Trial Outcomes & Findings for 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 NCT05570006)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Week 8

Results posted on

2025-12-23

Participant Flow

Participant milestones

Participant milestones
Measure	ABBV-668 Participants received ABBV-668 twice daily for 16 weeks.
Overall Study STARTED	30
Overall Study Received at Least 1 Dose of Study Drug	30
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	ABBV-668 Participants received ABBV-668 twice daily for 16 weeks.
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	5
Overall Study Other than Specified	5

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ABBV-668 n=30 Participants Participants received ABBV-668 twice daily for 16 weeks.
Age, Continuous	39.3 years STANDARD_DEVIATION 13.40 • n=68 Participants
Sex: Female, Male Female	11 Participants n=68 Participants
Sex: Female, Male Male	19 Participants n=68 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=68 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	28 Participants n=68 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=68 Participants
Race (NIH/OMB) Asian	2 Participants n=68 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=68 Participants
Race (NIH/OMB) Black or African American	1 Participants n=68 Participants
Race (NIH/OMB) White	27 Participants n=68 Participants
Race (NIH/OMB) More than one race	0 Participants n=68 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=68 Participants

PRIMARY outcome

Timeframe: Week 8

Population: The ITT Population consisted of all participants who received at least 1 dose of study drug.

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.

Outcome measures

Outcome measures
Measure	ABBV-668 n=30 Participants Participants received ABBV-668 twice daily for 16 weeks.
Percentage of Participants Achieving Endoscopic Improvement	16.7 percentage of participants Interval 3.3 to 30.0

PRIMARY outcome

Timeframe: From the time of first study drug administration until 30 days after the last dose of study drug (Up to approximately 20 weeks)

Population: The Safety Population consisted of all participants who received at least 1 dose of study drug.

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

Outcome measures

Outcome measures
Measure	ABBV-668 n=30 Participants Participants received ABBV-668 twice daily for 16 weeks.
Number of Participants With Adverse Events (AEs)	23 Participants

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: The ITT Population consisted of all participants who received at least 1 dose of study drug.

The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: * Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). * Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). * Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical remission per Adapted Mayo Score was defined as SFS ≤ 1 and not higher than Baseline, RBS of 0, and endoscopic subscore ≤ 1. Data are reported for the percentage of participants achieving clinical remission per adapted Mayo score.

Outcome measures

Outcome measures
Measure	ABBV-668 n=30 Participants Participants received ABBV-668 twice daily for 16 weeks.
Percentage of Participants Achieving Clinical Remission Per Adapted Mayo Score	6.7 percentage of participants Interval 0.0 to 15.6

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: The ITT Population consisted of all participants who received at least 1 dose of study drug.

The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). The overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response per Adapted Mayo Score was defined as a decrease from baseline in the overall score of ≥ 2 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. Data are reported for the percentage of participants achieving clinical response per adapted Mayo score.

Outcome measures

Outcome measures
Measure	ABBV-668 n=30 Participants Participants received ABBV-668 twice daily for 16 weeks.
Percentage of Participants Achieving Clinical Response Per Adapted Mayo Score	33.3 percentage of participants Interval 16.5 to 50.2

SECONDARY outcome

Timeframe: Baseline, Week 8

Population: The ITT Population consisted of all participants who received at least 1 dose of study drug.

The Partial Adapted Mayo Score is a composite score of UC disease activity based on the following 2 subscores: Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal). Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed). The overall Partial Adapted Mayo score ranges from 0 to 6 where higher scores represent more severe disease. Clinical response per Partial Adapted Mayo Score was defined as a decrease from baseline in the overall score of ≥ 1 points and ≥ 30%, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1. Data are reported for the percentage of participants achieving clinical response per partial adapted Mayo score.

Outcome measures

Outcome measures
Measure	ABBV-668 n=30 Participants Participants received ABBV-668 twice daily for 16 weeks.
Percentage of Participants Achieving Clinical Response Per Partial Adapted Mayo Score	40.0 percentage of participants Interval 22.5 to 57.5

SECONDARY outcome

Timeframe: Week 8

Population: The ITT Population consisted of all participants who received at least 1 dose of study drug.

Endoscopic remission was defined as Mayo endoscopic subscore of 0. 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.

Outcome measures

Outcome measures
Measure	ABBV-668 n=30 Participants Participants received ABBV-668 twice daily for 16 weeks.
Percentage of Participants Achieving Endoscopic Remission	6.7 percentage of participants Interval 0.0 to 15.6

Adverse Events

ABBV-668

Serious events: 4 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ABBV-668 n=30 participants at risk Participants received ABBV-668 twice daily for 16 weeks.
Blood and lymphatic system disorders ANAEMIA	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 144.0 Days. All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ANOGENITAL DYSPLASIA	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 144.0 Days. All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
Gastrointestinal disorders COLITIS ULCERATIVE	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 144.0 Days. All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
Gastrointestinal disorders ILEUS	3.3% 1/30 • Number of events 1 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 144.0 Days. All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
Renal and urinary disorders URINARY RETENTION	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 144.0 Days. All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.

Other adverse events

Other adverse events
Measure	ABBV-668 n=30 participants at risk Participants received ABBV-668 twice daily for 16 weeks.
Gastrointestinal disorders COLITIS ULCERATIVE	20.0% 6/30 • Number of events 6 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 144.0 Days. All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
Gastrointestinal disorders NAUSEA	13.3% 4/30 • Number of events 4 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 144.0 Days. All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
General disorders ASTHENIA	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 144.0 Days. All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	10.0% 3/30 • Number of events 3 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 144.0 Days. All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
Musculoskeletal and connective tissue disorders ARTHRALGIA	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 144.0 Days. All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
Nervous system disorders HEADACHE	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 144.0 Days. All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.
Skin and subcutaneous tissue disorders NIGHT SWEATS	6.7% 2/30 • Number of events 2 • All-cause mortality and adverse event tables include events reported from the start of safety data collection to the end of the study. The median time on follow-up was 144.0 Days. All-cause mortality and adverse events: all participants who received at least 1 dose of study drug.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
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