Trial Outcomes & Findings for Topical Ruxolitinib 1.5% for Hidradenitis Suppurativa Treatment (NCT NCT04414514)
NCT ID: NCT04414514
Last Updated: 2026-04-28
Results Overview
The HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (AN count) for all study body sites with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
16 weeks after treatment.
Results posted on
2026-04-28
Participant Flow
Participant milestones
| Measure |
Open-label
Topical Ruxolitinib 1.5% Cream, twice daily for 16 weeks
Ruxolitinib 1.5% Cream: Topical Ruxolitinib 1.5% Cream
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Topical Ruxolitinib 1.5% for Hidradenitis Suppurativa Treatment
Baseline characteristics by cohort
| Measure |
Open-label
n=6 Participants
Topical Ruxolitinib 1.5% Cream, twice daily for 16 weeks
Ruxolitinib 1.5% Cream: Topical Ruxolitinib 1.5% Cream
|
|---|---|
|
Age, Continuous
|
33.2 years
STANDARD_DEVIATION 7.0 • n=9 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 16 weeks after treatment.The HiSCR is defined as at least a 50% reduction in the total abscess and inflammatory nodule count (AN count) for all study body sites with no increase in abscess count and no increase in draining fistula count relative to Baseline.
Outcome measures
| Measure |
Open-label
n=6 Participants
Topical Ruxolitinib 1.5% Cream, twice daily for 16 weeks
Ruxolitinib 1.5% Cream: Topical Ruxolitinib 1.5% Cream
|
|---|---|
|
Number of Participants With Hidradenitis Suppurativa Clinical Response (HiSCR)
|
5 Participants
|
Adverse Events
Open-label
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Open-label
n=6 participants at risk
Topical Ruxolitinib 1.5% Cream, twice daily for 16 weeks
Ruxolitinib 1.5% Cream: Topical Ruxolitinib 1.5% Cream
|
|---|---|
|
Infections and infestations
Sinus Infection
|
16.7%
1/6 • Number of events 1 • 142 days (16 week intervention + 30 day follow-up)
|
|
Reproductive system and breast disorders
Hidadrenitis Suppertiva Flare-Intravaginal
|
16.7%
1/6 • Number of events 1 • 142 days (16 week intervention + 30 day follow-up)
|
|
Infections and infestations
Urinary Tract Infection
|
33.3%
2/6 • Number of events 2 • 142 days (16 week intervention + 30 day follow-up)
|
|
Infections and infestations
Strep Throat
|
33.3%
2/6 • Number of events 2 • 142 days (16 week intervention + 30 day follow-up)
|
|
Nervous system disorders
Concussion
|
16.7%
1/6 • Number of events 1 • 142 days (16 week intervention + 30 day follow-up)
|
|
Renal and urinary disorders
Interstitial Cystitis Pain
|
16.7%
1/6 • Number of events 1 • 142 days (16 week intervention + 30 day follow-up)
|
|
Ear and labyrinth disorders
ear infection
|
33.3%
2/6 • Number of events 2 • 142 days (16 week intervention + 30 day follow-up)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
16.7%
1/6 • Number of events 1 • 142 days (16 week intervention + 30 day follow-up)
|
|
Skin and subcutaneous tissue disorders
Hidadrenitis Suppertiva flare-right inner thigh
|
16.7%
1/6 • Number of events 1 • 142 days (16 week intervention + 30 day follow-up)
|
|
General disorders
Tooth pain
|
16.7%
1/6 • Number of events 1 • 142 days (16 week intervention + 30 day follow-up)
|
|
General disorders
Gum burning
|
16.7%
1/6 • Number of events 1 • 142 days (16 week intervention + 30 day follow-up)
|
|
Skin and subcutaneous tissue disorders
Hidadrenitis Supertiva flare-groin
|
16.7%
1/6 • Number of events 1 • 142 days (16 week intervention + 30 day follow-up)
|
|
Skin and subcutaneous tissue disorders
Hidadrenitis Supertiva flare-left axilla
|
16.7%
1/6 • Number of events 1 • 142 days (16 week intervention + 30 day follow-up)
|
|
Nervous system disorders
Migraines
|
16.7%
1/6 • Number of events 1 • 142 days (16 week intervention + 30 day follow-up)
|
|
General disorders
Sinus congestion
|
16.7%
1/6 • Number of events 1 • 142 days (16 week intervention + 30 day follow-up)
|
|
General disorders
rhinorrhea
|
16.7%
1/6 • Number of events 1 • 142 days (16 week intervention + 30 day follow-up)
|
Additional Information
Dr. Andrea Zaenglein
Penn State Hershey College of Medicine
Phone: 717-531-8521
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place