Recruiting NCT07049575
Study to Evaluate the Maximal Use of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ruxolitinib Cream.
- Who it may be relevant to
- Registry conditions: Hidradenitis Suppurativa. Basic parameters: 12 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Maximal Use Trial of Ruxolitinib Cream in Adult and Adolescent Participants With Hidradenitis Suppurativa
Overview
The purpose of this study is to evaluate the maximal use of ruxolitinib cream in adult and adolescent participants with hidradenitis suppurativa.
Interventions
- Drug Ruxolitinib Cream
Ruxolitinib cream applied topically to the affected area as a thin film twice daily.
Primary outcome measures
- Number of participants with Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to 24 weeks]
- Number of participants with TEAEs leading to treatment interruption, discontinuation [Time frame: Up to 24 weeks]
Secondary outcome measures (3)
- Pharmacokinetics Parameter (PK): Cmax of INCB018424 [Time frame: Up to 24 weeks]
- Pharmacokinetics Parameter: Tmax of INCB018424 [Time frame: Up to 24 weeks]
- Pharmacokinetics Parameter: AUC 0-12 of INCB018424 [Time frame: Up to 24 weeks]
Eligibility criteria
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 exclusion criteria apply.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 21 centers
- Saguaro Dermatology — Phoenix
- First Oc Dermatology — Fountain Valley
- Amicis Research Center Valencia — Northridge
- Children'S Hospital of Orange County — Orange
- Clinical Trials Research Institute — Thousand Oaks
- Clarity Dermatology — Castle Rock
- International Clinical Research Tennessee Llc — Sanford
- Lenus Research Medical Group, Llc — Sweetwater
- … and 13 more centers
Identifiers
NCT: NCT07049575 · INCB018424-112