Skip to content

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)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505825-15-00
Acronym
WA42985
Enrollment
10
Registered
2024-08-27
Start date
2021-10-29
Completion date
Unknown
Last updated
2025-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis (LN)

Brief summary

1. Proportion of participants who achieve a complete renal response (CRR) at Week 76 (AP), 2. Incidence, nature, and severity of AEs, Incidence of laboratory or vital sign abnormalities from baseline to Week 76 analysis and serum concentrations of obinutuzumab at specified timepoints (PP)

Detailed description

1. Proportion of adolescent participants achieving a CRR at Weeks 24 and 52 (AP), 2. Proportion of participants who achieve CRR with successful prednisone taper at Week 76, defined as achievement of CRR (as above) at Week 76 with the following: – No receipt of prednisone > 7.5 mg/day (or equivalent) from Week 64 through Week 76, 3. Proportion of participants who achieve a partial renal response (PRR) at Week 76. PRR is defined as achievement of all of the following: – ≥ 50% reduction in UPCR from baseline – UPCR < 1 g/g (or < 3 g/g if the baseline UPCR was ≥ 3 g/g) – eGFR ≥ 85% of baseline – No occurrence of intercurrent events, 4. Proportion of adolescent participants achieving an overall response (CRR or PRR) at Weeks 24, 52, and 76 (AP), 5. Change in urinary protein-to-creatinine ratio (UPCR) from baseline to Week 76 (AP), 6. Change in estimated glomerular filtration rate (eGFR) from baseline to Week 76 (AP), 7. Time to onset of CRR over the course of 76 weeks (AP), 8. Proportion of participants who experience treatment failure from Week 12 to Week 76 (AP), 9. Change in anti dsDNA titers from baseline to Week 76, 10. Change in C3 complement levels from baseline to Week 76 (AP), 11. Change in C4 complement levels from baseline to Week 76 (AP), 12. Incidence, nature, and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) from baseline to Week 76 (AP), 13. Incidence of laboratory or vital sign abnormalities from baseline to Week 76 (AP), 14. Serum concentrations of obinutuzumab at specified timepoints (AP), 15. Proportion of participants achieving B-cell depletion, at specified timepoints, 16. Change in Pediatric Quality of Life Inventory-Multidimensional Fatigue scale (PedsQL)-Fatigue total score from baseline to Week 76 (AP), 17. Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) from baseline to Week 76 (AP), 18. Change from baseline in Child Health Questionnaire-Parent Form 28 (CHQ-PF28) domain scores from baseline to Week 76 (AP), 19. Proportion of participants with anti-drug antibodies (ADA) at weeks 0, 24, 52 and 76, 20.Relationship between ADA status and efficacy, safety, pharmacodynamic, or PK endpoints, 21. Proportion of patients achieving a complete renal response (CRR) at Week 76 (PP), 22. Proportion of patients achieving an overall response, defined as achieving a complete or partial renal response (PRR) at Week 76 (PP), 23. Proportion of participants who achieve CRR with successful prednisone taper at Week 76, defined as achievement of CRR (as above) at Week 76 with the following (PP) – No receipt of prednisone > 7.5 mg/day (or equivalent) from Week 64 through Week 76, 24. Change in eGFR from baseline to Week 76 (PP), 25. Change in anti-dsDNA titers from baseline to Week 76

Interventions

DRUGGazyvaro 1
DRUG000 mg concentrate for solution for infusion.
DRUGGazyvaro Placebo

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 17 Years

Design outcomes

Primary

MeasureTime frame
1. Proportion of participants who achieve a complete renal response (CRR) at Week 76 (AP), 2. Incidence, nature, and severity of AEs, Incidence of laboratory or vital sign abnormalities from baseline to Week 76 analysis and serum concentrations of obinutuzumab at specified timepoints (PP)

Secondary

MeasureTime frame
1. Proportion of adolescent participants achieving a CRR at Weeks 24 and 52 (AP), 2. Proportion of participants who achieve CRR with successful prednisone taper at Week 76, defined as achievement of CRR (as above) at Week 76 with the following: – No receipt of prednisone > 7.5 mg/day (or equivalent) from Week 64 through Week 76, 3. Proportion of participants who achieve a partial renal response (PRR) at Week 76. PRR is defined as achievement of all of the following: – ≥ 50% reduction in UPCR from baseline – UPCR < 1 g/g (or < 3 g/g if the baseline UPCR was ≥ 3 g/g) – eGFR ≥ 85% of baseline – No occurrence of intercurrent events, 4. Proportion of adolescent participants achieving an overall response (CRR or PRR) at Weeks 24, 52, and 76 (AP), 5. Change in urinary protein-to-creatinine ratio (UPCR) from baseline to Week 76 (AP), 6. Change in estimated glomerular filtration rate (eGFR) from baseline to Week 76 (AP), 7. Time to onset of CRR over the course of 76 weeks (AP), 8. Proportion of

Countries

France, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026