RecruitingPhase 2

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

Argentina, Australia, Brazil75 participantsStarted 2025-11-26

Plain-language 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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 2 trial primarily measuring how many people experience treatment-related side effects from tarperprumig, what does that mean about how much is still unknown regarding its safety profile compared to my current treatment options for ANCA-associated vasculitis?
2ANCA-associated vasculitis can affect different organs in different ways — given my specific type and severity of ANCA vasculitis, do you think I would be a realistic candidate worth exploring for this trial, or would standard therapies like rituximab or cyclophosphamide be a more established path for me right now?
3Because this trial is actively recruiting, are there strict eligibility requirements — like specific ANCA antibody types, kidney function levels, or prior treatments — that would determine whether I could even be considered for participation?
4If I enrolled and experienced a treatment-emergent adverse event, what would that process look like — would I be able to stop the trial treatment and switch to a proven therapy without losing access to my usual care?
5How does tarperprumig work differently from the standard treatments for ANCA-associated vasculitis, and is there anything known from earlier research stages about why it might be worth trying in a Phase 2 study like this one?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Treatment-emergent Adverse Events (TEAEs)

Timeframe: Baseline through Week 70

Trial details

NCT IDNCT07160608

SponsorAlexion Pharmaceuticals, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-11

Contact for this trial

Alexion Pharmaceuticals, Inc. (Sponsor)

1-855-752-2356 clinicaltrials@alexion.com

View on ClinicalTrials.gov More Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.