Trial Outcomes & Findings for Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS). (NCT NCT05997277)

NCT ID: NCT05997277

Last Updated: 2026-05-29

Results Overview

Median change in number of inflammatory lesion count per subject following 16 weeks of treatment as compared to baseline. Inflammatory lesions are defined as inflammatory nodules or abscesses. Increase is interpreted as an additional single standard unit of the disease compared to baseline (1 nodule or abscess = 1 unit)

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

Baseline and Week 16

Results posted on

2026-05-29

Participant Flow

Participant milestones

Participant milestones
Measure
Deucravacitinib - Study Drug
Deucravacitinib group: 6 mg po bid x 16 weeks Deucravacitinib: Deucravacitinib is a stable deuterium-containing compound (where deuterium is a stable, nonradioactive isotope of hydrogen) and a potent, highly selective small molecule inhibitor of TYK2. Deucravacitinib has a unique mode of binding that provides the high selectivity over the other members of the JAK family of nonreceptor tyrosine kinases. 1 active oral tablet (6mg) in the morning and evening for 16weeks.
Placebo
Placebo group: 1 tablet po bid x 16 weeks Placebo: Placebo will consist of a tablet (0mg) and will be administered orally BID for 16weeks.
Overall Study
STARTED
5
2
Overall Study
COMPLETED
3
2
Overall Study
NOT COMPLETED
2
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluating the Safety and Efficacy of Deucravacitinib Compared to Placebo Hidradenitis Suppurativa (HS).

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Deucravacitinib - Study Drug
n=5 Participants
Deucravacitinib group: 6 mg po bid x 16 weeks Deucravacitinib: Deucravacitinib is a stable deuterium-containing compound (where deuterium is a stable, nonradioactive isotope of hydrogen) and a potent, highly selective small molecule inhibitor of TYK2. Deucravacitinib has a unique mode of binding that provides the high selectivity over the other members of the JAK family of nonreceptor tyrosine kinases. 1 active oral tablet (6mg) in the morning and evening for 16weeks.
Placebo
n=2 Participants
Placebo group: 1 tablet po bid x 16 weeks Placebo: Placebo will consist of a tablet (0mg) and will be administered orally BID for 16weeks.
Total
n=7 Participants
Total of all reporting groups
Age, Continuous
35.2 years
STANDARD_DEVIATION 9.6 • n=51 Participants
47 years
STANDARD_DEVIATION 25.5 • n=14 Participants
38.6 years
STANDARD_DEVIATION 14.2 • n=65 Participants
Sex: Female, Male
Female
2 Participants
n=51 Participants
1 Participants
n=14 Participants
3 Participants
n=65 Participants
Sex: Female, Male
Male
3 Participants
n=51 Participants
1 Participants
n=14 Participants
4 Participants
n=65 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
n=51 Participants
2 Participants
n=14 Participants
6 Participants
n=65 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
1 Participants
n=51 Participants
0 Participants
n=14 Participants
1 Participants
n=65 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=51 Participants
0 Participants
n=14 Participants
0 Participants
n=65 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=51 Participants
0 Participants
n=14 Participants
0 Participants
n=65 Participants
Race (NIH/OMB)
Asian
0 Participants
n=51 Participants
0 Participants
n=14 Participants
0 Participants
n=65 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=51 Participants
0 Participants
n=14 Participants
0 Participants
n=65 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=51 Participants
0 Participants
n=14 Participants
2 Participants
n=65 Participants
Race (NIH/OMB)
White
2 Participants
n=51 Participants
2 Participants
n=14 Participants
4 Participants
n=65 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=51 Participants
0 Participants
n=14 Participants
1 Participants
n=65 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=51 Participants
0 Participants
n=14 Participants
0 Participants
n=65 Participants
Region of Enrollment
United States
5 participants
n=51 Participants
2 participants
n=14 Participants
7 participants
n=65 Participants

PRIMARY outcome

Timeframe: Baseline and Week 16

Median change in number of inflammatory lesion count per subject following 16 weeks of treatment as compared to baseline. Inflammatory lesions are defined as inflammatory nodules or abscesses. Increase is interpreted as an additional single standard unit of the disease compared to baseline (1 nodule or abscess = 1 unit)

Outcome measures

Outcome measures
Measure
Deucravacitinib - Study Drug
n=5 Participants
Deucravacitinib group: 6 mg po bid x 16 weeks Deucravacitinib: Deucravacitinib is a stable deuterium-containing compound (where deuterium is a stable, nonradioactive isotope of hydrogen) and a potent, highly selective small molecule inhibitor of TYK2. Deucravacitinib has a unique mode of binding that provides the high selectivity over the other members of the JAK family of nonreceptor tyrosine kinases. 1 active oral tablet (6mg) in the morning and evening for 16weeks.
Placebo
n=2 Participants
Placebo group: 1 tablet po bid x 16 weeks Placebo: Placebo will consist of a tablet (0mg) and will be administered orally BID for 16weeks.
Median Change From Baseline in Number of Inflammatory Lesion Counts (Including Combined Counts of Inflammatory Nodules (N) and Abscesses (A)/AN Count) at Week 16.
-2.0 Inflammatory Lesions
Interval -4.0 to -2.0
-9 Inflammatory Lesions
Interval -14.0 to -4.0

Adverse Events

Deucravacitinib - Study Drug

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Martina Porter

Beth Israel Deaconess Medical Center

Phone: 6176675834

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place