Hidradenitis Suppurativa
Conditions
Keywords
Hidradenitis suppurativa, skin disease, ruxolitinb cream
Brief summary
The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult and adolescent participants with hidradenitis suppurativa.
Interventions
DRUGRuxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Sponsors
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of HS for at least 6 months before screening visit. * Diagnosis of HS (Hurley Stage I, II, III) with a total abscess and inflammatory nodule count of at least 4 and affecting at least 3 distinct anatomical areas at screening and Day 1 visits. * Total estimated treatment BSA \> 20% at screening and baseline. * Agreement to not use topical or systemic antibiotics for treatment of HS during the Maximal Use Treatment Period. * Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol. * Further inclusion criteria apply.
Exclusion criteria
* Current or history of skin condition(s) other than HS that might confound the evaluation of HS; clinically uncontrolled cardiovascular disease; thrombosis; certain cancers; certain infections; severe anemia, thrombocytopenia, or neutropenia; other medical conditions at the discretion of the investigator. * Laboratory values outside of the protocol-defined ranges. * Further
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with Treatment-emergent Adverse Events (TEAEs) | Up to 24 weeks | Defined as adverse events reported for the first time or worsening of a pre-existing event after the first application of study drug. |
| Number of participants with TEAEs leading to treatment interruption, discontinuation | Up to 24 weeks | Number of participants with TEAEs leading to dose interruption or discontinuation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics Parameter (PK): Cmax of INCB018424 | Up to 24 weeks | Defined as maximum observed plasma concentration of INCB018424. |
| Pharmacokinetics Parameter: Tmax of INCB018424 | Up to 24 weeks | Defined as the time to reach the maximum plasma concentration of INCB018424. |
| Pharmacokinetics Parameter: AUC 0-12 of INCB018424 | Up to 24 weeks | Defined as the area under the plasma or serum concentration-time curve from Hour 0 to 12 hours of INCB018424. |
Countries
United States
Contacts
CONTACTIncyte Corporation Call Center (US)
CONTACTIncyte Corporation Call Center (ex-US)
STUDY_DIRECTORIncyte Medical Monitor
Incyte Corporation
Outcome results
None listed