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)
TERMINATED
PHASE2
7 participants
Baseline and Week 16
2026-05-29
Participant Flow
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
| 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 16Median 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
| 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
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place