New study of investigational treatments for cutaneous lupus erythematosus in women
Study Title: A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety and Efficacy of Filgotinib and GS-9876 in Female Subjects With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
Sponsor: Gilead Sciences, Inc.
Purpose: The purpose of this study is to evaluate the safety and efficacy of two different investigational drugs (filgotinib and GS-9876) in women with active Cutaneous Lupus Erythematosus (lupus skin lesions).
What Does this Study Involve?
After an initial screening period, approximately 50 women with CLE will be enrolled in this study. Each participant will be randomly assigned to receive GS-9876, filgotinib or placebo (inactive tablets) for the first 12 weeks. Neither you nor your study doctor will know the specific drug that you are assigned to.
At week 12, the women who were initially on placebo tablets will be re-assigned to either GS-9876 or filgotinib. After 24 weeks on the study, participants will have the option to continue taking the study drug for another 24 weeks. Overall, this study will last up to about 1 year, and during this time, you will visit the clinic at least 14 times. You may stop being in the study at any time. The decision to participate in this study is entirely up to you.
To consider participation in this study you must:
- Be female and between 18 to 75 years of age
- Have a diagnosis with CLE with active skin lesions
- Note: you may also have a diagnosis of SLE (systemic lupus erythematosus), but that SLE is not required
- Have already tried at least one CLE medication
If you have any of the following, you cannot participate in the study:
- Use of certain medications (the study doctor will discuss these with you)
- Moderate or severe kidney disease (defined as an estimated glomerular filtration rate (GFR) < 60 mL per minute)
- Malignancy (cancer) within 5 years of screening, except for successfully treated basal or non-metastatic squamous cell carcinomas of the skin or a cervical carcinoma in situ
To find out more about the study, email GS-USemail@example.com.
Visit the clinicaltrials.gov posting to find a list of the study centers in your area
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
The Lupus Foundation of America works to educate and inform about clinical trial study options available to people with lupus and the importance of getting involved to help advance lupus research. The Lupus Foundation of America does not endorse specific trials.