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

NCT ID: NCT07160608

Last Updated: 2026-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-26

Study Completion Date

2028-02-09

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tarperprumig Group 1

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

Group Type EXPERIMENTAL

Tarperprumig

Intervention Type DRUG

Participants will receive tarperprumig.

Tarperprumig Group 2

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

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Participants will receive placebo.

Tarperprumig

Intervention Type DRUG

Participants will receive tarperprumig.

Placebo Group 3

Participants will be administered placebo.

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

Participants will receive placebo.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo

Participants will receive placebo.

Intervention Type DRUG

Tarperprumig

Participants will receive tarperprumig.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ALXN1820

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Research Site

Leicester, , United Kingdom

Site Status NOT_YET_RECRUITING

Research Site

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Research Site

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Research Site

Manchester, , United Kingdom

Site Status NOT_YET_RECRUITING

Research Site

Ciudad de Buenos Aires, , Argentina

Site Status RECRUITING

Research Site

Ciudad de Buenos Aires, , Argentina

Site Status RECRUITING

Research Site

La Plata, , Argentina

Site Status RECRUITING

Research Site

Rosario, , Argentina

Site Status RECRUITING

Research Site

San Juan Bautista, , Argentina

Site Status RECRUITING

Research Site

Santa Fe, , Argentina

Site Status WITHDRAWN

Research Site

Clayton, , Australia

Site Status NOT_YET_RECRUITING

Research Site

Heidelberg, , Australia

Site Status NOT_YET_RECRUITING

Research Site

Nedlands, , Australia

Site Status NOT_YET_RECRUITING

Research Site

Wollongong, , Australia

Site Status NOT_YET_RECRUITING

Research Site

Barretos, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Belo Horizonte, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Porto Alegre, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

Recife, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

São Paulo, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

São Paulo, , Brazil

Site Status NOT_YET_RECRUITING

Research Site

São Paulo, , Brazil

Site Status RECRUITING

Research Site

Calgary, Alberta, Canada

Site Status NOT_YET_RECRUITING

Research Site

Edmonton, Alberta, Canada

Site Status RECRUITING

Research Site

Etobicoke, Ontario, Canada

Site Status RECRUITING

Research Site

Hamilton, Ontario, Canada

Site Status NOT_YET_RECRUITING

Research Site

Toronto, Ontario, Canada

Site Status NOT_YET_RECRUITING

Research Site

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Research Site

Baotou, , China

Site Status NOT_YET_RECRUITING

Research Site

Beijing, , China

Site Status NOT_YET_RECRUITING

Research Site

Beijing, , China

Site Status NOT_YET_RECRUITING

Research Site

Guangzhou, , China

Site Status NOT_YET_RECRUITING

Research Site

Hangzhou, , China

Site Status NOT_YET_RECRUITING

Research Site

Nanchang, , China

Site Status NOT_YET_RECRUITING

Research Site

Shenzhen, , China

Site Status NOT_YET_RECRUITING

Research Site

Marseille, , France

Site Status RECRUITING

Research Site

Paris, , France

Site Status RECRUITING

Research Site

Paris, , France

Site Status RECRUITING

Research Site

Strasbourg, , France

Site Status RECRUITING

Research Site

Toulouse, , France

Site Status RECRUITING

Research Site

Berlin, , Germany

Site Status RECRUITING

Research Site

Essen, , Germany

Site Status RECRUITING

Research Site

Göttingen, , Germany

Site Status RECRUITING

Research Site

Ludwigshafen, , Germany

Site Status RECRUITING

Research Site

München, , Germany

Site Status RECRUITING

Research Site

Brescia, , Italy

Site Status RECRUITING

Research Site

Padua, , Italy

Site Status RECRUITING

Research Site

Pavia, , Italy

Site Status RECRUITING

Research Site

Pisa, , Italy

Site Status RECRUITING

Research Site

Gdansk, , Poland

Site Status RECRUITING

Research Site

Krakow, , Poland

Site Status RECRUITING

Research Site

Poznan, , Poland

Site Status RECRUITING

Research Site

Warsaw, , Poland

Site Status NOT_YET_RECRUITING

Research Site

Daegu, , South Korea

Site Status WITHDRAWN

Research Site

Daegu, , South Korea

Site Status RECRUITING

Research Site

Daejeon, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Seoul, , South Korea

Site Status RECRUITING

Research Site

Wŏnju, , South Korea

Site Status RECRUITING

Research Site

Barcelona, , Spain

Site Status RECRUITING

Research Site

Pamplona, , Spain

Site Status RECRUITING

Research Site

San Sebastián de los Reyes, , Spain

Site Status RECRUITING

Research Site

Santander, , Spain

Site Status RECRUITING

Research Site

Seville, , Spain

Site Status RECRUITING

Research Site

Kaohsiung City, , Taiwan

Site Status RECRUITING

Research Site

Taichung, , Taiwan

Site Status RECRUITING

Research Site

Taipei, , Taiwan

Site Status RECRUITING

Research Site

Taoyuan District, , Taiwan

Site Status RECRUITING

Research Site

Altındağ, , Turkey (Türkiye)

Site Status RECRUITING

Research Site

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Research Site

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Research Site

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Research Site

Kocaeli, , Turkey (Türkiye)

Site Status RECRUITING

Research Site

Merkez, , Turkey (Türkiye)

Site Status RECRUITING

Research Site

Birmingham, , United Kingdom

Site Status NOT_YET_RECRUITING

Research Site

Cambridge, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Argentina Australia Brazil Canada China France Germany Italy Poland South Korea Spain Taiwan Turkey (Türkiye) United Kingdom

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Alexion Pharmaceuticals, Inc. (Sponsor)

Role: CONTACT

1-855-752-2356

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2025-521706-17-00

Identifier Type: OTHER

Identifier Source: secondary_id

ALXN1820-ANCA-201

Identifier Type: OTHER

Identifier Source: secondary_id

D6722C00001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

ETA and AT1 Antagonism in ANCA-vasculitis (SPARVASC)
NCT05630612 ACTIVE_NOT_RECRUITING PHASE2
Iptacopan in Patients With ANCA Associated Vasculitis
NCT06388941 ACTIVE_NOT_RECRUITING PHASE2