Tarperprumig for adults with ANCA-associated vasculitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
  Heidelberg, Australia Recruiting

+28 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
• Email: clinicaltrials@alexion.com
• Phone: 1-855-752-2356

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Anti-CD19/BCMA U CAR-T cell therapy for relapsed or refractory autoimmune diseases

  This pilot will test whether anti-CD19/BCMA U CAR-T cells can help adults with relapsed or refractory autoimmune diseases such as SLE, systemic sclerosis, Sjögren's syndrome, and rheumatoid arthritis.

  Recruiting Early Phase 1 Changhai Hospital · Shanghai · NCT07246096

• YTS109 cell therapy for relapsed or treatment‑resistant autoimmune diseases

  This will try a single infusion of YTS109 immune cells in adults 18–65 with relapsed or treatment‑resistant autoimmune diseases such as lupus, Sjogren’s, systemic sclerosis, inflammatory myopathies, or ANCA‑associated vasculitis.

  Recruiting at 2 sites Phase 1 China Immunotech (Beijing) Biotechnology Co., Ltd. · Xuzhou, Jiangsu and 1 other locations · NCT07236801

• YTS109 cell therapy for relapsed or refractory autoimmune diseases

  This will try a single infusion of YTS109 immune cells to see if they are safe and help adults 18–65 with relapsed or refractory lupus (including lupus nephritis), Sjogren's syndrome, inflammatory myopathy, or ANCA‑associated vasculitis.

  Recruiting Phase 1 China Immunotech (Beijing) Biotechnology Co., Ltd. · Bengbu · NCT07236762

• YTS109 cell therapy for relapsed/refractory autoimmune diseases

  This trial will try a single infusion of YTS109 immune cells to see if they are safe and help adults aged 18–65 with relapsed or refractory autoimmune diseases such as lupus, Sjogren’s syndrome, inflammatory myopathy, or ANCA-associated vasculitis.

  Recruiting Phase 1 China Immunotech (Beijing) Biotechnology Co., Ltd. · Tianjin · NCT07123519

• YTS109 cell therapy for relapsed or refractory autoimmune diseases

  This trial will try a single infusion of YTS109 cells to see if they are safe and help adults (18–65) with relapsing or refractory autoimmune diseases such as SLE, lupus nephritis, systemic sclerosis, inflammatory myopathy, or ANCA-associated vasculitis.

  Recruiting Phase 1 China Immunotech (Beijing) Biotechnology Co., Ltd. · Hefei, Anhui · NCT07104721

• YTS109 cell therapy for relapsed or refractory systemic autoimmune diseases

  This trial will try a single infusion of YTS109 cells to see if it's safe and helps adults 18–65 with relapsed or refractory systemic autoimmune diseases such as SLE, systemic sclerosis, inflammatory myopathies, ANCA-associated vasculitis, or antiphospholipid syndrome.

  Recruiting Phase 1 China Immunotech (Beijing) Biotechnology Co., Ltd. · Beijing, Beijing Municipality · NCT06978647

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.