Obinutuzumab + Standard Therapy for Lupus Nephritis
(REGENCY Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if adding obinutuzumab to standard treatments is safe and effective for patients with severe kidney inflammation from lupus. It helps the immune system remove harmful cells and has shown better results in kidney health compared to standard treatments alone.
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but it does require that you have not taken certain medications like anti-CD20 therapy in the last 9 months or cyclophosphamide, tacrolimus, ciclosporin, or voclosporin in the last 2 months before screening.
Is the combination of Obinutuzumab and standard therapy safe for treating lupus nephritis?
What makes the drug Obinutuzumab with Prednisone unique for lupus nephritis?
What data supports the effectiveness of the drug Obinutuzumab combined with standard therapy for treating lupus nephritis?
Research shows that Obinutuzumab, when added to standard lupus nephritis treatment, can help preserve kidney function and achieve better kidney remission compared to some other treatments. It was found to be more effective than placebo in achieving overall kidney remission, indicating its potential benefit in treating lupus nephritis.124910
Who Is on the Research Team?
Clinical Trials
Principal Investigator
Hoffmann-La Roche
Are You a Good Fit for This Trial?
This trial is for patients with Class III or IV lupus nephritis, as confirmed by a biopsy within the last 6 months. Participants must have significant protein in their urine and can't be pregnant, breastfeeding, or have received certain other treatments recently. They also shouldn't have severe kidney issues requiring dialysis or transplant.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive obinutuzumab or placebo infusions at baseline and Weeks 2, 24, 26, 50, and 52, along with standard-of-care therapy consisting of MMF and oral prednisone
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants without an adequate response at Week 76 may be eligible for open-label obinutuzumab starting at Week 80
What Are the Treatments Tested in This Trial?
Interventions
- Methylprednisolone
- Obinutuzumab
- Prednisone
Prednisone is already approved in United States, European Union, Canada for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Hoffmann-La Roche
Lead Sponsor
Dr. Levi Garraway
Hoffmann-La Roche
Chief Medical Officer since 2019
MD from the University of Basel
Dr. Thomas Schinecker
Hoffmann-La Roche
Chief Executive Officer since 2023
PhD in Molecular Biology from New York University