Recruiting

Phase 2

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

Sponsor:

Innovaderm Research Inc.

Code:

NCT06261021

Conditions

Discoid Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ruxolitinib 1.5% cream

Application without occlusion in Area 1

Application under occlusion at night in Area 2

Application under occlusion at night in Area 1

Application without occlusion in Area 2

Study Details

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

Study ID

NCT06261021

Start date

Apr 19, 2024

Status verified date

Mar, 2025

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Feb 28, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

Interventions

Ruxolitinib 1.5% cream

Topical application of Ruxolitinib 1.5% cream

Application without occlusion in Area 1

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

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.

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.

Application without occlusion in Area 2

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

Primary outcome measure

Change from baseline in target lesion CLASI-A score [ Time Frame: Week 24 ]

Central Contacts and Locations

Central contacts

Fareheen Chowdhury

514-521-4285 fchowdhury@innovaderm.com

Locations

INNO-6051 Site 03

Recruiting

Fredericton, New Brunswick, Canada, E3B 1G9

Innovaderm Research Inc.

Recruiting

Montréal, Quebec, Canada, H2X 2V1

More Information

Sponsor

Innovaderm Research Inc.

Last update posted

Mar 24, 2025

Last verified

Mar, 2025

Keywords

discoid lupus erythematosus
opzelura
ruxolitinib cream

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Innovaderm Research Inc. on 2025-03-24.