Recruiting NCT07160608

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

Phase II Interventional Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Placebo, Tarperprumig.
Who it may be relevant to: Registry conditions: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis. Basic parameters: 18 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Argentina, Australia, Brazil, Canada, China +9
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Phase 2, Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis (I TRANSCEND)

Overview

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.

Interventions

Drug Placebo
Participants will receive placebo.
Drug Tarperprumig
Participants will receive tarperprumig.

Primary outcome measures

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

Secondary outcome measures (12)

Number of Participants Achieving Disease Remission at Week 26 [Time frame: Week 26]
Number of Participants Achieving Sustained Remission at Week 52 [Time frame: Week 52]
Number of Participants Achieving a Birmingham Vasculitis Activity Score (BVAS) of 0 [Time frame: Baseline through Week 52]
Number of Participants Experiencing a Relapse After Previously Achieving Disease Remission at Week 26 [Time frame: Week 26 through Week 70]
Time to First Relapse After Having Achieved Disease Remission at Week 26 [Time frame: Week 26 through Week 70]
Change from Baseline in Vasculitis Damage Index [Time frame: Baseline, Weeks 26, and 52]
Time to First Occurrence of BVAS of 0 [Time frame: Baseline through Week 52]
Change from Baseline in BVAS [Time frame: Baseline, Weeks 26, and 52]
Change from Baseline in Estimated Glomerular Filtration Rate [Time frame: Baseline, Weeks 26, and 52]
Change from Baseline in Proteinuria Based on Spot Urine Protein-Creatinine Ratio [Time frame: Baseline, Weeks 26, and 52]
Change from Baseline in Proteinuria Based on Spot Urine Albumin-Creatinine Ratio [Time frame: Baseline, Weeks 26, and 52]
Change from Baseline in Hematuria [Time frame: Baseline, Weeks 26, and 52]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

South Korea · 9 centers

Research Site — Daegu
Research Site — Daegu
Research Site — Daejeon
Research Site — Seoul
Research Site — Seoul
Research Site — Seoul
Research Site — Seoul
Research Site — Seoul
… and 1 more center

Brazil · 7 centers

Research Site — Barretos
Research Site — Belo Horizonte
Research Site — Porto Alegre
Research Site — Recife
Research Site — São Paulo
Research Site — São Paulo
Research Site — São Paulo

China · 7 centers

Research Site — Baotou
Research Site — Beijing
Research Site — Beijing
Research Site — Guangzhou
Research Site — Hangzhou
Research Site — Nanchang
Research Site — Shenzhen

Argentina · 6 centers

Research Site — Ciudad de Buenos Aires
Research Site — Ciudad de Buenos Aires
Research Site — La Plata
Research Site — Rosario
Research Site — San Juan Bautista
Research Site — Santa Fe

Canada · 6 centers

Research Site — Calgary
Research Site — Edmonton
Research Site — Etobicoke
Research Site — Hamilton
Research Site — Toronto
Research Site — Montreal

Turkey (Türkiye) · 6 centers

Research Site — Altındağ
Research Site — Ankara
Research Site — Center
Research Site — Istanbul
Research Site — Istanbul
Research Site — Kocaeli

United Kingdom · 6 centers

Research Site — Birmingham
Research Site — Cambridge
Research Site — Leicester
Research Site — London
Research Site — London
Research Site — Manchester

France · 5 centers

Research Site — Marseille
Research Site — Paris
Research Site — Paris
Research Site — Strasbourg
Research Site — Toulouse

Germany · 5 centers

Research Site — Berlin
Research Site — Essen
Research Site — Göttingen
Research Site — Ludwigshafen
Research Site — München

Spain · 5 centers

Research Site — Barcelona
Research Site — Pamplona
Research Site — San Sebastián de los Reyes
Research Site — Santander
Research Site — Seville

Australia · 4 centers

Research Site — Clayton
Research Site — Heidelberg
Research Site — Nedlands
Research Site — Wollongong

Italy · 4 centers

Research Site — Brescia
Research Site — Padova
Research Site — Pavia
Research Site — Pisa

Poland · 4 centers

Research Site — Gdansk
Research Site — Krakow
Research Site — Poznan
Research Site — Warsaw

Taiwan · 4 centers

Research Site — Kaohsiung City
Research Site — Taichung
Research Site — Taipei
Research Site — Taoyuan

Identifiers

NCT: NCT07160608 · D6722C00001 · 2025-521706-17-00 · ALXN1820-ANCA-201

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗