Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
Study Identifier:
D6722C00001
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
Recruiting
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: Placebo
- Drug: Tarperprumig
Date
Oct 2025 - Oct 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 80 Years
Requirements Information
Inclusion and Exclusion 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.
Sex
Female & Male
Age
18 - 80 Years
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: Placebo
- Drug: Tarperprumig
Date
Oct 2025 - Oct 2027
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 80 Years years
Requirements Information
Inclusion and Exclusion 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.
Protocol 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.
Trial Locations
Location
Status
Location
Research Site
Ciudad de Buenos Aires, Argentina, C1015ABO
Status
Not yet recruiting
Location
Research Site
La Plata, Argentina, B1900AXI
Status
Not yet recruiting
Location
Research Site
Rosario, Argentina, S2000DEJ
Status
Not yet recruiting
Location
Research Site
San Juan Bautista, Argentina, 1888
Status
Not yet recruiting
Location
Research Site
Santa Fe, Argentina, S3000
Status
Withdrawn
Location
Research Site
Clayton, Australia, 3168
Status
Not yet recruiting
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