New study enrolling patients with lupus membranous nephropathy (LMN)
Study Title: A Phase 2, Randomized, Double-Blind, Multicenter Study Evaluating the Safety and Efficacy of Filgotinib and GS-9876 in Subjects with Lupus Membranous Nephropathy (LMN)
Sponsor: Gilead Sciences, Inc.
Purpose: This study is designed to evaluate the safety and efficacy of two different investigational drugs (filgotinib and GS-9876) in patients with LMN who continue to have protein in their urine despite being treated with available therapies.
What Does this Study Involve?
After an initial screening period, approximately 32 patients with LMN will be enrolled in this study. Each participant will be randomly assigned to the GS-9876 group (to receive GS-9876 and placebo) or the filgotinib group (to receive filgotinib and placebo) for the first 16 weeks. Neither you nor your study doctor will know the specific drug that you are assigned to.
At Week 16, the results of a urine test will determine whether you continue in your assigned group or switch to the other group starting at Week 16 and continuing to Week 32. The group and study drug you are on will continue to be unknown to you and your study doctor whether you stay on your original study drug or switch to the opposite study drug.
At Week 32, results of a urine test will determine whether you continue in the same group you were in at Weeks 16-32 or you are switched to the other group starting at Week 32 and continuing to Week 52.
Depending on how your body reacts to the study drug(s) at Weeks 1-16 and Weeks 16-32, your study doctor may switch you to the course of study drugs which had better results for you, regardless of the urine test results. The group and study drugs you are on will continue to be unknown to you and your study doctor.
Overall, this study will last up to about 1 year and 1 month, and during this time, you will visit the clinic at least 18 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 between 18 to 75 years of age
- Have had a kidney biopsy within 36 months prior to screening with a diagnosis of LMN (Class V lupus nephritis)
- Have urine protein excretion ≥ 1.5 grams per day based on 24 hour urine sample collected during screening
- Have already tried at least one LMN medication (immunosuppressive therapy) for a sufficient duration before screening
If you have any of the following, you cannot participate in the study:
- Uncontrolled high blood pressure
- 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) < 40 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
- Any history of, or current, inflammatory or autoimmune disease other than systemic lupus erythematosus.
Note that additional inclusion/exclusion criteria may apply, please speak to a doctor at a study center.
To learn more about the study, email GS-USfirstname.lastname@example.org.
Visit the clinicaltrials.gov posting to find a list of the study centers.
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.