Prurigo Nodularis
Conditions
Keywords
Prurigo Nodularis, PN, ruxolitinib
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).
Interventions
Ruxolitinib Cream 1.5%
Sponsors
Incyte Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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).
Exclusion criteria
* 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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Ruxolitinib pharmacokinetic (PK) parameters in plasma | Up to 16 weeks, including 30 days of safety follow-up | Ruxolitinib concentration in plasma. |
Countries
United States
Outcome results
None listed