Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Conditions
Keywords
ANCA-associated vasculitis, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Vasculitis, IMP (Tarperprumig)
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.
Interventions
DRUGPlacebo
Participants will receive placebo.
DRUGTarperprumig
Participants will receive tarperprumig.
Sponsors
Alexion Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Baseline through Week 70 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Change from Baseline in Vasculitis Damage Index | Baseline, Weeks 26, and 52 |
| Time to First Occurrence of BVAS of 0 | Baseline through Week 52 |
| Change from Baseline in BVAS | Baseline, Weeks 26, and 52 |
| Change from Baseline in Estimated Glomerular Filtration Rate | Baseline, Weeks 26, and 52 |
| Change from Baseline in Proteinuria Based on Spot Urine Protein-Creatinine Ratio | Baseline, Weeks 26, and 52 |
| Change from Baseline in Proteinuria Based on Spot Urine Albumin-Creatinine Ratio | Baseline, Weeks 26, and 52 |
| Change from Baseline in Hematuria | Baseline, Weeks 26, and 52 |
Countries
Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Poland, South Korea, Spain, Taiwan, Turkey (Türkiye), United Kingdom
Contacts
CONTACTAlexion Pharmaceuticals, Inc. (Sponsor)
Outcome results
None listed