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ABBV-668

Phase 2

Ulcerative Colitis | Small molecule | Gastrointestinal |AbbVie Inc.|Trials Updated: Dec 23, 2025

ABBV-668 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Oct 2022

ABBV-668 target and mechanism

ModalitySmall molecule

Also known as ABBV-668 ER

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

ABBV-668 clinical trials

ABBV-668 · 1 trial · 1 indication

Phase 2 1
NCT05570006Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative ColitisUlcerative Colitis
COMPLETED30 Analytics
PHASE2COMPLETED
Study of ABBV-668 Oral Capsules to Assess Adverse Events and Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis
Ulcerative ColitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants Achieving Endoscopic Improvement
Week 8

Endoscopic improvement was defined as Mayo endoscopic subscore of 0 or 1. The endoscopic subscore is scored from 0 (Normal appearance mucosa) to 3 (severe disease, spontaneous bleeding, ulceration) with lower scores associated with better health outcomes.

Number of Participants With Adverse Events (AEs)
From the time of first study drug administration until 30 days after the last dose of study drug (Up to approximately 20 weeks)

An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

Secondary Endpoints

Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score
Baseline, Week 8
Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score
Baseline, Week 8
Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score
Baseline, Week 8
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

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

Interventions

NameTypeDescription
ABBV-668DRUGOral Capsule
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites30

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: A...

Countries:United StatesBelgiumFrancePoland
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Frequently asked questions about ABBV-668

What is ABBV-668?

ABBV-668 is an investigational oral small molecule developed by AbbVie Inc. for ulcerative colitis. It is also known as ABBV-668 ER. The drug has been studied in a Phase 2 clinical trial in adults with moderate to severe ulcerative colitis, and it has not been approved by the FDA.

What is ABBV-668 used for?

ABBV-668 is being studied for the treatment of moderate to severe ulcerative colitis, a gastrointestinal inflammatory condition. The Phase 2 trial enrolled adults 18 years and older with this condition. ABBV-668 is investigational and has not been approved for any indication.

Who makes ABBV-668?

ABBV-668 is developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program evaluating the drug in ulcerative colitis.

What phase is ABBV-668 in?

ABBV-668 is in Phase 2 development. A single Phase 2 trial in moderate to severe ulcerative colitis has been completed, and no active trials are currently listed. The drug remains investigational and has not received FDA approval.

What clinical trials is ABBV-668 in?

ABBV-668 has been evaluated in one completed Phase 2 trial, NCT05570006, titled a study of ABBV-668 oral capsules to assess adverse events and change in disease activity in adult participants with moderate to severe ulcerative colitis. The trial enrolled 30 participants across the United States, Belgium, France, and Poland.

Is ABBV-668 the same as ABBV-668 ER?

Yes, ABBV-668 ER is an alternative name for ABBV-668. Both names refer to the same investigational oral small molecule developed by AbbVie Inc. for moderate to severe ulcerative colitis, so searches for either name refer to the same drug asset.