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Obinutuzumab - POSTERITY

Obinutuzumab is a humanized, type II anti-CD20 monoclonal antibody that has a distinct mode of binding to the CD20 antigen compared with type I anti-CD20 antibodies and is glycoengineered for greater affinity for the FcγRIII on effector cells. These properties promote greater antibody-dependent cellular cytotoxicity, superior direct B-cell killing, and, thus, less reliance on complement-dependent cytotoxicity than type I anti-CD20 antibodies.

Wavy Abstract Background

Enroll in this clinical study

Reference Study ID Number: WA42985 https://forpatients.roche.com/

888-662-6728 (U.S. and Canada)

global.rochegenentechtrials@roche.com

How is Obinutuzumab being studied in Lupus nephritis?

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 pharmacokinetics in a cohort of pediatric patients (Aged 5 to < 12) is being studied in this Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study.

Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV)  vs matched placebo infusions on Day 1, Day 14, Week 24, Week 26 and Week 52.

 

Participants with a body weight of 45 kg or more will receive the 1000 mg dose. Participants with a body weight below 45 kg will receive a weight adjusted dose of 20 mg/kilogram (kg).

 

The primary outcome of the study is the percentage of participants who achieve a Complete Renal Response.

Eligibility Criteria

  1. Participants who are age 12 to <18 years at the time of randomization

  2. Participants who are age 5 to <12 years (younger participant cohort) at the time of randomization once recruitment is open.

  3. International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN

  4. Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible

  5. Significant proteinuria defined by a UPCR above > 0.5

  6. During the 12 months before 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.

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