Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Obinutuzumab for Lupus Nephritis

This phase II, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study is designed to measure the safety, how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT05039619 · Hoffmann-La Roche · enrollment listed as 40

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Obinutuzumab, Placebo, or Mycophenolate Mofetil. The registry lists allocation as randomized. This phase II, randomly assigned, neither you nor the study doctors know who gets the real treatment, compared with a dummy treatment study is designed to measure the safety, how well it works and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN).

They plan to enroll about 40 people at 44 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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)

Interventions: Obinutuzumab, Placebo, Mycophenolate Mofetil, Acetaminophen/paracetamol, Diphenhydramine hydrochloride (HCl), Methylprednisolone, Prednisone

Primary outcome (registry wording): Percentage of Participants who Achieve a Complete Renal Response (CRR) (AP)

Who it is for (from inclusion criteria)

  • Ages 5 Years to 17 Years
  • Participants who are age 12 to \<18 years at the time of randomization
  • Participants who are age 5 to \<12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population)
  • International Society of Nephrology and the Renal Pathology Society (ISN/RPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening
  • Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible
  • Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria
  • Significant proteinuria defined by a UPCR above \> 0.5 based on a first-morning void (FMV) collection at screening
  • During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg/kg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN

Public study contact (from the registry)

Reference Study ID Number: WA42985 https://forpatients.roche.com/ No attachments to email below.

888-662-6728 (U.S. and Canada)

global.rochegenentechtrials@roche.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

44 listed

+ 33 sites outside the US on the same record

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NCT00001372 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

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FAQ about this NCT record

Is NCT05039619 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05039619?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05039619?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary