Recruiting
Phase 2

Tarperprumig

Sponsor:

Alexion Pharmaceuticals, Inc.

Code:

NCT07160608

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Placebo

Tarperprumig

Study Details

Brief 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.

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Study ID

NCT07160608

Start date

Nov 26, 2025

Status verified date

Jun, 2026

Completion date

Feb 14, 2028

Anticipated

Primary completion date

Oct 11, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tarperprumig Group 1

Participants will be administered tarperprumig dose regimen #1 or dose regimen #2.

experimental: Tarperprumig Group 2

Participants will be administered tarperprumig dose regimen #1 or dose regimen #2.

experimental: Placebo Group 3

Participants will be administered placebo.

Interventions

Placebo

Participants will receive placebo.

Tarperprumig

Participants will receive tarperprumig.

Primary outcome measure

  • Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Baseline through Week 70 ]

Central Contacts and Locations

Central contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

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

Locations

Research Site

Recruiting

Calgary, Alberta, Canada, T2N 1N4

Research Site

Recruiting

Edmonton, Alberta, Canada, T6G 2X8

Research Site

Recruiting

Etobicoke, Ontario, Canada, M9W 6V1

Research Site

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Research Site

Recruiting

Toronto, Ontario, Canada, M5T 3L9

Research Site

Recruiting

Montreal, Quebec, Canada, H4J 1C5

More Information

Sponsor

Alexion Pharmaceuticals, Inc.

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • ANCA-associated vasculitis
  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
  • Vasculitis
  • IMP (Tarperprumig)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc. on 2026-06-16.