A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream

Prurigo Nodularis Clinical Trial

Official title:

A Maximal Use Trial of Ruxolitinib Cream in Adult Participants With Prurigo Nodularis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06213831
• Other study ID #: INCB18424-110
• Status: Recruiting
• Phase: Phase 1
• 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
• 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.

Related Conditions & MeSH terms

• Neurodermatitis
• Prurigo
• Prurigo Nodularis

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