Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis

Alexion Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Treatments: Drug: Placebo; Drug: Tarperprumig

Study type: Interventional

Funder types: Industry

Identifiers

NCT07160608

ALXN1820-ANCA-201 (Other Identifier)

2025-521706-17-00 (Other Identifier)

D6722C00001

Details and patient eligibility

About

The primary objective of this study is to evaluate the safety and tolerability of tarperprumig in participants with newly diagnosed or relapsing anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newly diagnosed or relapsing ANCA-associated vasculitis, GPA and MPA subtypes consistent with the 2022 ACR/EULAR classification criteria for GPA and MPA for whom treatment with rituximab or cyclophosphamide is considered.
• Positive test for antibodies to either PR3-ANCA or MPO-ANCA at Screening or in the past by a quantitative assay (for example, ELISA, bead assay).
• At least one major item, or at least 3 minor items, or at least 2 renal items in the BVAS.

Exclusion criteria

• Other systemic diseases that, in the judgment of the Investigator, constitute the primary illness, including but not limited to: eosinophilic granulomatosis with polyangiitis (EGPA), systemic lupus erythematosus, IgA nephropathy and/or IgA associated vasculitis with or without Henoch-Schonlein purpura, rheumatoid vasculitis, Sjogren's syndrome, anti-GBM disease, cryoglobulinemic vasculitis, autoimmune hemolytic anemia, or mixed connective tissue disease.
• Alveolar hemorrhage requiring invasive pulmonary ventilation support at Screening.
• Any diseases or conditions that, in the judgment of the Investigator, present a substantial clinical risk to participate in this study.
• For patients with a previous diagnosis of CKD, patients known to have a stable eGFR for greater than 3 months prior to Screening and a decline less than 25% of previous eGFR at Screening will be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 3 patient groups

Tarperprumig Group 1

Experimental group

Description:

Participants will be administered tarperprumig dose regimen #1 or dose regimen #2.

Treatment:

Drug: Tarperprumig

Tarperprumig Group 2

Experimental group

Description:

Participants will be administered tarperprumig dose regimen #1 or dose regimen #2.

Treatment:

Drug: Tarperprumig

Drug: Placebo

Placebo Group 3

Experimental group

Description:

Participants will be administered placebo.

Treatment:

Drug: Placebo