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

NCT06940661 | Recruiting Phase 2 DMC

• 2 other identifiers: APHP2110002022-501557-36
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Granulomatosis With Polyangiitis

Keywords

Relapsing PR3-ANCA granulomatosis with polyangiitis; Obinutuzumab

Outcome Measures

Primary Outcomes (1)

• the percentage of patients who achieved clinical and serological remission at week 24 (month 6)

  The percentage of patients who achieved clinical and serological remission at week 24 (month 6), defined by: * a BVAS of 0, * a negativation of PR3-ANCA, * and successful completion of the prednisone taper

  week 24

Secondary Outcomes (7)

• Proportion of participants experiencing adverse events and severe adverse events

  Week 24 and 52

• Number and causes of deaths

  Week 52

• Proportion of disease flares, including minor and major relapses

  Week 52

• Proportion of participants who remain with a BVAS of 0 during the treatment period with prednisone at a dose of less than 10 mg per day

  Treatment period

• The time to B-cell repopulation defined by detectable CD19+ B cells in peripheral blood over the 12 months study period

  Week 24 and 52

Study Arms (1)

Single Arm: Obinutuzumab

EXPERIMENTAL

All participants receive obinutuzumab for remission induction

Drug: Obinutuzumab

Interventions

Obinutuzumab DRUG

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

Single Arm: Obinutuzumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient aged of 18 years or older,
• Patients with an active disease defined as a Birmingham Vasculitis Activity Score (BVAS) ≥ 3,
• Patients within the first 21 days following initiation/increase of glucocorticoids at a dose ≤1 mg/kg/day (pulses of methylprednisolone before oral glucocorticoid therapy are authorized)
• Patient able to give written informed consent prior to participation in the study, - Affiliation with a mode of social security (profit or being entitled).

You may not qualify if:

• Patients with MPO-positive AAV, or other vasculitis, defined by the ACR criteria and/or the Chapel Hill Consensus Conference,
• Patients with vasculitis in remission of the disease defined as a BVAS \< 3,
• Patients with a newly-diagnosis of GPA
• Patients with severe cardiac failure defined as class IV in New York Heart Association
• Subject known to be seropositive for human immunodeficiency virus (HIV), hepatitis B (included history of previous infection) or hepatitis C
• Patients with active cancer or recent cancer (\< 5 years), except basocellular carcinoma and prostatic cancer of low activity controlled by hormonal treatment,
• Patients with hypersensitivity to a monoclonal antibody or biologic agent,
• Patients with hypersensitivity to obinutuzumab or to its excipients
• Contra-indications to auxiliary medicinal products (methylprednisolone, paracetamol, prednisone, dexchlorpheniramine)
• Patients with other uncontrolled diseases, including drug or alcohol abuse, active infections or antecedents of chronic or recurrent infections, severe psychiatric diseases, that could interfere with participation in the trial according to the protocol,
• Patients suspected not to be observant to the proposed treatments,
• Pregnant women and lactation. All women of childbearing potential (WOCBP) are required to have a negative pregnancy test (blood or urine) before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using an effective method of birth control from the date of consent through the end of the study, and at least 18 months after stopping obinutuzumab such as combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (Oral, Intravaginal, Transdermal); Progestogen-only hormonal contraception associated with inhibition of ovulation (Oral, Injectable, Implantable); Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner,
• Men who refuse to use effective method of contraception (condom) from the date of consent through the end of the study and at least 18 months after stopping obinutuzumab (unless permanently sterile by bilateral orchidectomy or vasectomy),
• Patient participating in another investigational therapeutic study
• Protected adults (including individual under legal guardianship by court order or curatorship) or adults deprived of liberty

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin: collaborator
• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Paris, 75014, France

RECRUITING

MeSH Terms

Conditions

Granulomatosis with Polyangiitis

Interventions

obinutuzumab

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Xavier PUECHAL, PhD

  Hôpital Cochin, Assistance Publique-Hôpitaux de Paris - Service de Médecine Interne, Centre de référence " Maladies systémiques et autoimmunes rares, en particulier Vascularites nécrosantes et Sclérodermies systémiques "

  STUDY DIRECTOR

Central Study Contacts

Benjamin TERRIER, PhD

CONTACT

01 58 41 14 61; benjamin.terrier@aphp.fr

Karima MESBAHI-IHADJADENE

CONTACT

01 58 41 33 82; karima.mesbahi@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: April 23, 2025
• Study Start: December 19, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)