Clinical trial NCT06213831: A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream
Official title: A Maximal Use Trial of Ruxolitinib Cream in Adult Participants With Prurigo Nodularis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Prurigo Nodularis
Keywords: Prurigo Nodularis
PN
ruxolitinib
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2024-01-19
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Number of participants with Treatment-emergent Adverse Events (TEAEs)
timeFrame: Up to 16 weeks, including 30 days of safety follow-up
measure: Number of participants with TEAEs leading to dose interruption or discontinuation
timeFrame: Up to 16 weeks, including 30 days of safety follow-up
Secondary outcomes:
measure: Ruxolitinib pharmacokinetic (PK) parameters in plasma
timeFrame: Up to 16 weeks, including 30 days of safety follow-up
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Saguaro Dermatology
state: Arizona
city: Scottsdale
country: United States
facility: Affiliated Dermatology
state: Arizona
city: Fountain Valley
country: United States
facility: First Oc Dermatology
state: California
city: Northridge
country: United States
facility: Amicis Research Center Valencia
state: California
city: Santa Monica
country: United States
facility: Clinical Science Institute Clinical Research Specialists Inc
state: California
city: Miami
country: United States
facility: Advanced Pharma Cr, Llc
state: Florida
city: North Miami Beach
country: United States
facility: Sullivan Dermatology North Miami Beach Office
state: Florida
city: Tampa
country: United States
facility: Olympian Clinical Research
state: Florida
city: Ketchum
country: United States
facility: St Lukes Clinic Dermatology Ketchum
state: Idaho
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group Llc
state: Indiana
city: Bowling Green
country: United States
facility: Equity Medical
state: Kentucky
city: Auburn Hills
country: United States
facility: Oakland Hills Dermatology Pc
state: Michigan
city: Troy
country: United States
facility: Revival Research Institute, Llc Troy
state: Michigan
city: New York
country: United States
facility: Equity Medical, Llc
state: New York
city: Fargo
country: United States
facility: Red River Research Partners
state: North Dakota
city: Oklahoma City
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Philadelphia
country: United States
facility: Paddington Testing Co Inc
state: Pennsylvania
city: Murfreesboro
country: United States
facility: International Clinical Research Tennessee Llc
state: Tennessee
city: Austin
country: United States
facility: Dermresearch, Inc.
state: Texas
city: Frisco
country: United States
facility: North Texas Center For Clinical Research Ntccr
state: Texas
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: