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US 2020/0399384 A1Published application
Method of treating diseases using an il-17 receptor antibody formulation
AssigneeAmgen K-A, Inc.
InventorsDingjiang Liu, Holly Zhuohong Huang, David Andrew Martin, Christopher Boyd Russell, David H. Salinger, Scott Walter Baumgartner, Christopher Endres
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Abstract
The present disclosure relates to AM-14 pharmaceutical formulations and therapeutic dosing regimens for the treatment of disease.
Claims8
-16. (canceled)
A method of treating Sjögren's syndrome, dermatomyositis, or
- systemic lupus erythematosus in a human patient in need thereof, which method comprises administering to the patient an effective amount of a formulation comprising (i) 30 mM glutamic acid, (ii) a pH of 4.8±0.2, (iii) 3±0.2% proline (w/v), (iv) 0.01±0.002% (w/v) polysorbate 20, and (v) a human monoclonal antibody, or an antigen-binding fragment thereof, wherein the human monoclonal antibody comprises:
- (a) a heavy chain CDR1 comprising the amino acid sequence of SEQ ID NO:
- 5, a heavy chain CDR2 comprising the amino acid sequence of SEQ ID NO:
- 7, a heavy chain CDR3 comprising the amino acid sequence of SEQ ID NO:
- 8, and a light chain CDR1 comprising the amino acid sequence of SEQ ID NO:
- 9, a light chain CDR2 comprising the amino acid sequence of SEQ ID NO:
- 10, and a light chain CDR3 comprising the amino acid sequence of SEQ ID NO:
- 11;
- (b) a heavy chain variable domain comprising the amino acid sequence of SEQ ID NO:
- 3 and a light chain variable domain comprising the amino acid sequence of SEQ ID NO:
- 4;
- or
- (c) a heavy chain variable domain comprising the amino acid sequence of SEQ ID NO:
- 1 or SEQ ID NO:
- 12 and a light chain variable domain comprising the amino acid sequence of SEQ ID NO:
- 2;
- wherein the formulation comprises a dose of human monoclonal antibody of about 70 mg, about 140 mg, about 210, or about 280 mg, and whereby the human monoclonal antibody specifically binds to human IL-17 receptor A and inhibits the binding of IL-17A to IL-17 receptor A, and the Sjögren's syndrome, dermatomyositis, or systemic lupus erythematosus is treated in the human patient.
14 more elements
Dependencies are inferred from the claim text.