NCT05039619

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

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 5 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Obinutuzumab	Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1, Day 14, Week 24, Week 26 and Week 52.
DRUG	Placebo	Placebo matching obinutuzumab will be administered by IV on Day 1, Day 14, Week 24, Week 26 and Week 52.
DRUG	Mycophenolate Mofetil	Mycophenolate Mofetil (MMF) will be taken by home administration orally at a target dose of 1200 mg/m\^2/day to a maximum of 2.5g/day from baseline (Day 1) onwards.
DRUG	Acetaminophen/paracetamol	Acetaminophen 1000 mg will be administered as pre-medication prior to infusions.
DRUG	Diphenhydramine hydrochloride (HCl)	Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.
DRUG	Methylprednisolone	Methylprednisolone 80 mg IV will be administered as pre-medication prior to infusions.
DRUG	Prednisone	Oral prednisone or equivalent corticosteroid will be taken by home administration daily to a maximum dose of 60mg/day followed by a guided taper to 5mg/day or less by Week 24.

Timeline

• Start date: 2022-05-12
• Primary completion: 2028-06-15
• Completion: 2030-06-14
• First posted: 2021-09-09
• Last updated: 2026-04-03

Locations

42 sites across 12 countries: United States, Brazil, Canada, France, Italy, Mexico, Peru, Poland, Russia, South Africa, Spain, United Kingdom

Regulatory

• FDA-regulated drug study