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

NCT ID: NCT06261021

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-19
• Study Completion Date: 2026-02-28

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.

Conditions

Discoid Lupus Erythematosus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Ruxolitinib 1.5% cream

Intervention Type: DRUG

Topical application of Ruxolitinib 1.5% cream

Application without occlusion in Area 1

Intervention Type: PROCEDURE

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

Application under occlusion at night in Area 2

Intervention Type: PROCEDURE

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

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

Group Type: EXPERIMENTAL

Ruxolitinib 1.5% cream

Intervention Type: DRUG

Topical application of Ruxolitinib 1.5% cream

Application under occlusion at night in Area 1

Intervention Type: PROCEDURE

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

Application without occlusion in Area 2

Intervention Type: PROCEDURE

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

Interventions

Ruxolitinib 1.5% cream

Topical application of Ruxolitinib 1.5% cream

Intervention Type: DRUG

Application without occlusion in Area 1

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

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Application without occlusion in Area 2

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

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Innovaderm Research Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Bissonnette, MD

Role: PRINCIPAL_INVESTIGATOR

Innovaderm Research Inc.

Locations

INNO-6051 Site 03

Fredericton, New Brunswick, Canada

Site Status: RECRUITING

Innovaderm Research Inc.

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Fareheen Chowdhury

Role: CONTACT

fchowdhury@innovaderm.com

514-521-4285 ext. 341

Facility Contacts

Melissa Bernal

Role: primary

Lydia Edjekouane

Role: primary

Other Identifiers

INNO-6051

Identifier Type: -

Identifier Source: org_study_id