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ABBV-668

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

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 used for?

ABBV-668 is an investigational small molecule being developed for the treatment of moderate to severe ulcerative colitis, a form of inflammatory bowel disease. It is administered as an oral capsule and is currently in clinical development, though it is not yet approved by regulatory authorities.

Who makes ABBV-668?

ABBV-668 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with ulcerative colitis.

What phase is ABBV-668 in?

ABBV-668 is in Phase 2 clinical development. A Phase 2 study has been completed, which assessed adverse events and change in disease activity in adult participants with moderate to severe ulcerative colitis. The drug remains investigational and has not received FDA approval.

What clinical trials is ABBV-668 in?

ABBV-668 has one completed Phase 2 clinical trial registered as NCT05570006. This study evaluated the drug in 30 adult participants with moderate to severe ulcerative colitis across the United States, Belgium, France, and Poland. The trial was not randomized, double-blind, or controlled.

How is ABBV-668 administered?

ABBV-668 is administered as an oral capsule. In the completed Phase 2 study, adult participants with moderate to severe ulcerative colitis took the drug by mouth to assess its effects on disease activity and safety.