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 (NCT05039619)
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)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Loma Linda University health — Loma Linda, California
Age range: 5 Years to 17 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (43 Sites)
Showing the first 25 of 43 sites.
- Loma Linda University health — Loma Linda, California
- UCSF Benioff Childrens Hospital — San Francisco, California
- Children's Hospital Colorado, Anchutz Medical Campus — Aurora, Colorado
- Emory Children's Center — Atlanta, Georgia
- Indiana University Health University Hospital — Indianapolis, Indiana
- Louisiana State University — Shreveport, Louisiana
- Hackensack University Medical Center — Hackensack, New Jersey
- Cohen Children's Medical Center of New York — Queens, New York
- Cincinnati Childrens Hospital — Cincinnati, Ohio
- Chldren?s Hospital of Philadelphia — Philadelphia, Pennsylvania
- Texas Arthritis Center — El Paso, Texas
- Ser Servicos Especializados Em Reumatologia — Salvador, Estado de Bahia
- Hospital Universitário Onofre Lopes - UFRN — Petrópolis, Rio Grande do Norte
- Centro de Pesquisa São Lucas — Campinas, São Paulo
- Hospital das Clinicas - FMUSP — São Paulo, São Paulo
- Universidade Federal de Sao Paulo - UNIFES — São Paulo,
- The Hospital for Sick Children — Toronto, Ontario
- Hospital Sainte-Justine — Montreal, Quebec
- CH de Bicêtre — Le Kremlin-Bicêtre,
- Hôpital Robert Debré — Paris,
- Hop Necker Enfants Malades — Paris,
- CHU de Toulouse - Hôpital des Enfants — Toulouse,
- Ospedale Pediatrico Bambino Gesu — Rome, Lazio
- IRCCS G. Gaslini — Genoa, Liguria
- Clinica Pediatrica II De Marchi — Milan, Lombardy
📞 Contact the Study Coordinator
Phone: (888) 662-6728
Email: global.rochegenentechtrials@roche.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Lupus Nephritis
- KYSA-1: A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Subjects With Refractory Lupus Nephritis — Palo Alto, California
- Daratumumab to Treat Active Lupus Nephritis — Rochester, Minnesota
- A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis — Birmingham, Alabama
- Phase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis — Glendale, Arizona
- An Open-label Study of Povetacicept in Autoantibody-Associated Glomerular Diseases — Phoenix, Arizona
- Safety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis — Birmingham, Alabama
Explore by condition: All Lupus Nephritis clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.