Discoid Lupus ErythematosusPhase 2NCT06261021
Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus
A Phase 2 study testing Ruxolitinib 1.5% cream, Application without occlusion in Area 1 and Application under occlusion at night in Area 2 in people with Discoid Lupus Erythematosus, run by Innovaderm Research Inc. at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Discoid Lupus Erythematosus
- What is being tested?
- Ruxolitinib 1.5% cream, Application without occlusion in Area 1 and Application under occlusion at night in Area 2
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- 19 Apr 2024to 28 Feb 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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]).
Show all 14Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
INNO-6051 Site 03
Fredericton, New Brunswick, E3B 1G9
Melissa Bernal
- Recruiting
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1
Lydia Edjekouane
About this study
Official title: 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.
Read the 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
- Being tested
- 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
- Keywords
- discoid lupus erythematosus, opzelura, ruxolitinib cream
- Medical subject headings
- Lupus Erythematosus, Discoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ruxolitinib 1.5% creamDrug
Topical application of Ruxolitinib 1.5% cream
Application without occlusion in Area 1Procedure or surgery
Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 1.
Application under occlusion at night in Area 2Procedure or surgery
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 1Procedure or surgery
Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 1.
Application without occlusion in Area 2Procedure or surgery
Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 2.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Ruxolitinib 1.5% cream; Procedure: Application under occlusion at night in Area 1; Procedure: Application without occlusion in Area 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 24
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start19 Apr 2024
- Primary completion28 Feb 2026 (estimated)
- Study completion28 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discoid Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intra-individual
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD, Principal investigator, Innovaderm Research Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06261021
- Sponsor's protocol ID
- INNO-6051
- Status last verified
- Mar 2025
- First submitted
- 30 Jan 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Single-Blind, Intraindividual Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06261021
- Acronym / sponsor ID
- INNO-6051
- Conditions
- Discoid Lupus Erythematosus
- Keywords
- discoid lupus erythematosus, opzelura, ruxolitinib cream
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Study start
- 19 Apr 2024 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 28 Feb 2026 (estimated)
- First posted
- 15 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Intra-individual
| Arm | Type | Receives |
|---|---|---|
| ruxolitinib 1.5% cream (Sequence 1) | Experimental | Drug: Ruxolitinib 1.5% cream, Procedure: Application without occlusion in Area 1, Procedure: Application under occlusion at night in Area 2ruxolitinib 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) | Experimental | Drug: Ruxolitinib 1.5% cream, Procedure: Application under occlusion at night in Area 1, Procedure: Application without occlusion in Area 2ruxolitinib 1.5% cream under occlusion at night for Area 1 and ruxolitinib 1.5% cream without occlusion for Area 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ruxolitinib 1.5% creamTopical application of Ruxolitinib 1.5% cream | Drug | ruxolitinib 1.5% cream ( Sequence 2), ruxolitinib 1.5% cream (Sequence 1) |
| Application without occlusion in Area 1Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 1. | Procedure or surgery | ruxolitinib 1.5% cream (Sequence 1) |
| Application under occlusion at night in Area 2Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 2. | Procedure or surgery | ruxolitinib 1.5% cream (Sequence 1) |
| Application under occlusion at night in Area 1Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion under occlusion at night on Area 1. | Procedure or surgery | ruxolitinib 1.5% cream ( Sequence 2) |
| Application without occlusion in Area 2Apply Ruxolitinib 1.5% cream on the discoid lupus erythematosus lesion without occlusion on Area 2. | Procedure or surgery | ruxolitinib 1.5% cream ( Sequence 2) |
Primary outcome
Change from baseline in target lesion CLASI-A score
Time frame: 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.
4 secondary outcomes
Change from baseline in target lesion CLASI-A score
Time frame: Week 12, Week 24
Proportion of subjects with an erythema score of 0 (absent)
Time frame: Week 24
Change from baseline in target lesion SADDLE-A
Time frame: Week 12, Week 24
Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear)
Time frame: Week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Discoid Lupus Erythematosus
Active, not recruitingPhase 2/3
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Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus
Not yet recruitingPhase 2/3
Phase 2/3 Double-Blind, Placebo-Controlled Study of Afimetoran in Cutaneous Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systematic Lupus Erythematosus
Active, not recruitingPhase 2
The Willow LTE Study With M5049 in Participants With SCLE, DLE and/or SLE (WILLOW LTE)
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RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Robert Bissonnette, MD principal investigator
Innovaderm Research Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruxolitinib 1.5% cream, Application without occlusion in Area 1 and Application under occlusion at night in Area 2 in people with Discoid Lupus Erythematosus, run by Innovaderm Research Inc. at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fareheen Chowdhury (514-521-4285 ext. 341, fchowdhury@innovaderm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in target lesion CLASI-A score (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.