Clinical trial NCT06261021: Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Discoid Lupus Erythematosus
Keywords: discoid lupus erythematosus
opzelura
ruxolitinib cream
Lead sponsor: Innovaderm Research Inc.
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intra-individual
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from baseline in target lesion CLASI-A score
timeFrame: Week 24
Secondary outcomes:
measure: Change from baseline in target lesion CLASI-A score
timeFrame: Week 12, Week 24
measure: Proportion of subjects with an erythema score of 0 (absent)
timeFrame: Week 24
measure: Change from baseline in target lesion SADDLE-A
timeFrame: Week 12, Week 24
measure: Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear)
timeFrame: Week 24
Other outcomes:
measure: Dermatology Life Quality Index (DLQI)
timeFrame: Weeks 12 and 24
measure: Cutaneous Lupus Erythematosus Quality of Life (CLEQol)
timeFrame: Weeks 12 and 24
measure: Numeric Rating Scale(NRS)
timeFrame: Weeks 12 and 24
Locations:
city: Fredericton
country: Canada
facility: INNO-6051 Site 03
state: New Brunswick
city: Montréal
country: Canada
facility: Innovaderm Research Inc.
state: Quebec
Study officials:
affiliation: Innovaderm Research Inc.
name: Robert Bissonnette, MD
role: PRINCIPAL_INVESTIGATOR
References: