Obinutuzumab
DrugObinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1, Day 14, Week 24, Week 26 and Week 52.
Other names: Gazyva
NCT Number: NCT05039619
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.
Interested in participating?
Request Info5 year–17 year
All sexes
Interventional
Phase 2
Ser Servicos Especializados Em Reumatologia, Salvador, Estado de Bahia, Brazil
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1, Day 14, Week 24, Week 26 and Week 52.
Other names: Gazyva
Placebo matching obinutuzumab will be administered by IV on Day 1, Day 14, Week 24, Week 26 and Week 52.
Mycophenolate Mofetil (MMF) will be taken by home administration orally at a target dose of 1200 mg/m^2/day to a maximum of 2.5g/day from baseline (Day 1) onwards.
Acetaminophen 1000 mg will be administered as pre-medication prior to infusions.
Diphenhydramine HCl 50 mg will be administered as pre-medication prior to infusions.
Methylprednisolone 80 mg IV will be administered as pre-medication prior to infusions.
Oral prednisone or equivalent corticosteroid will be taken by home administration daily to a maximum dose of 60mg/day followed by a guided taper to 5mg/day or less by Week 24.
Time frame: Week 76
CRR is defined as achievement of all of the following:
Time frame: Baseline to Week 76
Time frame: Weeks 24 and 52
Time frame: Week 76
Time frame: Week 76
Time frame: Weeks 24, 52, and 76
PRR is defined as:
achievement of all of the following:
Time frame: Baseline to Week 76
Time frame: Baseline to Week 76
Time frame: Up to Week 76
Time frame: Week 12 to Week 76
Time frame: Baseline to Week 76
Time frame: Baseline to Week 76
Time frame: Baseline to Week 76
Time frame: Baseline to Week 76
Time frame: Baseline to Week 76
Time frame: Baseline, Weeks 4, 24, 52 and 76
Time frame: Baseline to Week 76
Time frame: Baseline to Week 76
Time frame: Baseline to Week 76
Time frame: Weeks 0, 24, 52 and 76
Time frame: Weeks 24, 52 and 76
Time frame: Week 76
Time frame: Week 76
PRR is defined as achievement of all of the following:
Time frame: Week 76
Time frame: Baseline to Week 76
Time frame: Baseline, Weeks 4, 24, 52 and 76
Time frame: Weeks 0, 24, 52 and 76
Time frame: Baseline to Week 76
Contact information is provided by the study sponsor or research team.
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Reference Study ID Number: WA42985 https://forpatients.roche.com/ No attachments to email below.
CONTACT
888-662-6728 (U.S. and Canada)
Hoffmann-La Roche
Industry
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)
Acronym: POSTERITY
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07053800
Autoimmune Diseases, Connective Tissue Diseases
Syracuse, New York, United States
View Trial DetailsNCT07598396
Autoimmune Diseases, Connective Tissue Diseases
Salvador, Estado de Bahia, Brazil
View Trial DetailsNCT06217107
Autoimmune Diseases, Connective Tissue Diseases
Atlanta, Georgia, United States
View Trial DetailsNCT06925542
Autoimmune Diseases, Connective Tissue Diseases
Redwood City, California, United States
View Trial Details