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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Cahaba Dermatology
Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16
The Investigator's Global Assessment (IGA) is a modified global assessment tool to assess the severity of lesions. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at Week 16.
Time frame: Baseline; Week 16
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
The IGA is a global assessment tool to assess the severity of lesions. The IGA includes items such as depigmentation/hypopigmentation, lichenification (fine wrinkling/cigarette paper skin), excoriations, petechiae/ecchymosis, telangiectasias, erosions, fissures, or ulcers. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at each scheduled post-Baseline visit. Participants with a score of 0 have a morphology of: no inflammatory signs (no erythema, no induration/papulation). Postinflammatory hyperpigmentation and/or hypopigmentation may be present. Participants with a score of 1 have a morphology of: barely perceptible erythema, barely perceptible induration/papulation/elevation, and/or minimal scale. Features include palpable, slightly erythematous papules.
Time frame: Baseline; Weeks 2, 4, 8, 12, and 16
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
The IGA is a global assessment tool to assess the severity of lesions. The IGA includes items such as depigmentation/hypopigmentation, lichenification (fine wrinkling/cigarette paper skin), excoriations, petechiae/ecchymosis, telangiectasias, erosions, fissures, or ulcers. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at each scheduled post-Baseline visit. Participants with a score of 0 have a morphology of: no inflammatory signs (no erythema, no induration/papulation). Postinflammatory hyperpigmentation and/or hypopigmentation may be present. Participants with a score of 1 have a morphology of: barely perceptible erythema, barely perceptible induration/papulation/elevation, and/or minimal scale. Features include palpable, slightly erythematous papules.
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Birmingham, Alabama, United States
Medical Dermatology Specialists Phoenix
Phoenix, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
Wallace of Beverly Hills
Los Angeles, California, United States
Northshore Medical Group Dermatology Skokie
Skokie, Illinois, United States
Dawes Fretzin Clinical Research Group Llc
Indianapolis, Indiana, United States
Delricht Clinical Research-Clinedge-Ppds Baton Rouge
Baton Rouge, Louisiana, United States
Delricht Research - Touro Medical Center
New Orleans, Louisiana, United States
Dermassociates
Rockville, Maryland, United States
Minnesota Clinical Study Center
New Brighton, Minnesota, United States
...and 14 more locations
Time frame: Baseline; Weeks 18, 20, 24, 28, and 32
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
Time frame: Baseline; Weeks 2, 4, 8, 12, and 16
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
Time frame: Baseline; Weeks 18, 20, 24, 28, and 32
Time to Achieve ITCH4 in the Double-blind, Vehicle-controlled Period
ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
Time frame: up to Week 16
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen planus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Weeks 2, 4, 8, 12, and 16
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen planus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time frame: Baseline; Weeks 18, 20, 24, 28, and 32
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Time frame: from Baseline to Week 16 plus 30 days
Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period
A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Time frame: from Baseline to Week 16 plus 30 days
Number of Participants With Any TEAE During the Open-label Extension Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Time frame: from Week 17 to Week 32 plus 30 days
Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period
A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the CTCAE v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Time frame: from Week 17 to Week 32 plus 30 days