Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis
NCT ID: NCT05570006
Last Updated: 2025-12-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2023-03-16
2024-12-23
Brief Summary
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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 30 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ABBV-668
Participants will receive ABBV-668 twice daily approximately at same time each day for 16 weeks.
ABBV-668
Oral Capsule
Interventions
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ABBV-668
Oral Capsule
Eligibility Criteria
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Inclusion Criteria
* 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
* Extent of inflammatory disease limited to the rectum as assessed by screening endoscopy.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Gastro SB /ID# 249271
Chula Vista, California, United States
Ctr for Advanced Gastroenterol /ID# 249226
Maitland, Florida, United States
Atlantic Medical Research /ID# 249213
Margate, Florida, United States
Endoscopic Research, Inc. /ID# 249202
Orlando, Florida, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 249278
Macon, Georgia, United States
NYU Langone Long Island Clinical Research Associates /ID# 250075
Lake Success, New York, United States
Columbia University Medical Center /ID# 250189
New York, New York, United States
Lenox Hill Hospital /ID# 250008
New York, New York, United States
Atrium Health /ID# 249273
Charlotte, North Carolina, United States
Options Health Research, LLC /ID# 249216
Tulsa, Oklahoma, United States
University of Pennsylvania /ID# 250012
Philadelphia, Pennsylvania, United States
Allegheny Singer Research Institute d/b/a AHN Research Institute /ID# 250079
Pittsburgh, Pennsylvania, United States
University of Pittsburgh MC /ID# 250071
Pittsburgh, Pennsylvania, United States
Gastroenterology Associates, P.A. of Greenville /ID# 249217
Greenville, South Carolina, United States
Quality Medical Research /ID# 251125
Nashville, Tennessee, United States
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 249208
Garland, Texas, United States
Baylor College of Medicine /ID# 249203
Houston, Texas, United States
Southern Star Research Institute, LLC /ID# 249212
San Antonio, Texas, United States
UZ Gent /ID# 248605
Ghent, Oost-Vlaanderen, Belgium
Vitaz /Id# 248607
Sint-Niklaas, Oost-Vlaanderen, Belgium
Universitair Ziekenhuis Leuven /ID# 248598
Leuven, Vlaams-Brabant, Belgium
Groupe Sante CHC - Clinique du MontLegia /ID# 248928
Liège, , Belgium
CHU Montpellier - Hopital Saint Eloi /ID# 251876
Montpellier, Herault, France
CHU Grenoble - Hopital Michallon /ID# 252108
La Tronche, Isere, France
Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251875
St-Priest-en-Jarez, Pays de la Loire Region, France
Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252357
Neuilly-sur-Seine, Île-de-France Region, France
Gastromed Sp. z o.o /ID# 255664
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Medical Network Sp.z.o.o. WIP Warsaw IBD Point Profesor Kierkus /ID# 255663
Warsaw, Masovian Voivodeship, Poland
Endoskopia Sp. z o.o. /ID# 255667
Sopot, Pomeranian Voivodeship, Poland
H-T Centrum Medyczne Endoterapia /ID# 255666
Tychy, Silesian Voivodeship, Poland
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2022-501263-41-00
Identifier Type: OTHER
Identifier Source: secondary_id
M21-446
Identifier Type: -
Identifier Source: org_study_id