WA42985 OBINUTUZUMAB IN ADOLESCENT PATIENTS WITH LUPUS NEPHRITIS
Research type
Research Study
Full 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
IRAS ID
1003891
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceuticals Division, PDR
Contact email
Sponsor organisation
F. Hoffman-La Roche Ltd.
Eudract number
2021-000097-29
Clinicaltrials.gov Identifier
Research summary
This study is a phase II , randomised double-blind, placebo controlled multicentre study to evaluate the efficacy, safety and pharmacokinetics of obinutuzumab in adolescent patients with active class III or IV lupus nephritis. Current standard of care of lupus nephritis remains limited to a combination of corticosteroids and immunosuppressants, but these only offer a complete renal response in fewer than half of these patients. Obinutuzumab is currently approved drug for chronic lymphocytic leukemia and follicular lymphoma and has been shown to improve lupus nephritis symptoms in adults. This study will aim to find out whether this drug is also of benefit in children and adolescents with the same condition.
30 participants from all over the world and 3 from the UK who are 12 to less than 18 years old will take part in this study; 20 will be given obinutuzumab and 10 will be given a placebo. Eligible participants will be in the study for at least 2 years and for some participants this may increase to 3.5 years or longer. In order to be eligible for the study, participants must have active disease requiring immunosuppressive therapy and evidence of significant proteinuria on a first-morning void of urine collection at screening.
Research Summary; Protocol version 1.0 dated 30th March 2021REC name
Wales REC 5
REC reference
21/WA/0248
Date of REC Opinion
30 Sep 2021
REC opinion
Further Information Favourable Opinion