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)
Status: Recruiting
Location: See all (78) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Argentina
Research Site
RECRUITING
Ciudad De Buenos Aires
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RECRUITING
Ciudad De Buenos Aires
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RECRUITING
La Plata
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RECRUITING
Rosario
Research Site
RECRUITING
San Juan Bautista
Research Site
WITHDRAWN
Santa Fe
Australia
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NOT_YET_RECRUITING
Clayton
Research Site
RECRUITING
Heidelberg
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RECRUITING
Nedlands
Research Site
RECRUITING
Wollongong
Brazil
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RECRUITING
Barretos
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RECRUITING
Belo Horizonte
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RECRUITING
Porto Alegre
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NOT_YET_RECRUITING
Recife
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RECRUITING
São Paulo
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RECRUITING
São Paulo
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RECRUITING
São Paulo
Canada
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NOT_YET_RECRUITING
Calgary
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RECRUITING
Edmonton
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RECRUITING
Etobicoke
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NOT_YET_RECRUITING
Hamilton
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NOT_YET_RECRUITING
Montreal
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RECRUITING
Toronto
China
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NOT_YET_RECRUITING
Baotou
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NOT_YET_RECRUITING
Beijing
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RECRUITING
Beijing
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RECRUITING
Guangzhou
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NOT_YET_RECRUITING
Hangzhou
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NOT_YET_RECRUITING
Nanchang
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NOT_YET_RECRUITING
Shenzhen
France
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RECRUITING
Marseille
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RECRUITING
Paris
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RECRUITING
Paris
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RECRUITING
Strasbourg
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RECRUITING
Toulouse
Germany
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RECRUITING
Berlin
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Essen
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RECRUITING
Göttingen
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RECRUITING
Ludwigshafen
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RECRUITING
München
Italy
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RECRUITING
Brescia
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RECRUITING
Padova
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RECRUITING
Pavia
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RECRUITING
Pisa
Poland
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RECRUITING
Gdansk
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RECRUITING
Krakow
Research Site
RECRUITING
Poznan
Research Site
RECRUITING
Warsaw
Republic of Korea
Research Site
RECRUITING
Daegu
Research Site
WITHDRAWN
Daegu
Research Site
RECRUITING
Daejeon
Research Site
RECRUITING
Seoul
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RECRUITING
Seoul
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RECRUITING
Seoul
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RECRUITING
Seoul
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RECRUITING
Seoul
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RECRUITING
Wŏnju
Spain
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RECRUITING
Barcelona
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RECRUITING
Pamplona
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RECRUITING
San Sebastián De Los Reyes
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RECRUITING
Santander
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RECRUITING
Seville
Taiwan
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RECRUITING
Kaohsiung City
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RECRUITING
Taichung
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RECRUITING
Taipei
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RECRUITING
Taoyuan District
Turkey
Research Site
RECRUITING
Altındağ
Research Site
RECRUITING
Ankara
Research Site
RECRUITING
Center
Research Site
RECRUITING
Istanbul
Research Site
RECRUITING
Istanbul
Research Site
RECRUITING
Kocaeli
United Kingdom
Research Site
RECRUITING
Birmingham
Research Site
RECRUITING
Cambridge
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NOT_YET_RECRUITING
Leicester
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NOT_YET_RECRUITING
London
Research Site
NOT_YET_RECRUITING
London
Research Site
NOT_YET_RECRUITING
Manchester
Contact Information
Primary
Alexion Pharmaceuticals, Inc. (Sponsor)
clinicaltrials@alexion.com
1-855-752-2356
Time Frame
Start Date: 2025-11-26
Estimated Completion Date: 2028-02-14
Participants
Target number of participants: 75
Treatments
Experimental: Tarperprumig Group 1
Participants will be administered tarperprumig dose regimen #1 or dose regimen #2.
Experimental: Tarperprumig Group 2
Participants will be administered tarperprumig dose regimen #1 or dose regimen #2.
Experimental: Placebo Group 3
Participants will be administered placebo.
Related Therapeutic Areas
Sponsors
Leads: Alexion Pharmaceuticals, Inc.