A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream
- Registration Number
- NCT06213831
- Lead Sponsor
- Incyte Corporation
- Brief Summary
This study is being conducted to determine the safety and tolerability of ruxolitinib 1.5% cream under maximal use conditions in participants with Prurigo Nodularis (PN).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- Clinical diagnosis of PN ≥ 3 months before screening.
- Pruriginous lesions (defined as papules, nodules, plaques, umbilicated lesions, and linear lesions) on ≥ 2 different body areas (such as right and left leg) at screening and baseline.
- Total estimated treatment BSA ≥ 25% (excluding the scalp) at screening and baseline.
- IGA-CPG-S score of ≥ 2 at screening and baseline.
- Baseline PN-related WI-NRS score ≥ 7. Baseline WI-NRS score is defined as the 7-day average of WI-NRS scores before Day 1 (data from a minimum of 4 out of 7 days prior to Day 1 is needed).
- Chronic or acute pruritus due to a condition other than PN.
- Active AD lesions (signs and symptoms other than dry skin) within 6 months of screening and baseline.
- Acute or chronic active HBV or HCV infection.
- Any underlying condition known to be associated with the clinical presentation of PN that is not under control (stable) prior to the baseline visit.
- Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study cream and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
Other protocol-defined Inclusion/Exclusion Criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Maximal Use Ruxolitinib 1.5% Ruxolitinib Cream 1.5% Participants will apply ruxolitinib 1.5% cream BID through Week 4 to all pruriginous lesions. At Week 4, participants who have completed 4 weeks of treatment with no safety concerns may enter the optional 4-week treatment extension period, during which all participants will apply ruxolitinib 1.5% cream BID to existing pruriginous lesions.
- Primary Outcome Measures
Name Time Method Number of participants with Treatment-emergent Adverse Events (TEAEs) Up to 16 weeks, including 30 days of safety follow-up Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug.
Number of participants with TEAEs leading to dose interruption or discontinuation Up to 16 weeks, including 30 days of safety follow-up Number of participants with TEAEs leading to dose interruption or discontinuation.
- Secondary Outcome Measures
Name Time Method Ruxolitinib pharmacokinetic (PK) parameters in plasma Up to 16 weeks, including 30 days of safety follow-up Ruxolitinib concentration in plasma.
Trial Locations
- Locations (21)
Equity Medical, Llc
🇺🇸New York, New York, United States
Saguaro Dermatology
🇺🇸Phoenix, Arizona, United States
Affiliated Dermatology
🇺🇸Scottsdale, Arizona, United States
First Oc Dermatology
🇺🇸Fountain Valley, California, United States
Amicis Research Center Valencia
🇺🇸Northridge, California, United States
Clinical Science Institute Clinical Research Specialists Inc
🇺🇸Santa Monica, California, United States
Advanced Pharma Cr, Llc
🇺🇸Miami, Florida, United States
Sullivan Dermatology North Miami Beach Office
🇺🇸North Miami Beach, Florida, United States
Olympian Clinical Research
🇺🇸Tampa, Florida, United States
Lane Dermatology and Dermatologic Surgery
🇺🇸Columbus, Georgia, United States
St Lukes Clinic Dermatology Ketchum
🇺🇸Ketchum, Idaho, United States
Dawes Fretzin Clinical Research Group Llc
🇺🇸Indianapolis, Indiana, United States
Equity Medical
🇺🇸Bowling Green, Kentucky, United States
Oakland Hills Dermatology Pc
🇺🇸Auburn Hills, Michigan, United States
Revival Research Institute, Llc Troy
🇺🇸Troy, Michigan, United States
Red River Research Partners
🇺🇸Fargo, North Dakota, United States
Central Sooner Research
🇺🇸Oklahoma City, Oklahoma, United States
Paddington Testing Co Inc
🇺🇸Philadelphia, Pennsylvania, United States
International Clinical Research Tennessee Llc
🇺🇸Murfreesboro, Tennessee, United States
Dermresearch, Inc.
🇺🇸Austin, Texas, United States
North Texas Center For Clinical Research Ntccr
🇺🇸Frisco, Texas, United States