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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06213831
Other study ID # INCB18424-110
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date February 27, 2024
Est. completion date December 9, 2024

Study information

Verified date April 2024
Source Incyte Corporation
Contact Incyte Corporation Call Center (US)
Phone 1.855.463.3463
Email medinfo@incyte.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ruxolitinib Cream 1.5%
Ruxolitinib Cream 1.5%

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Incyte Corporation

Country where clinical trial is conducted

United States, 

Outcome

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
See also
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Recruiting NCT05764161 - A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN) Phase 3
Completed NCT02196324 - A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN) Phase 2
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Completed NCT05052983 - A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis Phase 3
Active, not recruiting NCT04204616 - A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) Phase 3