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Clinical Trials in the UK / NCT07160608
Recruiting Phase 2

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

NCT07160608 · tracked via the Priya Life Science UK tracker
Sponsor
Alexion Pharmaceuticals, Inc.
Phase
Phase 2
Started
2025-11-26
Last updated
2026-06-16

Condition(s) studied

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Investigational drug(s) / intervention(s)

PlaceboTarperprumig

Placebo: Participants will receive placebo.

Tarperprumig: Participants will receive tarperprumig.

Study 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 vasculitis.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (78)

FacilityCityRegionStatus
Research Site Ciudad de Buenos Aires Argentina Recruiting
Research Site Ciudad de Buenos Aires Argentina Recruiting
Research Site La Plata Argentina Recruiting
Research Site Rosario Argentina Recruiting
Research Site San Juan Bautista Argentina Recruiting
Research Site Santa Fe Argentina Withdrawn
Research Site Clayton Australia Recruiting
Research Site Heidelberg Australia Recruiting
Research Site Nedlands Australia Recruiting
Research Site Wollongong Australia Recruiting
Research Site Barretos Brazil Recruiting
Research Site Belo Horizonte Brazil Recruiting
Research Site Porto Alegre Brazil Recruiting
Research Site Recife Brazil Recruiting
Research Site São Paulo Brazil Recruiting
Research Site São Paulo Brazil Recruiting
Research Site São Paulo Brazil Recruiting
Research Site Calgary Alberta Recruiting
Research Site Edmonton Alberta Recruiting
Research Site Etobicoke Ontario Recruiting
Research Site Hamilton Ontario Recruiting
Research Site Toronto Ontario Recruiting
Research Site Montreal Quebec Recruiting
Research Site Baotou China Recruiting
Research Site Beijing China Recruiting
Research Site Beijing China Recruiting
Research Site Guangzhou China Recruiting
Research Site Hangzhou China Recruiting
Research Site Nanchang China Recruiting
Research Site Shenzhen China Recruiting
Research Site Marseille France Recruiting
Research Site Paris France Recruiting
Research Site Paris France Recruiting
Research Site Strasbourg France Recruiting
Research Site Toulouse France Recruiting
Research Site Berlin Germany Recruiting
Research Site Essen Germany Recruiting
Research Site Göttingen Germany Recruiting
Research Site Ludwigshafen Germany Recruiting
Research Site München Germany Recruiting

+ 38 more sites — see the full list on the official registry below.

More Alexion Pharmaceuticals, Inc. trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07160608 on ClinicalTrials.gov ↗ ← All trials in the UK