Prurigo Nodularis Clinical Trial
Official title:
A Maximal Use Trial of Ruxolitinib Cream in Adult Participants With Prurigo Nodularis
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).
Status | Recruiting |
Enrollment | 24 |
Est. completion date | December 9, 2024 |
Est. primary completion date | December 9, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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/Exclusion Criteria may apply. |
Country | Name | City | State |
---|---|---|---|
United States | Oakland Hills Dermatology Pc | Auburn Hills | Michigan |
United States | Dermresearch, Inc. | Austin | Texas |
United States | Olympian Clinical Research | Clearwater | Florida |
United States | Lane Dermatology and Dermatologic Surgery | Columbus | Georgia |
United States | First Oc Dermatology | Fountain Valley | California |
United States | North Texas Center For Clinical Research Ntccr | Frisco | Texas |
United States | Dawes Fretzin Clinical Research Group Llc | Indianapolis | Indiana |
United States | Advanced Pharma Cr, Llc | Miami | Florida |
United States | International Clinical Research Tennessee Llc | Murfreesboro | Tennessee |
United States | Sullivan Dermatology North Miami Beach Office | North Miami Beach | Florida |
United States | Central Sooner Research | Oklahoma City | Oklahoma |
United States | Paddington Testing Co Inc | Philadelphia | Pennsylvania |
United States | Clinical Science Institute Clinical Research Specialists Inc | Santa Monica | California |
United States | Affiliated Dermatology | Scottsdale | Arizona |
United States | Revival Research Institute, Llc Troy | Troy | Michigan |
Lead Sponsor | Collaborator |
---|---|
Incyte Corporation |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with Treatment-emergent Adverse Events (TEAEs) | Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug. | Up to 16 weeks, including 30 days of safety follow-up | |
Primary | Number of participants with TEAEs leading to dose interruption or discontinuation | Number of participants with TEAEs leading to dose interruption or discontinuation. | Up to 16 weeks, including 30 days of safety follow-up | |
Secondary | Ruxolitinib pharmacokinetic (PK) parameters in plasma | Ruxolitinib concentration in plasma. | Up to 16 weeks, including 30 days of safety follow-up |
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