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A clinical trial to compare obinutuzumab with placebo in adolescents with lupus nephritis (POSTERITY)
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
- Autoimmune Disorder
- Lupus Nephritis
Please note that the recruitment status of the trial at your site may differ from the overall study status because some study sites may recruit earlier than others.
Trial Status:
Recruiting
This trial runs in
Cities
- Atlanta
- Aurora
- Bahia
- Cape Town
- Cincinnati
- Ciudad de México
- El Paso
- Esplugues de Llobregat
- Gdańsk
- Genoa
- Glasgow
- Guadalajara
- Hackensack
- Indianapolis
- Le Kremlin-Bicêtre
- Lima
- Liverpool
- Loma Linda
- London
- Madrid
- Milano
- Monterrey
- Montréal
- Moscow
- New York
- Paris
- Philadelphia
- Roma
- Saint Petersburg
- San Francisco
- San Isidro
- Shreveport
- São Paulo
- Toronto
- Toruń
- Toulouse
- València
Trial Identifier:
NCT05039619 2021-000097-29 2023-505825-15-00 WA42985
Trial Summary
This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to <12 with LN.
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT05039619, WA42985, 2021-000097-29,2023-505825-15-00
Trial Identifier
All
Gender
≥5 Years & ≤ 17 Years
Age
No
Healthy Volunteers
How does the POSTERITY (WA42985) clinical trial work?
This clinical trial is recruiting adolescents who have active lupus nephritis (LN).
The purpose of this clinical trial is to compare the effects, good or bad, of obinutuzumab against placebo in patients with lupus nephritis. If you take part in this clinical trial, you will receive either obinutuzumab or placebo (a substance that looks like obinutuzumab but contains no active ingredients), in addition to your usual treatment of corticosteroids and mycophenolate mofetil (MMF).
How do I take part in this clinical trial?
To be able to take part in this clinical trial, you must be at least 12 years old and less than 18 years old at the start of the clinical trial, have been diagnosed with lupus nephritis according to certain criteria, and have been treated with at least one dose of intravenous (into the vein) methylprednisolone (or similar) in the last 12 months.
You must not have severe, active central nervous system systemic lupus erythematosus (SLE) or severely damaged kidneys, according to certain criteria. If you have an active infection or are taking certain medications, you may not be able to take part in this clinical trial.
If you think this clinical trial may be suitable for you and would like to take part, please talk to your doctor. If your doctor thinks that you might be able to take part in this clinical trial, they may refer you to the closest clinical trial doctor. They will give you all the information you need to make your decision about taking part in the clinical trial. You can also find the clinical trial locations on this page.
You will have some further tests to make sure you will be able to take the treatments given in this clinical trial. Some of these tests or procedures may be part of your regular medical care. They may be done even if you do not take part in the clinical trial. If you have had some of the tests recently, they may not need to be done again.
Before starting the clinical trial, you will be told about any risks and benefits of taking part in the trial. You will also be told what other treatments are available so that you may decide if you still want to take part.
While taking part in the clinical trial, both male and female patients (who are not currently pregnant but could become pregnant) will need to either not have heterosexual intercourse or take contraceptive medication for safety reasons.
What treatment will I be given if I join this clinical trial?
Everyone who joins this clinical trial will enter a screening/observation period to make sure they are able to take part. Patients will be split into two groups randomly (like flipping a coin) and given either:
- Obinutuzumab as an infusion into the vein on Days 1 and 14, then six months later at Weeks 24 and 26 and again six months later at Week 52
- OR placebo as an infusion into the vein on Days 1 and 14, then six months later at Weeks 24 and 26, and again six months later at Week 52.
You will have a 2 in 3 chance of being placed in the obinutuzumab group and a 1 in 3 chance of being placed in the placebo group. No matter which group you are placed in, you will still receive corticosteroids and MMF treatment every day for your lupus nephritis, as tablets to be swallowed.
This is a ‘placebo-controlled’ clinical trial, which means that one of the groups will be given medicine with no active ingredients (also known as a ‘placebo’). A placebo is used to show that the doctor or the patients do not sway the results of the clinical trial.
Neither you nor your clinical trial doctor can choose or know the group you are in. However, your clinical trial doctor can find out which group you are in if your safety is at risk.
How often will I be seen in follow-up appointments and for how long?
You will be given the clinical trial treatment obinutuzumab or placebo for roughly 18 months. You are free to stop this treatment at any time. You will be seen regularly by the clinical trial doctor in 11 visits over the 18-month period. These hospital visits will include checks to see how you are responding to the treatment and any side effects that you may be having. Safety follow-up visits after your last infusion of clinical trial treatment will occur every six months for at least 12 months. You may need to make additional visits if your clinical trial doctor feels it is necessary.
What happens if I am unable to take part in this clinical trial?
If this clinical trial is not suitable for you, you will not be able to take part. Your doctor will suggest other clinical trials that you may be able to take part in or other treatments that you can be given. You will not lose access to any of your regular care.
For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov
Trial-identifier: NCT05039619
Trial Summary
This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to <12 with LN.
Hoffmann-La Roche
Sponsor
Phase 2
Phase
NCT05039619, WA42985, 2021-000097-29,2023-505825-15-00
Trial Identifier
Obinutuzumab, Placebo, Mycophenolate Mofetil, Acetaminophen/paracetamol, Diphenhydramine hydrochloride (HCl), Methylprednisolone, Prednisone
Treatments
Lupus Nephritis
Condition
Official Title
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Safety and PK in a Cohort of Pediatric Patients (Aged 5 to < 12)
Eligibility Criteria
All
Gender
≥5 Years & ≤ 17 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Participants who are age 12 to <18 years at the time of randomization
- Participants who are age 5 to <12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population)
- International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening
- Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible
- Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria
- Significant proteinuria defined by a UPCR above > 0.5 based on a first-morning void (FMV) collection at screening
- During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg/kg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN.
Exclusion Criteria
- Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia
- Sclerosis in >50% of glomeruli on renal biopsy
- Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions
- Presence of rapidly progressive glomerulonephritis
- Pure Class V LN
- Intolerance or contraindication to study therapies
- Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization
- History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders
- History of serious recurrent or chronic infection
- History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the past 5 years
- Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation
- Currently active alcohol or drug abuse or history of alcohol or drug abuse
For the latest version of this information please go to www.forpatients.roche.com