A Phase 2, Single-Blind, Intraindividual Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects with Discoid Lupus Erythematosus

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
INNO-6051 Site 03
RECRUITING
Fredericton
Innovaderm Research Inc.
RECRUITING
Montreal
Contact Information
Primary
Fareheen Chowdhury
fchowdhury@innovaderm.com
514-521-4285
Time Frame
Start Date: 2024-04-19
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 20
Treatments
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
Sponsors
Leads: Innovaderm Research Inc.

This content was sourced from clinicaltrials.gov