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

Last updated: June 15, 2026
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Lupus

Dermatomyositis (Connective Tissue Disease)

Collagen Vascular Diseases

Treatment

Placebo

Tarperprumig

Clinical Study ID

NCT07160608
D6722C00001
ALXN1820-ANCA-201
2025-521706-17-00
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosed or relapsing ANCA-associated vasculitis, GPA and MPA subtypesconsistent with the 2022 ACR/EULAR classification criteria for GPA and MPA for whomtreatment with rituximab or cyclophosphamide is considered.

  • Positive test for antibodies to either PR3-ANCA or MPO-ANCA at Screening or in thepast 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 theBVAS.

Exclusion

Exclusion Criteria:

  • Other systemic diseases that, in the judgment of the Investigator, constitute theprimary illness, including but not limited to: eosinophilic granulomatosis withpolyangiitis (EGPA), systemic lupus erythematosus, IgA nephropathy and/or IgAassociated vasculitis with or without Henoch-Schonlein purpura, rheumatoidvasculitis, 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 asubstantial clinical risk to participate in this study.

  • For patients with a previous diagnosis of CKD, patients known to have a stable eGFRfor greater than 3 months prior to Screening and a decline less than 25% of previouseGFR at Screening will be excluded.

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 26, 2025
Estimated Completion Date:
February 14, 2028

Connect with a study center

  • Research Site

    Ciudad de Buenos Aires, C1015ABO
    Argentina

    Active - Recruiting

  • Research Site

    La Plata, B1900AXI
    Argentina

    Active - Recruiting

  • Research Site

    Rosario, S2000DEJ
    Argentina

    Active - Recruiting

  • Research Site

    San Juan Bautista, 1888
    Argentina

    Active - Recruiting

  • Research Site

    Santa Fe, S3000
    Argentina

    Site Not Available

  • Research Site

    Clayton, 3168
    Australia

    Active - Recruiting

  • Research Site

    Heidelberg, 3084
    Australia

    Active - Recruiting

  • Research Site

    Nedlands, 6009
    Australia

    Active - Recruiting

  • Research Site

    Wollongong, 2500
    Australia

    Active - Recruiting

  • Research Site

    Barretos, 14784-057
    Brazil

    Active - Recruiting

  • Research Site

    Belo Horizonte, 30130-100
    Brazil

    Active - Recruiting

  • Research Site

    Porto Alegre, 90035-903
    Brazil

    Active - Recruiting

  • Research Site

    Recife, 50670-420
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo, 01323-001
    Brazil

    Active - Recruiting

  • Research Site

    São Paulo 3448439, 01323-001
    Brazil

    Active - Recruiting

  • Research Site

    Calgary, Alberta T2N 1N4
    Canada

    Active - Recruiting

  • Research Site

    Edmonton, Alberta T6G 2X8
    Canada

    Active - Recruiting

  • Research Site

    Etobicoke, Ontario M9W 6V1
    Canada

    Active - Recruiting

  • Research Site

    Hamilton, Ontario L8N 4A6
    Canada

    Active - Recruiting

  • Research Site

    Toronto, Ontario M5T 3L9
    Canada

    Active - Recruiting

  • Research Site

    Montreal, Quebec H4J 1C5
    Canada

    Active - Recruiting

  • Research Site

    Baotou, 014010
    China

    Active - Recruiting

  • Research Site

    Beijing, 100730
    China

    Active - Recruiting

  • Research Site

    Beijing 1816670, 100034
    China

    Site Not Available

  • Research Site

    Guangzhou, 510080
    China

    Active - Recruiting

  • Research Site

    Hangzhou, 310003
    China

    Active - Recruiting

  • Research Site

    Nanchang, 330006
    China

    Active - Recruiting

  • Research Site

    Shenzhen, 518036
    China

    Active - Recruiting

  • Research Site

    Marseille, 13385
    France

    Active - Recruiting

  • Research Site

    Paris, 75014
    France

    Active - Recruiting

  • Research Site

    Paris 2988507, 75015
    France

    Active - Recruiting

  • Research Site

    Strasbourg, 67091
    France

    Active - Recruiting

  • Research Site

    Toulouse, 31059
    France

    Active - Recruiting

  • Research Site

    Berlin, 10117
    Germany

    Active - Recruiting

  • Research Site

    Essen, 45147
    Germany

    Active - Recruiting

  • Research Site

    Göttingen, 37075
    Germany

    Active - Recruiting

  • Research Site

    Ludwigshafen, 67063
    Germany

    Active - Recruiting

  • Research Site

    München, 81377
    Germany

    Active - Recruiting

  • Research Site

    Brescia, 25123
    Italy

    Active - Recruiting

  • Research Site

    Padova, 35128
    Italy

    Active - Recruiting

  • Research Site

    Pavia, 27100
    Italy

    Active - Recruiting

  • Research Site

    Pisa, 56126
    Italy

    Active - Recruiting

  • Research Site

    Gdansk, 80-214
    Poland

    Active - Recruiting

  • Research Site

    Krakow, 30-688
    Poland

    Active - Recruiting

  • Research Site

    Poznan, 60-355
    Poland

    Active - Recruiting

  • Research Site

    Warsaw, 04-141
    Poland

    Active - Recruiting

  • Research Site

    Daegu, 41944
    South Korea

    Site Not Available

  • Research Site

    Daegu 1835329, 42472
    South Korea

    Active - Recruiting

  • Research Site

    Daejeon, 35015
    South Korea

    Active - Recruiting

  • Research Site

    Seoul, 03080
    South Korea

    Active - Recruiting

  • Research Site

    Seoul 1835848, 04763
    South Korea

    Active - Recruiting

  • Research Site

    Wŏnju, 26426
    South Korea

    Active - Recruiting

  • Research Site

    Barcelona, 08036
    Spain

    Active - Recruiting

  • Research Site

    Pamplona, 31008
    Spain

    Active - Recruiting

  • Research Site

    San Sebastián de los Reyes, 28702
    Spain

    Active - Recruiting

  • Research Site

    Santander, 39008
    Spain

    Active - Recruiting

  • Research Site

    Seville, 41013
    Spain

    Active - Recruiting

  • Research Site

    Kaohsiung City, 81362
    Taiwan

    Active - Recruiting

  • Research Site

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • Research Site

    Taipei, 114
    Taiwan

    Active - Recruiting

  • Research Site

    Taoyuan, 333
    Taiwan

    Active - Recruiting

  • Research Site

    Altındağ, 06230
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Ankara, 5000
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Center, 23200
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Istanbul, 34098
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Istanbul 745044,
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Kocaeli, 41380
    Turkey (Türkiye)

    Active - Recruiting

  • Research Site

    Birmingham, B15 2GW
    United Kingdom

    Active - Recruiting

  • Research Site

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Research Site

    Leicester, LE5 4PW
    United Kingdom

    Active - Recruiting

  • Research Site

    London, NW3 2QG
    United Kingdom

    Active - Recruiting

  • Research Site

    London 2643743, W12 0HS
    United Kingdom

    Site Not Available

  • Research Site

    Manchester, M13 9WL
    United Kingdom

    Active - Recruiting

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