Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
In brief
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.
Key facts
- Study ID
- NCT07160608
- Run by
- Alexion Pharmaceuticals, Inc.
- People needed
- 75
- Starts
- 2025-11-26
- Expected to finish
- 2028-02-14
- Last updated by the study team
- 2026-06-16
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Research Site — Ciudad de Buenos Aires, Argentina (enrolling)
- Research Site — Ciudad de Buenos Aires, Argentina (enrolling)
- Research Site — Rosario, Argentina (enrolling)
- Research Site — San Juan Bautista, Argentina (enrolling)
- Research Site — La Plata, Argentina (enrolling)
- Research Site — Clayton, Australia (enrolling)
- Research Site — Heidelberg, Australia (enrolling)
- Research Site — Nedlands, Australia (enrolling)
- Research Site — Wollongong, Australia (enrolling)
- Research Site — Barretos, Brazil (enrolling)
- Research Site — Belo Horizonte, Brazil (enrolling)
- Research Site — Porto Alegre, Brazil (enrolling)
- Research Site — Recife, Brazil (enrolling)
- Research Site — São Paulo, Brazil (enrolling)
- Research Site — São Paulo, Brazil (enrolling)
- Research Site — São Paulo, Brazil (enrolling)
- Research Site — Calgary, Alberta, Canada (enrolling)
- Research Site — Edmonton, Alberta, Canada (enrolling)
- Research Site — Etobicoke, Ontario, Canada (enrolling)
- Research Site — Hamilton, Ontario, Canada (enrolling)
- Research Site — Toronto, Ontario, Canada (enrolling)
- Research Site — Montreal, Quebec, Canada (enrolling)
- Research Site — Baotou, China (enrolling)
- Research Site — Beijing, China (enrolling)
- Research Site — Beijing, China (enrolling)
Full record on ClinicalTrials.gov
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