Health Trials

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

ConditionLupus Nephritis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age5-17
SponsorHoffmann-La Roche

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 3 treatment groups
Group A: Blinded ObinutuzumabExperimental treatment 6 interventions
Group B: PlaceboPlacebo comparator 6 interventions
Group C: Open-Label ObinutuzumabExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP)

CRR is defined as achievement of all of the following: * Urinary protein-to-creatinine ratio (UPCR) \<0.5 g/g * Estimated Glomerular Filtration Rate (eGFR) \>=85% of baseline * No occurrence of intercurrent events

Time frame
Week 76
2

Percentage of Participants with Adverse Events (PP)

Time frame
Baseline to Week 76

Secondary outcomes

1

Percentage of Participants Achieving a CRR (AP)

Time frame
Weeks 24 and 52
2

Percentage of Participants who Achieve CRR with Successful Prednisone Taper (AP)

Time frame
Week 76
3

Percentage of Participants who Achieve a PRR (AP)

Time frame
Week 76
4

Percentage of Participants Achieving an Overall Response (CRR or PRR) (AP)

PRR is defined as: achievement of all of the following: * \>=50% reduction in urinary protein-to-creatinine ratio (UPCR) from baseline * UPCR \< 1 g/g (or \< 3 g/g if the baseline UPCR was \>=3 g/g) * eGFR \>=85% of baseline * No occurrence of intercurrent events

Time frame
Weeks 24, 52, and 76

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Saint-Petersburg StateWithdrawn194100, St-peterburg, Sankt-PeterburgRussiaRussia

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Genentech, Inc.

Collaborator

Source ClinicalTrials.gov
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