Dosage and formulations of the anti-IL-15 antibody for the treatment of immune diseases

Claims

A monoclonal antibody against IL-15, stable formulations, and specific dosages are described. The antibody is suitable for treating immune disorders in humans, such as celiac disease, vitiligo, alopecia, and atopic dermatitis. The antibody is further characterized by prolonged suppression of serum NK cell and IL-15 levels, suppression of specific disease-related cell types, and the absence of serious adverse effects.

1. An aqueous pharmaceutical formulation comprising: (a) about 100 mg / mL to about 150 mg / mL of an antibody that specifically binds to human IL-15, wherein the antibody or antigen-binding fragment thereof comprises: a heavy chain variable region complementarity-determining region (CDR) 1 comprising the amino acid sequence of SEQ ID No. 1, a heavy chain variable region CDR2 comprising the amino acid sequence of SEQ ID No. 2, a heavy chain variable region CDR3 comprising the amino acid sequence of SEQ ID No. 3, a light chain variable region CDR1 comprising the amino acid sequence of SEQ ID No. 4, a light chain variable region CDR2 comprising the amino acid sequence of SEQ ID No. 5, and a light chain variable region CDR3 comprising the amino acid sequence of SEQ ID No. 6; and (b) one or more pharmaceutically acceptable excipients.