Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05039619 · ClinicalTrials.gov registry record · 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
A Phase 2 study of Lupus Nephritis, sponsored by Hoffmann-La Roche.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 20
- Study locations
NCT05039619 is a Phase 2 study of Lupus Nephritis that is actively recruiting participants, run by Hoffmann-La Roche. The registered enrollment target is 40 participants, below the 309-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 15 states.
The verdict
NCT05039619, a Phase 2 study of Lupus Nephritis, is actively recruiting participants, sponsored by Hoffmann-La Roche.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2022-05-12 |
| Est. Completion | 2030-06-14 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 309-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (87% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.
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.
NCT05039619 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, California, São Paulo.
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.
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).
Who is sponsoring clinical trial NCT05039619?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Lupus Nephritis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Study of Efficacy and Safety of LNP023 in Participants With Active Lupus Nephritis Class III-IV, +/- V
RECRUITING · Phase 2
-
The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study
RECRUITING · Phase 2
-
VIBRANT: VIB4920 for Active Lupus Nephritis
RECRUITING · Phase 2
-
A Study of CC-97540 (BMS-986353 or Zola-cel), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
RECRUITING · Phase 2
-
A Study of Rapcabtagene Autoleucel in Active, Refractory Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN) Patients (AUTOGRAPH - SLE/LN)
RECRUITING · Phase 2
-
Daratumumab to Treat Active Lupus Nephritis
ACTIVE NOT RECRUITING · Phase 2
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.