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RECRUITING Phase 2

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 · View on ClinicalTrials.gov ↗

Study 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 Studied

Interventions

  • DRUG Obinutuzumab
  • DRUG Placebo
  • DRUG Mycophenolate Mofetil
  • DRUG Acetaminophen/paracetamol
  • DRUG Diphenhydramine hydrochloride (HCl)

Study Locations (20)

Other

  • Universidade Federal de Sao Paulo - UNIFES — São Paulo
  • CH de Bicêtre — Le Kremlin-Bicêtre
  • Hôpital Robert Debré — Paris
  • Hop Necker Enfants Malades — Paris

California

  • Loma Linda University health — Loma Linda
  • UCSF Benioff Childrens Hospital — San Francisco

São Paulo

  • Centro de Pesquisa São Lucas — Campinas
  • Hospital das Clinicas - FMUSP — São Paulo

Colorado

  • Children's Hospital Colorado, Anchutz Medical Campus — Aurora

Georgia

  • Emory Children's Center — Atlanta

Indiana

  • Indiana University Health University Hospital — Indianapolis

Louisiana

  • Louisiana State University — Shreveport

New Jersey

  • Hackensack University Medical Center — Hackensack

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2022-05-12
Est. Completion 2030-06-14
Phase Phase 2

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05039619

The ClinicalTrials.gov registry entry for NCT05039619 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Lupus Nephritis appearing as the primary indexed condition, and to 5 interventions — of which Obinutuzumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05039619 reports 20 study locations spanning 15 distinct geographic areas — top geographies include Other, California, São Paulo. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05039619 about?

NCT05039619 is a clinical study titled "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". 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 ...

What is the current status of trial NCT05039619?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2022-05-12. Estimated completion is 2030-06-14.

What conditions does trial NCT05039619 study?

This clinical trial studies the following conditions: Lupus Nephritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05039619?

The interventions under investigation include: Obinutuzumab (DRUG), Placebo (DRUG), Mycophenolate Mofetil (DRUG), Acetaminophen/paracetamol (DRUG), Diphenhydramine hydrochloride (HCl) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05039619?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05039619 being conducted?

This trial has 20 study locations across California, Colorado, Georgia, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial