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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: Recruiting Phase 2 study of Lupus Nephritis, sponsored by Hoffmann-La Roche.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
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 |
What NCT05039619 shows while recruiting
NCT05039619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 309-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (87% lower).
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 names 20 study sites across 15 states, led by 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
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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.
Where NCT05039619's enrollment target sits among peer trials
40 23rd of 30 higher than 8 of 30 other Lupus Nephritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Nephritis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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