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

ClinicalTrials.gov ID: NCT05039619

Public ClinicalTrials.gov record NCT05039619. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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Official title

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)

Study identification

NCT ID: NCT05039619
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Hoffmann-La Roche; Industry
Enrollment: 40 participants

Conditions and interventions

Conditions

Lupus Nephritis

Interventions

Acetaminophen/paracetamol Drug
Diphenhydramine hydrochloride (HCl) Drug
Methylprednisolone Drug
Mycophenolate Mofetil Drug
Obinutuzumab Drug
Placebo Drug
Prednisone Drug

Drug

Eligibility (public fields only)

Age range: 5 Years to 17 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: May 11, 2022
Primary completion: Jun 14, 2028
Completion: Jun 13, 2030
Last update posted: May 3, 2026

2022 – 2030

United States locations

U.S. sites: 11
U.S. states: 10
U.S. cities: 11

Facility	City	State	ZIP	Site status
Loma Linda University health	Loma Linda	California	92354	Recruiting
UCSF Benioff Childrens Hospital	San Francisco	California	94158	Recruiting
Children's Hospital Colorado, Anchutz Medical Campus	Aurora	Colorado	80045	Recruiting
Emory Children's Center	Atlanta	Georgia	30322	Recruiting
Indiana University Health University Hospital	Indianapolis	Indiana	46202	Recruiting
Louisiana State University	Shreveport	Louisiana	71103	Recruiting
Hackensack University Medical Center	Hackensack	New Jersey	07601	Recruiting
Cohen Children's Medical Center of New York	Queens	New York	11042	Recruiting
Cincinnati Childrens Hospital	Cincinnati	Ohio	45229	Recruiting
Chldren?s Hospital of Philadelphia	Philadelphia	Pennsylvania	19104	Withdrawn
Texas Arthritis Center	El Paso	Texas	79902	Withdrawn

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 31 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05039619, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted May 3, 2026 · Synced May 8, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05039619 live on ClinicalTrials.gov.

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