Study identifier:D3460C00002
ClinicalTrials.gov identifier:NCT05925803
EudraCT identifier:N/A
CTIS identifier:2022-502142-26-00
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
Systemic Sclerosis, Scleroderma
Phase 3
No
Anifrolumab (blinded), Placebo (blinded), Anifrolumab (unblinded, open label)
All
306
Interventional
18 Years - 70 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Anifrolumab (subcutaneous weekly injection) Anifrolumab subcutaneous injection once weekly | Combination Product: Anifrolumab (blinded) Anifrolumab treatment delivered subcutaneously, once weekly for 52 weeks Other Name: Treatment arm (blinded) Combination Product: Anifrolumab (unblinded, open label) At Week 52, all patients will receive Anifrolumab subcutaneously once weekly for 52 weeks Other Name: Treatment arm (not blinded) |
Placebo Comparator: matched placebo control (subcutaneous weekly injection) matched placebo control subcutaneous injection once weekly | Drug: Placebo (blinded) matched placebo delivered subcutaneously, once weekly for 52 weeks Other Name: Placebo arm (blinded) |