MS504908_0001 Elowen-1
Research type
Research Study
Full title
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
IRAS ID
1013809
Contact name
Global Affairs
Contact email
Sponsor organisation
Merck Healthcare KGaA
Clinicaltrials.gov Identifier
Research summary
Enpatoran is a study drug that is being tested to see if it can help treat people with skin or other organ problems of lupus erythematosus, an autoimmune (self-attack) disease. This is a Phase 3 study and the purpose of this research study is to find out how well and safely the study drug works for people who have skin problems of lupus erythematosus, even if they also have a condition known as Systemic Lupus Erythematosus (SLE), while they are receiving their usual treatment (standard of care).
The study drug has been tested in patients with both Cutaneous Lupus Erythematosus (CLE) and SLE, and earlier studies found it to be safe and well tolerated overall.
This is a double-blind placebo-controlled study which means that neither participants nor the study doctor will know who is receiving the actual treatment and who is receiving a placebo (a substance with no treatment effect). This is also a randomised study where participants will be assigned to different treatment groups by chance. This random assignment is designed to determine which treatment is most effective.
This study has three parts:
- Screening Period: one visit of approximately 8-10 hours
- Treatment Period: 5 visits of approximately 2-3 hours and 3 visits of approximately 6-7 hours.
- Safety Follow-up Period: 1 visit of approximately 2-3 hours. Participation in this research study will last for about 35 weeks.
It is expected that about 202 people will take part in this study in total, which will be conducted at around 150 medical centre(s) internationally.REC name
London - London Bridge Research Ethics Committee
REC reference
26/LO/0322
Date of REC Opinion
2 Jun 2026
REC opinion
Further Information Favourable Opinion