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RECRUITING
NCT06940661
PHASE2

Obinutuzumab for Remission Induction in Patients With Relapsing PR3-ANCA Granulomatosis With Polyangiitis

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of obinutuzumab to induce clinical and serological remission in patients with relapsing PR3-ANCA granulomatosis with polyangiitis.

Official title: Obinutuzumab for Remission Induction in Patients With Relapsing PR3-ANCA Granulomatosis With Polyangiitis (Wegener's). Phase 2 Prospective, Open-label Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

33

Start Date

2025-12-19

Completion Date

2028-07

Last Updated

2026-03-06

Healthy Volunteers

No

Interventions

DRUG

Obinutuzumab

Patient will receive 1000 milligrams intravenous (IV) infusion on week 0, week 2, week 24 and week 26. Patients will receive the same standardized glucocorticoid tapering schedule (prescribe as a standard of care management and considered as auxiliary medicinal product) Premedication for obinutuzumab infusion related reactions (considered as auxiliary medicinal products) : * 100 mg methylpredinisolone * 1000 mg paracetamol * 5 mg dexchlorpheniramine

Locations (1)

Service de Médecine Interne, Centre de reference "Maladies systémiques et autoimmunes rares, en particulier Vascularites nécrosantes et Sclérodermies systémiques"

Paris, France