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

Conditions

• Lupus Nephritis

Eligibility Criteria

Sex

ALL

Age

5 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Obinutuzumab — DRUG
  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.
• Placebo — DRUG
  Placebo matching obinutuzumab will be administered by IV on Day 1, Day 14, Week 24, Week 26 and Week 52.
• Mycophenolate Mofetil — DRUG
  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.
• Acetaminophen/paracetamol — DRUG
  Acetaminophen 1000 mg will be administered as pre-medication prior to infusions.
• Diphenhydramine hydrochloride (HCl) — DRUG
  Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.
• Methylprednisolone — DRUG
  Methylprednisolone 80 mg IV will be administered as pre-medication prior to infusions.
• Prednisone — DRUG
  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.

Study Details

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.

Key Dates

Start date

May 12, 2022

Status verified

Jun 2026

Primary completion

Jun 15, 2028

Completion

Jun 14, 2030

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Blinded Obinutuzumab
  Participants will receive obinutuzumab 1000 milligrams (mg) intravenous (IV) 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).
• Placebo Comparator: Placebo
  Placebo participants will receive obinutuzumab matched placebo on Day 1, Day 14, Week 24, Week 26 and Week 52.
• Experimental: Open-Label Obinutuzumab
  Younger participants aged 5 to \<12 will receive obinutuzumab 1000 mg IV infusions on Days 1, 14, Week 24, Week 26 and Week 52.

Primary Outcome Measure

Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP) [ Time Frame: Week 76 ]

Central Contacts

• Reference Study ID Number: WA42985 https://forpatients.roche.com/
  888-662-6728 (U.S. and Canada)
  [email protected]
• Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (11)

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