Purpose of this Study
The study uses a placebo, which is a pill that looks real but has no medicine in it. This helps researchers see how well the study drug works. People who join the study can keep taking some of their regular medicines as long as these medicines follow the study rules.
Who Can Participate?
Eligibility
People can join this study if they are between 18 and 75 years old. They must have active cutaneous lupus erythematosus for at least six months, and their symptoms must meet certain scores during the screening visits. They must also be taking a steady dose of at least one lupus treatment, such as immunomodulators, immunosuppressants, oral steroids, or topical steroids. They must have been taking these medicines for a set amount of time before the study begins.
Age Range
18-75
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
The MS504908 study is trying to learn how well a new medicine called enpatoran works and how safe it is. People in the study have a skin condition called cutaneous lupus erythematosus. They take the medicine by mouth two times each day.
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
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
Principal Investigator
Anne
Marano
Protocol Number
PRO00119550
Phase
III
Enrollment Status
Pending Open to Enrollment