatment

ABI-M201
PlaceboDRUG

Control Treatment

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

(Investigator site)

Oakland, California, 94612, United States

Location

(Investigator Site)

San Carlos, California, 94070, United States

Location

(Investigator Site)

Decatur, Georgia, 30033, United States

Location

(Investigator Site)

Shreveport, Louisiana, 71105, United States

Location

(Investigator Site)

Chesterfield, Michigan, 48047, United States

Location

(Investigator Site)

Ypsilanti, Michigan, 48197, United States

Location

(Investigator Site)

Rochester, Minnesota, 55905, United States

Location

(Investigator Site)

Jackson, Tennessee, 38305, United States

Location

(Investigator Site)

Bellevue, Washington, 98004, United States

Location

(Investigator Site)

Milwaukee, Wisconsin, 53226, United States

Location

(Investigator site)

Greater Sudbury, Ontario, P3C 5K6, Canada

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Double blind, placebo-controlled trial involving two sequential non-overlapping cohorts, with intervening interim analysis
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2019

First Posted

April 22, 2019

Study Start

June 24, 2019

Primary Completion

January 20, 2021

Study Completion

January 20, 2021

Last Updated

March 19, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(10)CA(1)