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NCT05570006CompletedPhase 2

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

A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of ABBV-668 in Subjects With Moderate to Severe Ulcerative Colitis

Source: ClinicalTrials.gov · Last updated 23 Dec 2025

Brief summary (registry, in English)

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 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.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
30 (actual)
First submitted
5 Oct 2022
Start date
16 Mar 2023
Primary completion date
23 Dec 2024
Lead sponsor
AbbVie
NCT number
NCT05570006
EU CT number
2022-501263-41-00

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 30
  • From 16 Mar 2023 to the primary completion date, 23 Dec 2024
  • 30 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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.

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (30)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis Gent
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GentBelgiumCompleted
UZ Leuven
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LeuvenBelgiumCompleted
CHC
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LiegeBelgiumCompleted
Verenigde Ziekenhuizen van Waas en Durme
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Sint-NiklaasBelgiumCompleted
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceCompleted
Hopital Saint Eloi
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Montpellier Cedex 5FranceCompleted
Centre Medico Chirurgical Ambroise Pare Hartmann
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Neuilly-Sur-SeineFranceCompleted
Centre Hospitalier Universitaire de Saint Etienne
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Saint-Priest-en-JarezFranceCompleted
Endoskopia Sp z o.o.
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SopotPolandCompleted
GASTROMED Sp. z o.o.
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TorunPolandCompleted
H-T.Centrum Medyczne Sp. z o.o.
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TychyPolandCompleted
WIP Warsaw IBD Point
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WarszawaPolandCompleted
Atrium Health /ID# 249273
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CharlotteUnited StatesUnknown status
Gastro SB /ID# 249271
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Chula VistaUnited StatesUnknown status
Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 249208
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GarlandUnited StatesUnknown status
Gastroenterology Associates, P.A. of Greenville /ID# 249217
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GreenvilleUnited StatesUnknown status
Baylor College of Medicine /ID# 249203
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HoustonUnited StatesUnknown status
NYU Langone Long Island Clinical Research Associates /ID# 250075
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Lake SuccessUnited StatesUnknown status
Gastroenterology Associates of Central Georgia, LLC /ID# 249278
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MaconUnited StatesUnknown status
Ctr for Advanced Gastroenterol /ID# 249226
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MaitlandUnited StatesUnknown status
Atlantic Medical Research /ID# 249213
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MargateUnited StatesUnknown status
Quality Medical Research /ID# 251125
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NashvilleUnited StatesUnknown status
Lenox Hill Hospital /ID# 250008
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New YorkUnited StatesUnknown status
Columbia University Medical Center /ID# 250189
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New YorkUnited StatesUnknown status
Endoscopic Research, Inc. /ID# 249202
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OrlandoUnited StatesUnknown status
University of Pennsylvania /ID# 250012
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PhiladelphiaUnited StatesUnknown status
University of Pittsburgh MC /ID# 250071
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PittsburghUnited StatesUnknown status
Allegheny Singer Research Institute d/b/a AHN Research Institute /ID# 250079
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PittsburghUnited StatesUnknown status
Southern Star Research Institute, LLC /ID# 249212
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San AntonioUnited StatesUnknown status
Options Health Research, LLC /ID# 249216
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TulsaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.