Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
Not Applicable
Not yet recruiting
- Conditions
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
- Interventions
- Drug: Placebo
- Registration Number
- NCT07160608
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 75
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tarperprumig Group 1 Tarperprumig Participants will be administered tarperprumig dose regimen #1 or dose regimen #2. Tarperprumig Group 2 Placebo Participants will be administered tarperprumig dose regimen #1 or dose regimen #2. Tarperprumig Group 2 Tarperprumig Participants will be administered tarperprumig dose regimen #1 or dose regimen #2. Placebo Group 3 Placebo Participants will be administered placebo.
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment-emergent Adverse Events (TEAEs) Baseline through Week 70
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Research Site
🇬🇧Manchester, United Kingdom
Research Site🇬🇧Manchester, United Kingdom