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

Phase 2

Recruiting

• Conditions: Discoid Lupus Erythematosus
• Interventions: Drug: Ruxolitinib 1.5% cream; Procedure: Application without occlusion in Area 1; Procedure: Application under occlusion at night in Area 1; Procedure: Application under occlusion at night in Area 2; Procedure: Application without occlusion in Area 2

• Registration Number: NCT06261021
• Lead Sponsor: Innovaderm Research Inc.

Brief Summary

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

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 Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-02-14
• Study First Posted: 2024-02-15
• Study Start: 2024-04-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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 urine pregnancy test at screening and negative urine pregnancy test at Day 1.
• Subject has no known history of latent or active tuberculosis (TB) infection.
• 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 has a known history of chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus [HIV]).
• 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 used JAK inhibitors for conditions other than DLE or other forms of lupus within 4 weeks prior to Day 1.
• Subject has a known history of clinically significant drug or alcohol abuse in the last year prior to Day 1.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ruxolitinib 1.5% cream (Sequence 1)	Application without occlusion in Area 1	ruxolitinib 1.5% cream without occlusion for Area 1 and ruxolitinib 1.5% cream under occlusion at night for Area 2
ruxolitinib 1.5% cream (Sequence 1)	Application under occlusion at night in Area 2	ruxolitinib 1.5% cream without occlusion for Area 1 and ruxolitinib 1.5% cream under occlusion at night for Area 2
ruxolitinib 1.5% cream ( Sequence 2)	Application under occlusion at night in Area 1	ruxolitinib 1.5% cream under occlusion at night for Area 1 and ruxolitinib 1.5% cream without occlusion for Area 2
ruxolitinib 1.5% cream ( Sequence 2)	Application without occlusion in Area 2	ruxolitinib 1.5% cream under occlusion at night for Area 1 and ruxolitinib 1.5% cream without occlusion for Area 2
ruxolitinib 1.5% cream (Sequence 1)	Ruxolitinib 1.5% cream	ruxolitinib 1.5% cream without occlusion for Area 1 and ruxolitinib 1.5% cream under occlusion at night for Area 2
ruxolitinib 1.5% cream ( Sequence 2)	Ruxolitinib 1.5% cream	ruxolitinib 1.5% cream under occlusion at night for Area 1 and ruxolitinib 1.5% cream without occlusion for Area 2

Primary Outcome Measures

Name	Time	Method
Change from baseline in target lesion CLASI-A score	Week 24	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with an erythema score of 0 (absent)	Week 24	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.
Change from baseline in target lesion SADDLE-A	Week 12, Week 24	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
Change from baseline in target lesion CLASI-A score	Week 12, Week 24	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.
Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear)	Week 24	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.

Trial Locations

Locations (2)

INNO-6051 Site 03; 🇨🇦 Fredericton, New Brunswick, Canada

Innovaderm Research Inc.; 🇨🇦 Montréal, Quebec, Canada