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

NCT07160608 | Recruiting Phase 2 DMC FDA Drug

• 3 other identifiers: D6722C000012025-521706-17-00ALXN1820-ANCA-201
• Study Type: interventional
• Target: 75
• Locations: 14 countries
• Sites: 78

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-emergent Adverse Events (TEAEs)

  Baseline through Week 70

Secondary Outcomes (12)

• Number of Participants Achieving Disease Remission at Week 26

  Week 26

• Number of Participants Achieving Sustained Remission at Week 52

  Week 52

• Number of Participants Achieving a Birmingham Vasculitis Activity Score (BVAS) of 0

  Baseline through Week 52

• Number of Participants Experiencing a Relapse After Previously Achieving Disease Remission at Week 26

  Week 26 through Week 70

• Time to First Relapse After Having Achieved Disease Remission at Week 26

  Week 26 through Week 70

Study Arms (3)

Tarperprumig Group 1

EXPERIMENTAL

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

Drug: Tarperprumig

Tarperprumig Group 2

EXPERIMENTAL

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

Drug: Placebo; Drug: Tarperprumig

Placebo Group 3

EXPERIMENTAL

Participants will be administered placebo.

Drug: Placebo

Interventions

Placebo DRUG

Participants will receive placebo.

Placebo Group 3; Tarperprumig Group 2

Tarperprumig DRUG

Participants will receive tarperprumig.

Also known as: ALXN1820

Tarperprumig Group 1; Tarperprumig Group 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead

Study Sites (78)

Research Site

Ciudad de Buenos Aires, C1015ABO, Argentina

RECRUITING

Research Site

Ciudad de Buenos Aires, C1181ACH, Argentina

RECRUITING

Research Site

La Plata, B1900AXI, Argentina

RECRUITING

Research Site

Rosario, S2000DEJ, Argentina

RECRUITING

Research Site

San Juan Bautista, 1888, Argentina

RECRUITING

Research Site

Santa Fe, S3000, Argentina

WITHDRAWN

Research Site

Clayton, 3168, Australia

NOT YET RECRUITING

Research Site

Heidelberg, 3084, Australia

NOT YET RECRUITING

Research Site

Nedlands, 6009, Australia

NOT YET RECRUITING

Research Site

Wollongong, 2500, Australia

NOT YET RECRUITING

Research Site

Barretos, 14784-057, Brazil

RECRUITING

Research Site

Belo Horizonte, 30130-100, Brazil

RECRUITING

Research Site

Porto Alegre, 90035-903, Brazil

NOT YET RECRUITING

Research Site

Recife, 50670-420, Brazil

NOT YET RECRUITING

Research Site

São Paulo, 01323-001, Brazil

RECRUITING

Research Site

São Paulo, 04038-031, Brazil

NOT YET RECRUITING

Research Site

São Paulo, 05430-010, Brazil

RECRUITING

Research Site

Calgary, Alberta, T2N 1N4, Canada

NOT YET RECRUITING

Research Site

Edmonton, Alberta, T6G 2X8, Canada

RECRUITING

Research Site

Etobicoke, Ontario, M9W 6V1, Canada

RECRUITING

Research Site

Hamilton, Ontario, L8N 4A6, Canada

NOT YET RECRUITING

Research Site

Toronto, Ontario, M5T 3L9, Canada

NOT YET RECRUITING

Research Site

Montreal, Quebec, H4J 1C5, Canada

NOT YET RECRUITING

Research Site

Baotou, 014010, China

NOT YET RECRUITING

Research Site

Beijing, 100034, China

NOT YET RECRUITING

Research Site

Beijing, 100730, China

NOT YET RECRUITING

Research Site

Guangzhou, 510080, China

NOT YET RECRUITING

Research Site

Hangzhou, 310003, China

NOT YET RECRUITING

Research Site

Nanchang, 330006, China

NOT YET RECRUITING

Research Site

Shenzhen, 518036, China

NOT YET RECRUITING

Research Site

Marseille, 13385, France

RECRUITING

Research Site

Paris, 75014, France

RECRUITING

Research Site

Paris, 75015, France

RECRUITING

Research Site

Strasbourg, 67091, France

RECRUITING

Research Site

Toulouse, 31059, France

RECRUITING

Research Site

Berlin, 10117, Germany

RECRUITING

Research Site

Essen, 45147, Germany

RECRUITING

Research Site

Göttingen, 37075, Germany

RECRUITING

Research Site

Ludwigshafen, 67063, Germany

RECRUITING

Research Site

München, 81377, Germany

RECRUITING

Research Site

Brescia, 25123, Italy

RECRUITING

Research Site

Padua, 35128, Italy

RECRUITING

Research Site

Pavia, 27100, Italy

RECRUITING

Research Site

Pisa, 56126, Italy

RECRUITING

Research Site

Gdansk, 80-214, Poland

RECRUITING

Research Site

Krakow, 30-688, Poland

RECRUITING

Research Site

Poznan, 60-355, Poland

RECRUITING

Research Site

Warsaw, 04-141, Poland

NOT YET RECRUITING

Research Site

Daegu, 41944, South Korea

WITHDRAWN

Research Site

Daegu, 42472, South Korea

RECRUITING

Research Site

Daejeon, 35015, South Korea

RECRUITING

Research Site

Seoul, 03080, South Korea

RECRUITING

Research Site

Seoul, 03722, South Korea

RECRUITING

Research Site

Seoul, 04763, South Korea

RECRUITING

Research Site

Seoul, 08308, South Korea

RECRUITING

Research Site

Seoul, 135-710, South Korea

RECRUITING

Research Site

Wŏnju, 26426, South Korea

RECRUITING

Research Site

Barcelona, 08036, Spain

RECRUITING

Research Site

Pamplona, 31008, Spain

RECRUITING

Research Site

San Sebastián de los Reyes, 28702, Spain

RECRUITING

Research Site

Santander, 39008, Spain

RECRUITING

Research Site

Seville, 41013, Spain

RECRUITING

Research Site

Kaohsiung City, 81362, Taiwan

RECRUITING

Research Site

Taichung, 40705, Taiwan

RECRUITING

Research Site

Taipei, 114, Taiwan

RECRUITING

Research Site

Taoyuan District, 333, Taiwan

RECRUITING

Research Site

Altındağ, 06230, Turkey (Türkiye)

RECRUITING

Research Site

Ankara, 5000, Turkey (Türkiye)

RECRUITING

Research Site

Center, 23200, Turkey (Türkiye)

RECRUITING

Research Site

Istanbul, 34098, Turkey (Türkiye)

RECRUITING

Research Site

Istanbul, Turkey (Türkiye)

RECRUITING

Research Site

Kocaeli, 41380, Turkey (Türkiye)

RECRUITING

Research Site

Birmingham, B15 2GW, United Kingdom

NOT YET RECRUITING

Research Site

Cambridge, CB2 0QQ, United Kingdom

NOT YET RECRUITING

Research Site

Leicester, LE5 4PW, United Kingdom

NOT YET RECRUITING

Research Site

London, NW3 2QG, United Kingdom

NOT YET RECRUITING

Research Site

London, W12 0HS, United Kingdom

NOT YET RECRUITING

Research Site

Manchester, M13 9WL, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Vasculitis

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: September 8, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): October 11, 2027
• Study Completion (Estimated): February 14, 2028
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

CA (6); DE (5); PL (4); CN (7); FR (5); IT (4); TU (6); ES (5); KR (9); AR (6); BR (7); AU (4); TW (4); GB (6)