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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
We are doing this study to learn more about anifrolumab (SAPHNELOTM) in patients with systemic sclerosis and to better understand the studied disease and associated health problems. Systemic sclerosis (scleroderma) affects the skin as well as other organs, such as blood vessels, muscles and joints, digestive tract, kidneys, lungs and heart.
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• 18 to 70 years old
• diagnosis of systemic sclerosis within 6 years from first non-Raynaud's symptoms
• skin at injections sites is without symptoms
• see link to clinicaltrials.gov for complete inclusion and exclusion criteria
Exclusion Criteria:
• severe heart or lung disease
• history of any other inflammatory diseases
• history of hematopoietic stem cell transplantation or solid organ or limb transplantation
• current or a history of cancer within past 5 years
• active current or history of reoccurring infections
Interventions:
Combination Product: Anifrolumab (blinded), Combination Product: Anifrolumab (unblinded, open label), Drug: Placebo (blinded)
Conditions:
Arthritis & Rheumatic Diseases
Keywords:
Clinics and Surgery Center (CSC), systemic sclerosis, Scleroderma
Study Contact: Katherine Wu - wuxx1320@umn.edu
Principal Investigator: Jerry Molitor
Phase: PHASE3
IRB Number: STUDY00019243
See this study on ClinicalTrials.gov