Clinical trial NCT05593432: A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
Official title: A Randomized, Double-Blind, Vehicle-Controlled Study of the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cutaneous Lichen Planus
Keywords: Lichen Planus
Skin Diseases
18424
Ruxolitinib
topical cream
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-10-25
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study will include a 16 week double-blind period followed by a 16 week open-label period.
Primary purpose: TREATMENT

Brief summary: The purpose of this study will be to evaluate efficacy and safety of Ruxolitinib cream in participants With Cutaneous Lichen Planus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 16 weeks followed by an open label period (OLE) period of 16 weeks.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of LP with predominant cutaneous involvement.
* IGA score of 3 or 4 at screening and baseline.
* Baseline LP-related Itch NRS score ≥ 4.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Concurrent conditions and history of other diseases:

  1. Variants of LP deemed by the investigators to be inappropriate for topical treatment, including but not limited to predominant mucosal (such as oral or vaginal) LP.
  2. Active ongoing inflammatory diseases of the skin other than LP that might confound the evaluation of LP lesions or compromise participant safety.
  3. Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of LP lesions or compromise participant safety.
  4. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).
  5. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
  6. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chickenpox, clinically infected AD, or impetigo) within 1 week before baseline.
* Laboratory values outside of the protocol-defined criteria.
* Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
* Other exclusive criteria may apply.

Primary outcomes:
measure: Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16
timeFrame: Baseline; Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
timeFrame: Baseline; Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
timeFrame: Baseline; Weeks 18, 20, 24, 28, and 32
measure: Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
timeFrame: Baseline; Weeks 2, 4, 8, 12, and 16
measure: Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
timeFrame: Baseline; Weeks 18, 20, 24, 28, and 32
measure: Time to Achieve ITCH4 in the Double-blind, Vehicle-controlled Period
timeFrame: up to Week 16
measure: Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
timeFrame: Baseline; Weeks 2, 4, 8, 12, and 16
measure: Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
timeFrame: Baseline; Weeks 18, 20, 24, 28, and 32
measure: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period
timeFrame: from Baseline to Week 16 plus 30 days
measure: Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period
timeFrame: from Baseline to Week 16 plus 30 days
measure: Number of Participants With Any TEAE During the Open-label Extension Period
timeFrame: from Week 17 to Week 32 plus 30 days
measure: Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period
timeFrame: from Week 17 to Week 32 plus 30 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Dermatology
state: Alabama
city: Phoenix
country: United States
facility: Medical Dermatology Specialists Phoenix
state: Arizona
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Los Angeles
country: United States
facility: Wallace of Beverly Hills
state: California
city: Skokie
country: United States
facility: Northshore Medical Group Dermatology Skokie
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group Llc
state: Indiana
city: Baton Rouge
country: United States
facility: Delricht Clinical Research-Clinedge-Ppds Baton Rouge
state: Louisiana
city: New Orleans
country: United States
facility: Delricht Research - Touro Medical Center
state: Louisiana
city: Rockville
country: United States
facility: Dermassociates
state: Maryland
city: New Brighton
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
city: Las Vegas
country: United States
facility: Jdr Dermatology Research
state: Nevada
city: New York
country: United States
facility: OPTISKIN
state: New York
city: Bexley
country: United States
facility: Bexley Dermatology
state: Ohio
city: Columbus
country: United States
facility: Clinohio Research Services
state: Ohio
city: Mayfield Heights
country: United States
facility: Apex Clinical Research Center
state: Ohio
city: Norman
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania-Perelman School of Medicine
state: Pennsylvania
city: Murfreesboro
country: United States
facility: International Clinical Research Ic Research Murfreesboro
state: Tennessee
city: Arlington
country: United States
facility: Arlington Center For Dermatology
state: Texas
city: Pflugerville
country: United States
facility: Austin Institute For Clinical Research Aicr Pflugerville
state: Texas
city: Murray
country: United States
facility: University of Utah Health Care Midvalley Health Center Dermatology
state: Utah
city: Winnipeg
country: Canada
facility: Wiseman Dermatology Research Inc
state: Manitoba
city: Newmarket
country: Canada
facility: Dr. S. K. Siddha Medicine Professional Corporation
state: Ontario
Study officials:
affiliation: Incyte Corporation
name: Haq Nawaz, MD
role: STUDY_DIRECTOR
References: