Status:
COMPLETED
A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream
Lead Sponsor:
Incyte Corporation
Conditions:
Prurigo Nodularis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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).
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2025
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT06213831
Start Date
February 27 2024
End Date
July 17 2025
Last Update
August 13 2025
Active Locations (20)
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1
Saguaro Dermatology
Phoenix, Arizona, United States, 85008
2
Affiliated Dermatology
Scottsdale, Arizona, United States, 85255
3
First Oc Dermatology
Fountain Valley, California, United States, 92708
4
Amicis Research Center Valencia
Northridge, California, United States, 91324