Clinical trial NCT05570006: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: Ulcerative Colitis
ABBV-668
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 30 sites globally.

Participants will receive oral capsules of ABBV-668 twice daily for 52-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.


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.

Primary outcomes:
measure: Percentage of Participants Achieving Endoscopic Improvement
timeFrame: Week 8
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 56 weeks
Secondary outcomes:
measure: Percentage of Participants Achieving Clinical Remission per Adapted Mayo Score
timeFrame: Week 8
measure: Percentage of Participants Achieving Clinical Response per Adapted Mayo Score
timeFrame: Week 8
measure: Percentage of Participants Achieving Clinical Response per Partial Adapted Mayo score
timeFrame: Week 8
measure: Percentage of Participants Achieving Endoscopic Remission
timeFrame: Week 8
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Gastro SB /ID# 249271
state: California
city: Maitland
country: United States
facility: Ctr for Advanced Gastroenterol /ID# 249226
state: Florida
city: Margate
country: United States
facility: Atlantic Medical Research /ID# 249213
state: Florida
city: Orlando
country: United States
facility: Endoscopic Research, Inc. /ID# 249202
state: Florida
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC /ID# 249278
state: Georgia
city: Lake Success
country: United States
facility: NYU Langone Long Island Clinical Research Associates /ID# 250075
state: New York
city: New York
country: United States
facility: Columbia University Medical Center /ID# 250189
state: New York
city: New York
country: United States
facility: Lenox Hill Hospital /ID# 250008
state: New York
city: Charlotte
country: United States
facility: Atrium Health /ID# 249273
state: North Carolina
city: Tulsa
country: United States
facility: Options Health Research, LLC /ID# 249216
state: Oklahoma
city: Philadelphia
country: United States
facility: University of Pennsylvania /ID# 250012
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny Singer Research Institute d/b/a AHN Research Institute /ID# 250079
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh MC /ID# 250071
state: Pennsylvania
city: Greenville
country: United States
facility: Gastroenterology Associates, P.A. of Greenville /ID# 249217
state: South Carolina
city: Nashville
country: United States
facility: Quality Medical Research /ID# 251125
state: Tennessee
city: Garland
country: United States
facility: Digestive Health Associates of Texas (DHAT) Research Institute - Garland /ID# 249208
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine /ID# 249203
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC /ID# 249212
state: Texas
city: Gent
country: Belgium
facility: UZ Gent /ID# 248605
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: Vitaz /Id# 248607
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven /ID# 248598
state: Vlaams-Brabant
city: Liege
country: Belgium
facility: Groupe Sante CHC - Clinique du MontLegia /ID# 248928
city: Montpellier Cedex 5
country: France
facility: CHU Montpellier - Hopital Saint Eloi /ID# 251876
state: Herault
city: Neuilly Sur Seine
country: France
facility: Centre Medico Chirurgical Ambroise Pare Hartmann /ID# 252357
state: Ile-de-France
city: La Tronche
country: France
facility: CHU Grenoble - Hopital Michallon /ID# 252108
state: Isere
city: St-Priest-en-Jarez
country: France
facility: Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord /ID# 251875
state: Loire
city: Torun
country: Poland
facility: Gastromed Sp. z o.o /ID# 255664
state: Kujawsko-pomorskie
city: Warsaw
country: Poland
facility: Medical Network Sp.z.o.o. WIP Warsaw IBD Point Profesor Kierkus /ID# 255663
state: Mazowieckie
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o. /ID# 255667
state: Pomorskie
city: Tychy
country: Poland
facility: H-T Centrum Medyczne Endoterapia /ID# 255666
state: Slaskie
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: