Status:
RECRUITING
Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 9 2028
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT07160608
Start Date
November 26 2025
End Date
February 9 2028
Last Update
January 7 2026
Active Locations (78)
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1
Research Site
Ciudad de Buenos Aires, Argentina, C1015ABO
2
Research Site
Ciudad de Buenos Aires, Argentina, C1181ACH
3
Research Site
La Plata, Argentina, B1900AXI
4
Research Site
Rosario, Argentina, S2000DEJ