A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care
About this study
A clinical research study is being conducted to evaluate an investigational medicine called enpatoran in people with lupus erythematosus who have active skin symptoms, with or without systemic involvement.
Enpatoran is not approved by the Therapeutic Goods Administration (TGA) for use in Australia or any other country, and is only available within clinical research settings. The purpose of this study is to assess the safety and effectiveness of enpatoran when taken in addition to standard treatment.
Who is eligible to participate?
- Aged 18–75 years
- Are an adult with lupus erythematosus
- Have active skin symptoms related to lupus
- Are currently receiving standard treatment
What’s involved?
- Up to 35 weeks participation
- Random assignment to receive enpatoran or placebo (by chance)
- Regular study visits and safety assessments
- Continued use of your usual lupus treatment
Parking and meals can be reimbursed if required.
Participation is voluntary, and all study procedures will be explained in detail before you decide whether to take part.
Study details
- HREC Project Number: 149/26
- Approved by: Alfred Hospital Ethics Committee
Contact
Dermatology trials team | E: dermtrials@alfred.org.au | T: 03 9076 8592