A Multicenter, Randomized, Parallel-group, Double-blind,Two-arm Phase III Study to Evaluate the Safety and Efficacy of Anifrolumab Compared With Placebo in Male and Female Participants 18 to 70 Years of Age Inclusive With Systemic Sclerosis Status: Recruiting
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Intervention Type: Drug, Combination product
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of treatment with subcutaneous anifrolumab versus placebo in adult participants with systemic sclerosis. The target population for this study includes patients who meet the 2013 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification for systemic sclerosis, either limited or diffuse cutaneous subsets, with a disease duration of less than 6 years from first non-Raynaud's phenomenon symptom.
Participation Requirements View:
Inclusion Criteria
Exclusion Criteria
• Adult patients from 18 to 70 years of age inclusive
• Systemic sclerosis according to 2013 ACR/EULAR classification criteria
• Limited or diffuse cutaneous subsets
• Systemic sclerosis disease duration within 6 years from first non-Raynaud's phenomenon manifestation at the time of signing the ICF
• Either HAQ-DI score ≥ 0.25 points or PtGA score ≥ 3 points
• mRSS \> 10 with early disease or rapid progression as defined by the protocol
• mRSS ≥ 15 with disease duration ≥ 18 months and active disease as defined by the protocol
• Stable background therapies can be used including hydroxychloroquine, methotrexate, azathioprine, mycophenolate mofetil, mycophenolate sodium, mycophenolic acid, oral glucocorticoids or tacrolimus
• Women of childbearing potential with a negative urine pregnancy test
⁃ Uninvolved skin at injection sites
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Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Start Date: 2023-11-08
Estimated Completion Date: 2027-12-31
Target number of participants: 306
Experimental: Anifrolumab (subcutaneous weekly injection)
Anifrolumab subcutaneous injection once weekly
Placebo_comparator: matched placebo control (subcutaneous weekly injection)
matched placebo control subcutaneous injection once weekly