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

Last updated: November 4, 2025
Sponsor: Alexion Pharmaceuticals, Inc.
Overall Status: Active - Recruiting

Phase

2

Condition

Vascular Diseases

Dermatomyositis (Connective Tissue Disease)

Lupus

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:
October 31, 2025
Estimated Completion Date:
February 14, 2028

Connect with a study center

  • Research Site

    Ciudad de Buenos Aires, C1181ACH
    Argentina

    Site Not Available

  • Research Site

    La Plata 3432043, B1900AXI
    Argentina

    Site Not Available

  • Research Site

    Rosario 3838583, S2000DEJ
    Argentina

    Site Not Available

  • Research Site

    San Juan Bautista 3433923, 1888
    Argentina

    Site Not Available

  • Research Site

    Santa Fe 3836277, S3000
    Argentina

    Site Not Available

  • Research Site

    Clayton 2171400, 3168
    Australia

    Site Not Available

  • Research Site

    Heidelberg 2163654, 3084
    Australia

    Site Not Available

  • Research Site

    Nedlands 2064874, 6009
    Australia

    Site Not Available

  • Research Site

    Barretos 3470451, 14784-057
    Brazil

    Site Not Available

  • Research Site

    Belo Horizonte 3470127, 30130-100
    Brazil

    Site Not Available

  • Research Site

    Porto Alegre 3452925, 90035-903
    Brazil

    Site Not Available

  • Research Site

    Recife 3390760, 50670-420
    Brazil

    Site Not Available

  • Research Site

    São Paulo 3448439, 01323-001
    Brazil

    Site Not Available

  • Research Site

    Calgary 5913490, Alberta 5883102 T2N 1N4
    Canada

    Site Not Available

  • Research Site

    Edmonton 5946768, Alberta 5883102 T6G 2X8
    Canada

    Site Not Available

  • Research Site

    Etobicoke 5950268, Ontario 6093943 M9W 6V1
    Canada

    Active - Recruiting

  • Research Site

    Hamilton 5969782, Ontario 6093943 L8N 4A6
    Canada

    Site Not Available

  • Research Site

    Toronto 6167865, Ontario 6093943 M5T 3L9
    Canada

    Site Not Available

  • Research Site

    Montreal 6077243, Quebec 6115047 H4J 1C5
    Canada

    Site Not Available

  • Research Site

    Baotou 2038432, 014010
    China

    Site Not Available

  • Research Site

    Beijing 1816670, 100730
    China

    Site Not Available

  • Research Site

    Guangzhou 1809858, 510080
    China

    Site Not Available

  • Research Site

    Hangzhou 1808926, 310003
    China

    Site Not Available

  • Research Site

    Nanchang 1800163, 330006
    China

    Site Not Available

  • Research Site

    Shenzhen 1795565, 518036
    China

    Site Not Available

  • Research Site

    Marseille 2995469, 13385
    France

    Site Not Available

  • Research Site

    Paris 2988507, 75015
    France

    Site Not Available

  • Research Site

    Strasbourg 2973783, 67091
    France

    Site Not Available

  • Research Site

    Toulouse 2972315, 31059
    France

    Site Not Available

  • Research Site

    Berlin 2950159, 10117
    Germany

    Site Not Available

  • Research Site

    Essen 2928810, 45147
    Germany

    Site Not Available

  • Research Site

    Göttingen 2918632, 37075
    Germany

    Site Not Available

  • Research Site

    Ludwigshafen 2875377, 67063
    Germany

    Site Not Available

  • Research Site

    München 2867711, 81377
    Germany

    Site Not Available

  • Research Site

    Brescia 3181554, 25123
    Italy

    Site Not Available

  • Research Site

    Padua 3171728, 35128
    Italy

    Site Not Available

  • Research Site

    Pavia 3171366, 27100
    Italy

    Site Not Available

  • Research Site

    Pisa 3170647, 56126
    Italy

    Site Not Available

  • Research Site

    Gdansk 3099434, 80-214
    Poland

    Site Not Available

  • Research Site

    Krakow 3094802, 30-688
    Poland

    Site Not Available

  • Research Site

    Poznan 3088171, 60-355
    Poland

    Site Not Available

  • Research Site

    Warsaw 756135, 04-141
    Poland

    Site Not Available

  • Research Site

    Daegu 1835329, 41944
    South Korea

    Site Not Available

  • Research Site

    Daejeon 1835235, 35015
    South Korea

    Site Not Available

  • Research Site

    Seoul 1835848, 135-710
    South Korea

    Site Not Available

  • Research Site

    Wŏnju 1833105, 26426
    South Korea

    Site Not Available

  • Research Site

    Barcelona 3128760, 08036
    Spain

    Site Not Available

  • Research Site

    Pamplona 3114472, 31008
    Spain

    Site Not Available

  • Research Site

    San Sebastián de los Reyes 3110040, 28702
    Spain

    Site Not Available

  • Research Site

    Santander 3109718, 39008
    Spain

    Site Not Available

  • Research Site

    Seville 2510911, 41013
    Spain

    Site Not Available

  • Research Site

    Kaohsiung City 1673820, 81362
    Taiwan

    Site Not Available

  • Research Site

    Taichung 1668399, 40705
    Taiwan

    Site Not Available

  • Research Site

    Taipei 1668341, 114
    Taiwan

    Site Not Available

  • Research Site

    Taoyuan District 1667905, 333
    Taiwan

    Site Not Available

  • Research Site

    Altındağ 323935, 06230
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Ankara 323786, 5000
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Istanbul 745044, 34098
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Kocaeli 306970, 41380
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Merkez 388147, 23200
    Turkey (Türkiye)

    Site Not Available

  • Research Site

    Birmingham 2655603, B15 2GW
    United Kingdom

    Site Not Available

  • Research Site

    Cambridge 2653941, CB2 0QQ
    United Kingdom

    Site Not Available

  • Research Site

    Leicester 2644668, LE5 4PW
    United Kingdom

    Site Not Available

  • Research Site

    London 2643743, W12 0HS
    United Kingdom

    Site Not Available

  • Research Site

    Manchester 2643123, M13 9WL
    United Kingdom

    Site Not Available

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