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

NCT06261021 | Recruiting Phase 2

• 1 other identifier: INNO-6051
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Discoid Lupus Erythematosus

Keywords

discoid lupus erythematosus; opzelura; ruxolitinib cream

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline in target lesion CLASI-A score

  Week 12, Week 24

• Proportion of subjects with an erythema score of 0 (absent)

  Week 24

• Change from baseline in target lesion SADDLE-A

  Week 12, Week 24

• Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear)

  Week 24

Other Outcomes (3)

• Dermatology Life Quality Index (DLQI)

  Weeks 12 and 24

• Cutaneous Lupus Erythematosus Quality of Life (CLEQol)

  Weeks 12 and 24

• Numeric Rating Scale(NRS)

  Weeks 12 and 24

Study Arms (2)

ruxolitinib 1.5% cream (Sequence 1)

EXPERIMENTAL

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; Procedure: Application without occlusion in Area 1; Procedure: Application under occlusion at night in Area 2

ruxolitinib 1.5% cream ( Sequence 2)

EXPERIMENTAL

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; Procedure: Application under occlusion at night in Area 1; Procedure: Application without occlusion in Area 2

Interventions

Ruxolitinib 1.5% cream DRUG

Topical application of Ruxolitinib 1.5% cream

ruxolitinib 1.5% cream ( Sequence 2); ruxolitinib 1.5% cream (Sequence 1)

Application without occlusion in Area 1 PROCEDURE

Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 1.

ruxolitinib 1.5% cream (Sequence 1)

Application under occlusion at night in Area 2 PROCEDURE

Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 2.

ruxolitinib 1.5% cream (Sequence 1)

Application under occlusion at night in Area 1 PROCEDURE

Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 1.

ruxolitinib 1.5% cream ( Sequence 2)

Application without occlusion in Area 2 PROCEDURE

Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 2.

ruxolitinib 1.5% cream ( Sequence 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Innovaderm Research Inc.: lead

Study Sites (2)

INNO-6051 Site 03

Fredericton, New Brunswick, E3B 1G9, Canada

RECRUITING

Innovaderm Research Inc.

Montreal, Quebec, H2X 2V1, Canada

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Discoid

Interventions

ruxolitinib; Salicylic Acid

Condition Hierarchy (Ancestors)

Lupus Erythematosus, Cutaneous; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols

Study Officials

• Robert Bissonnette, MD

  Innovaderm Research Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fareheen Chowdhury

CONTACT

514-521-4285; fchowdhury@innovaderm.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study will be single-blinded. Only the efficacy assessor will be blinded in this study (for subjects with randomized areas). The assessor will only assess efficacy and will not have any other interactions with the subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intra-individual

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 15, 2024
• Study Start: April 19, 2024
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)