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Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ABBV-668
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Ulcerative Colitis, ABBV-668

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of ulcerative colitis (UC) for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available.
  • Participant meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review).
  • Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunosuppressants and/or biologics or targeted immunomodulators.

Exclusion Criteria:

  • Current diagnosis of crohn's disease (CD) or inflammatory bowel disease-unclassified (IBD-U).
  • Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.

Sites / Locations

  • Gastro SB /ID# 249271Recruiting
  • Ctr for Advanced Gastroenterol /ID# 249226Recruiting
  • Atlantic Medical Research /ID# 249213Recruiting
  • Endoscopic Research, Inc. /ID# 249202Recruiting
  • Gastroenterology Associates of Central Georgia, LLC /ID# 249278Recruiting
  • NYU Langone Long Island Clinical Research Associates /ID# 250075Recruiting
  • Columbia University Medical Center /ID# 250189Recruiting
  • Lenox Hill Hospital /ID# 250008Recruiting
  • Atrium Health /ID# 249273Recruiting
  • Options Health Research, LLC /ID# 249216Recruiting
  • University of Pennsylvania /ID# 250012Recruiting
  • University of Pittsburgh MC /ID# 250071Recruiting
  • Gastroenterology Associates, P.A. of Greenville /ID# 249217Recruiting
  • Quality Medical Research /ID# 251125Recruiting
  • DHAT Research Institute /ID# 249208Recruiting
  • Southern Star Research Institute, LLC /ID# 249212Recruiting
  • UZ Gent /ID# 248605Recruiting
  • Universitair Ziekenhuis Leuven /ID# 248598Recruiting
  • Groupe Sante CHC - Clinique du MontLegia /ID# 248928Recruiting
  • Vitaz /Id# 248607Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ABBV-668

Arm Description

Participants will receive ABBV-668 twice daily approximately at same time each day for 16 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Endoscopic Improvement
Endoscopic Improvement is defined as Mayo Endoscopic Subscore (ESS) of 0 or 1. The Endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration).

Secondary Outcome Measures

Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score
Clinical Remission per Adapted Mayo Score is defined as stool frequency subscore (SFS) ≤ 1, and not greater than baseline, rectal bleeding subscore (RBS) = 0, and endoscopic subscore (ESS) ≤ 1.The adapted Mayo Score is a composite of the following subscores: Stool Frequency subscore, Rectal Bleeding subscore and Endoscopy subscore.
Percentage of Participants Achieving Clinical Response per Adapted Mayo Score
Clinical response per Adapted Mayo Score is defined as decrease from baseline ≥ 2 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. The adapted Mayo Score is a composite of the following subscores: Stool Frequency subscore, Rectal Bleeding subscore and Endoscopy subscore.
Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo score
Clinical response per Partial Adapted Mayo Score is defined as decrease from baseline ≥ 1 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. The Partial Adapted Mayo Score is a composite of the following subscores: Stool Frequency subscore and Rectal Bleeding subscore.
Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) = 0. The Endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration).

Full Information

First Posted
October 5, 2022
Last Updated
October 17, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05570006
Brief Title
Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis
Official Title
A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABBV-668 in Subjects With Moderate to Severe Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
May 31, 2025 (Anticipated)
Study Completion Date
August 25, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how safe and effective ABBV-668 is in treating adult participants with UC. Adverse events and change in disease activity will be assessed. ABBV-668 is an investigational drug being developed for the treatment of moderate to severe UC. Approximately 40 adult participants diagnosed with UC will be enrolled in approximately 23 sites globally. Participants will receive oral capsules of ABBV-668 twice daily for 16-weeks and will undergo a 30 day follow-up period. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Ulcerative Colitis, ABBV-668

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ABBV-668
Arm Type
Experimental
Arm Description
Participants will receive ABBV-668 twice daily approximately at same time each day for 16 weeks.
Intervention Type
Drug
Intervention Name(s)
ABBV-668
Intervention Description
Oral Capsule
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Endoscopic Improvement
Description
Endoscopic Improvement is defined as Mayo Endoscopic Subscore (ESS) of 0 or 1. The Endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration).
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score
Description
Clinical Remission per Adapted Mayo Score is defined as stool frequency subscore (SFS) ≤ 1, and not greater than baseline, rectal bleeding subscore (RBS) = 0, and endoscopic subscore (ESS) ≤ 1.The adapted Mayo Score is a composite of the following subscores: Stool Frequency subscore, Rectal Bleeding subscore and Endoscopy subscore.
Time Frame
Week 8
Title
Percentage of Participants Achieving Clinical Response per Adapted Mayo Score
Description
Clinical response per Adapted Mayo Score is defined as decrease from baseline ≥ 2 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. The adapted Mayo Score is a composite of the following subscores: Stool Frequency subscore, Rectal Bleeding subscore and Endoscopy subscore.
Time Frame
Week 8
Title
Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo score
Description
Clinical response per Partial Adapted Mayo Score is defined as decrease from baseline ≥ 1 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. The Partial Adapted Mayo Score is a composite of the following subscores: Stool Frequency subscore and Rectal Bleeding subscore.
Time Frame
Week 8
Title
Percentage of Participants Achieving Endoscopic Remission
Description
Endoscopic remission is defined as Mayo Endoscopic Subscore (ESS) = 0. The Endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration).
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of ulcerative colitis (UC) for at least 90 days prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC in the assessment of the Investigator, must be available. Participant meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review). Demonstrated inadequate response to, loss of response to, or intolerance to at least one of the following: oral aminosalicylates, corticosteroids, immunosuppressants and/or targeted immunomodulators (including biologics and non-biologics) Exclusion Criteria: Current diagnosis of crohn's disease (CD) or inflammatory bowel disease-unclassified (IBD-U). Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Gastro SB /ID# 249271
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910-5619
Country
United States
Individual Site Status
Recruiting
Facility Name
Ctr for Advanced Gastroenterol /ID# 249226
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751-6108
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlantic Medical Research /ID# 249213
City
Margate
State/Province
Florida
ZIP/Postal Code
33063-5737
Country
United States
Individual Site Status
Recruiting
Facility Name
Endoscopic Research, Inc. /ID# 249202
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastroenterology Associates of Central Georgia, LLC /ID# 249278
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Long Island Clinical Research Associates /ID# 250075
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Name
Columbia University Medical Center /ID# 250189
City
New York
State/Province
New York
ZIP/Postal Code
10032-3729
Country
United States
Individual Site Status
Recruiting
Facility Name
Lenox Hill Hospital /ID# 250008
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Individual Site Status
Recruiting
Facility Name
Atrium Health /ID# 249273
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204-2963
Country
United States
Individual Site Status
Recruiting
Facility Name
Options Health Research, LLC /ID# 249216
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pennsylvania /ID# 250012
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5502
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Pittsburgh MC /ID# 250071
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Individual Site Status
Recruiting
Facility Name
Gastroenterology Associates, P.A. of Greenville /ID# 249217
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Individual Site Status
Recruiting
Facility Name
Quality Medical Research /ID# 251125
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
615.832.5530
Facility Name
DHAT Research Institute /ID# 249208
City
Garland
State/Province
Texas
ZIP/Postal Code
75044-2208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
817-345-7463
Facility Name
Southern Star Research Institute, LLC /ID# 249212
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-5390
Country
United States
Individual Site Status
Recruiting
Facility Name
UZ Gent /ID# 248605
City
Gent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Leuven /ID# 248598
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Groupe Sante CHC - Clinique du MontLegia /ID# 248928
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Vitaz /Id# 248607
City
Sint-Niklaas
ZIP/Postal Code
9100
Country
Belgium
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
IPD Sharing Time Frame
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
IPD Sharing Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
https://www.abbvieclinicaltrials.com/study/?id=M21-446
Description
Related Info

Learn more about this trial

Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis

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