Spotlight on an investigational treatment for lupus: the NOBILITY study
Study Title: A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of Obinutuzumab in patients with ISN/RPS 2003 CLASS III or IV Lupus Nephritis (“NOBILITY”)
Sponsor: F. Hoffmann-La Roche Ltd
Purpose: The NOBILITY study is looking at the safety and efficacy of obinutuzumab. The study will explore the occurrence and rate of potential side-effects and to see if obinutuzumab can reduce a particular type of immune cells (B-cells) and thereby improve the signs and symptoms in patients with lupus nephritis, which is when lupus impacts the kidney.
Study Type: A randomized double-blind, placebo-controlled, multicenter study conducted in about 70 centers worldwide.
To consider participation in this study you must:
- Be between 18-75 years old
- Have received a diagnosis of ISN/RPS 2003 class III or IV lupus nephritis
- Have a level of protein in your urine and be committed to abstain from pregnancy for at least twelve months after the study ends
If you have any of the following, you may not be able to participate in the study:
- Retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke or stroke syndrome, cerebellar ataxia or dementia that is currently active and resulting from SLE
- Presence of rapidly progressive glomerulonephritis
- Severe renal impairment as defined by estimated glomerular filtration rate (GFR) <30 mL per minute or the need for dialysis or renal transplant
- Greater than 50% of glomeruli with sclerosis on renal biopsy
What does the NOBILITY study involve?
The study has an initial screening phase which may take up to 28 days followed by a 52-week treatment period and 52‑week follow‑up phase. During screening, you will need to undergo various tests to ensure you are suitable to take part in this study. You will be asked to sign a consent form if you agree to enter the study.
Before or during the screening period, and depending on the prior treatment of your current flare, you may receive between one and three doses of 1000-mg methylprednisolone (a corticosteroid) to treat your lupus nephritis.
Upon entry into the treatment phase of the study, you will be randomly assigned by a computer program to one of the following treatment groups: obinutuzumab plus mycophenolate mofetil (MMF) or mycophenolic acid (MPA) or placebo plus MMF or MPA.
When you are "randomized" into the study, this means that you are put into a group by chance (like tossing a coin). Neither you nor your study doctor may choose the group you will be in. You will have an equal chance of being placed in either group. Neither you nor your study doctor will know which treatment you receive. If your safety is at risk, your study doctor can find out which drug you are receiving.
You will receive the obinutuzumab or placebo saline infusion on Days one, 15, 168 and 182 of the study.
Starting from Day 16 of the treatment phase, you will gradually reduce your dose of daily corticosteroids over a 12-week period. Your study doctor will check you for signs and symptoms associated with a flare of your lupus nephritis and for other signs of steroid withdrawal. During the 52-week treatment phase, you will be attending regular visits to the study site where your doctor will check your disease activity and check for side effects. During each visit, you will be required to provide blood samples and also urine samples at some visits.
At the end of the treatment phase you will be asked to provide a repeat kidney biopsy so we can see whether your disease has improved. This is not a requirement of the study, and you may decide to participate in the study but not to have a repeat kidney biopsy. During the follow-up phase of the study, which is approximately one year, you will be asked to attend two clinic visits every six months.
To find out more about the NOBILITY study, email email@example.com or call (888) 662-6728.
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.