Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects With Discoid Lupus Erythematosus

A Phase 2, Single-Blind, Intraindividual Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects With Discoid Lupus Erythematosus

This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.

Study Overview

• Status: Recruiting
• Conditions: Discoid Lupus Erythematosus
• Intervention / Treatment: Drug: Ruxolitinib 1.5% cream; Procedure: Application without occlusion in Area 1; Procedure: Application under occlusion at night in Area 2; Procedure: Application under occlusion at night in Area 1; Procedure: Application without occlusion in Area 2

Detailed Description

This study is being conducted to evaluate the efficacy, safety and tolerability of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus.

Approximately 20 subjects with discoid lupus erythematosus will apply ruxolitinib 1.5% cream, twice daily on active lesions identified at Day 1 and any new lesions that appear, for 24 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Fareheen Chowdhury; Phone Number: 341 514-521-4285; Email: fchowdhury@innovaderm.com

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H2X 2V1
      • Recruiting
      • Innovaderm Research Inc.
      • Contact: Fareheen Chowdhury, MSc; Phone Number: 341 514-521-4285; Email: fchowdhury@innovaderm.com
      • Principal Investigator: Robert Bissonnette

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female subject 18 years of age or older at the time of consent.
• Confirmed DLE diagnosis.
• Subject has moderate to severe DLE, as defined by an overall CLA IGA score of 3 (moderate) or 4 (severe) at screening and Day 1.
• Female subject of childbearing potential must have a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1.
• Subject is willing to participate and is capable of giving informed consent. Note: Consent must be obtained prior to any study-related procedures.
• Subjects must be willing to comply with all study procedures and must be available for the duration of the study.

Exclusion Criteria:

• Female subject who is breastfeeding, pregnant, or who is planning to become pregnant during the study.
• Subject has a history of skin disease or presence of skin condition that would interfere with the study assessments.
• Subject has unstable or fluctuating use of nicotine-containing products within 4 weeks prior to screening.
• Subject is known to have immune deficiency or is immunocompromised.
• Subject is ≥ 50 years old AND has a history of heart attack, other clinically significant heart problems, stroke, or blood clots.
• Subject is known to have hepatitis B or hepatitis C viral infection.
• Subject has used any topical medicated treatment that could affect DLE within 2 weeks prior to Day 1, including, but not limited to, topical corticosteroids, retinoids, calcineurin inhibitors, antimicrobials, and medical devices.
• Subject has received any marketed or investigational biological agent within 12 weeks or 5 half lives (whichever is longer) prior to Day 1, including but not limited to ustekinumab and rituximab.
• Subject is currently receiving a nonbiological investigational product or device or has received one within 4 weeks prior to Day 1.
• Subject has a known or suspected allergy to ruxolitinib.
• Subject has used ruxolitinib cream (OpzeluraTM).
• Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ruxolitinib 1.5% cream (Sequence 1); ruxolitinib 1.5% cream without occlusion for Area 1 and ruxolitinib 1.5% cream under occlusion at night for Area 2	Drug: Ruxolitinib 1.5% cream; Topical application of Ruxolitinib 1.5% cream; Procedure: Application without occlusion in Area 1; Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 1.; Procedure: Application under occlusion at night in Area 2; Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 2.
Experimental: ruxolitinib 1.5% cream ( Sequence 2); ruxolitinib 1.5% cream under occlusion at night for Area 1 and ruxolitinib 1.5% cream without occlusion for Area 2	Drug: Ruxolitinib 1.5% cream; Topical application of Ruxolitinib 1.5% cream; Procedure: Application under occlusion at night in Area 1; Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 1.; Procedure: Application without occlusion in Area 2; Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in target lesion CLASI-A score	The CLASI-A (Cutaneous Lupus Area and Severity Index - Activity) quantifies disease activity based on scoring of erythema, scale/hypertrophy, mucous membrane involvement, acute hair loss, and non scarring alopecia. Change from baseline in target lesion CLASI-A score at Week 24 for the target DLE lesion treated with occlusion The CLASI-A score ranges from 0 to 70, with higher scores indicating more severe skin disease.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in target lesion CLASI-A score	The CLASI-A (Cutaneous Lupus Area and Severity Index - Activity) quantifies disease activity based on scoring of erythema, scale/hypertrophy, mucous membrane involvement, acute hair loss, and non scarring alopecia. Change from baseline in target lesion CLASI-A score at Week 24 for the target DLE lesion treated without occlusion. The CLASI-A score ranges from 0 to 70, with higher scores indicating more severe skin disease.	Week 12, Week 24
Proportion of subjects with an erythema score of 0 (absent)	Proportion of subjects with an erythema score of 0 (absent) in 50% of all DLE lesions. Erythema will be assessed for each DLE lesion identified on Day 1 using the erythema component of the CLASI-A scale. The severity of erythema is scored on a 4-point scale ranging from 0 (absent) to 3.	Week 24
Change from baseline in target lesion SADDLE-A	Change from baseline in target lesion SADDLE-A at Week 24 for the target DLE lesion treated with and without occlusion. Change from baseline in target lesion SADDLE-A score at Week 12 for the untreated target DLE lesion and the target DLE lesion treated with and without occlusion	Week 12, Week 24
Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear)	Proportion of subjects with a CLA-IGA score of 0 (clear) or 1 (almost clear) for all DLE lesions. The CLA-IGA is a 5 point scale that evaluates the severity of signs of the overall disease activity based on erythema, scale, edema/ infiltration, follicular involvement, and secondary changes.	Week 24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dermatology Life Quality Index (DLQI)	Change from baseline in DLQI. Quality of life will be evaluated using Dermatology Life Quality Index (DLQI). It is a simple 10-question validated questionnaire that has been used in more than 40 different skin conditions.The DLQI is the most frequently used instrument in studies of randomized controlled trials in dermatology.	Weeks 12 and 24
Cutaneous Lupus Erythematosus Quality of Life (CLEQol)	Change from baseline in CLEQoL total score.Quality of life will be evaluated using the Cutaneous Lupus Erythematosus Quality of Life (CLEQoL).The CLEQoL asks subjects to assess how often (never, rarely, sometimes, often, all the time) they experienced a given effect. Scores of 0 (never), 25 (rarely), 50 (sometimes), 75 (often), or 100 (all the time) are assigned to each question. The scores are averaged per domain from the scale of 0-100, with higher numbers indicating worse quality of life.	Weeks 12 and 24
Numeric Rating Scale(NRS)	Change from baseline in target lesion pruritus NRS scores.Pruritus numeric rating scale (NRS) will also be evaluated as an efficacy assessment for each of the 2 (or 3, as applicable) target lesions.This will be evaluated by asking subjects to assign a numerical score representing worst itch intensity over the last 24 hours of each target lesion on a scale from 0 to 10, with 0 indicating no itch and 10 indicating the worst imaginable itch.	Weeks 12 and 24

Collaborators and Investigators

• Sponsor: Innovaderm Research Inc.
• Investigators: Principal Investigator: Robert Bissonnette, MD, Innovaderm Research Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 14, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: discoid lupus erythematosus; ruxolitinib cream; opzelura
• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Cutaneous; Lupus Erythematosus, Systemic; Lupus Erythematosus, Discoid
• Other Study ID Numbers: INNO-6051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No