Safety and tolerability of an anti-CD19 monoclonal antibody, MEDI-551, in subjects with systemic sclerosis: a phase I, randomized, placebo-controlled, escalating single-dose study

• Published in: Arthritis research & therapy Vol. 18; no. 1; p. 131
• Main Authors: Schiopu, Elena, Chatterjee, Soumya, Hsu, Vivien, Flor, Armando, Cimbora, Daniel, Patra, Kaushik, Yao, Wenliang, Li, Jing, Streicher, Katie, McKeever, Kathleen, White, Barbara, Katz, Eliezer, Drappa, Jorn, Sweeny, Sarah, Herbst, Ronald
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 07.06.2016; BioMed Central
• Subjects: Adult; Aged; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - pharmacokinetics; Antibodies, Monoclonal, Humanized - administration & dosage; Antibodies, Monoclonal, Humanized - adverse effects; Antibodies, Monoclonal, Humanized - pharmacokinetics; Antigens, CD19; Area Under Curve; Arthritis; B cells; Dosage and administration; Dose-Response Relationship, Drug; Double-Blind Method; Drug therapy; Enzyme-Linked Immunosorbent Assay; Female; Flow Cytometry; Health aspects; Humans; Male; Middle Aged; Monoclonal antibodies; ROC Curve; Scleroderma (Disease); Scleroderma, Systemic - drug therapy; Sclerosis; Systemic scleroderma; United States; Pharmacodynamics; B cells; Pharmacokinetics; Scleroderma; CD19; Systemic sclerosis

Systemic sclerosis (SSc) is a clinically heterogeneous, life-threatening disease characterized by fibrosis, microvasculopathy, and autoimmunity. Extensive nonclinical and clinical data implicate B cells in the pathogenesis of SSc. MEDI-551 is an investigational humanized monoclonal antibody that tar...