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Tarperprumig for adults with ANCA-associated vasculitis

Phase 2, Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (I TRANSCEND)

Phase 2 Interventional Alexion Pharmaceuticals, Inc. · NCT07160608

This phase 2 trial will test whether tarperprumig is safe and tolerable in adults with newly diagnosed or relapsing ANCA-associated vasculitis who are PR3- or MPO-ANCA positive.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment75 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorAlexion Pharmaceuticals, Inc. Industry-sponsored
Drugs / interventionsrituximab, cyclophosphamide
Locations78 sites (Ciudad de Buenos Aires and 77 other locations)
Trial IDNCT07160608 on ClinicalTrials.gov

What this trial studies

This is a phase 2 interventional trial in which eligible adults with newly diagnosed or relapsing ANCA-associated vasculitis will receive either tarperprumig or a placebo and be followed for safety and tolerability outcomes. Participants must be PR3-ANCA or MPO-ANCA positive and meet BVAS criteria for disease activity, and are those for whom rituximab or cyclophosphamide is being considered. Safety monitoring will include adverse event reporting and clinical assessments over the scheduled follow-up period. The trial is being conducted at research sites in and around Buenos Aires, Argentina.

Who should consider this trial

Good fit: Adults with newly diagnosed or relapsing granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) who are PR3- or MPO-ANCA positive and meet the BVAS criteria, and for whom rituximab or cyclophosphamide would be considered, are ideal candidates.

Not a fit: Patients with other primary systemic autoimmune diseases listed in the exclusion criteria (for example EGPA, SLE, IgA nephropathy) or those with severe pulmonary hemorrhage or other conditions that make them ineligible are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, tarperprumig could become an additional treatment option that is safe and better tolerated for some patients with ANCA-associated vasculitis.

How similar studies have performed: While established therapies like rituximab and cyclophosphamide have proven effectiveness in ANCA vasculitis, tarperprumig is a novel investigational agent with limited prior clinical data in this condition.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Ciudad de Buenos Aires and 77 other locations

+28 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Anti-Neutrophil Cytoplasmic Antibody-Associated VasculitisANCA-associated vasculitisVasculitisIMP
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.