Method of treating diseases using an il-17 receptor antibody formulation

Abstract

The present disclosure relates to AM-14 pharmaceutical formulations and therapeutic dosing regimens for the treatment of disease.

1 .- 16 . (canceled) 
     
     
         17 . A method of treating scleroderma, sclerosis, multiple sclerosis, or any combination thereof 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 4.5-5.2, (iii) 2-4% proline (w/v), (iv) 0.01±0.002% (w/v) polysorbate 20, and (v) about 140 mg, or about 210 of a human monoclonal antibody, or an antigen-binding fragment thereof that binds to human IL-17 receptor A,
 wherein the human monoclonal antibody comprises: 
 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, and 
 whereby the scleroderma, sclerosis, multiple sclerosis, or any combination thereof is treated in the human patient. 
 
     
     
         18 . The method of  claim 17 , wherein the human monoclonal antibody or an antigen-binding fragment thereof comprises a heavy chain variable domain comprising amino acid sequence of SEQ ID NO: 3 and a light chain variable domain comprising amino acid sequence of SEQ ID NO: 4. 
     
     
         19 . The method of  claim 17 , wherein the human monoclonal antibody comprises a heavy chain amino acid sequence comprising SEQ ID NO: 1 or SEQ ID NO: 12 and a light chain amino acid sequence comprising SEQ ID NO: 2. 
     
     
         20 . The method of  claim 17 , wherein the formulation comprises an osmolarity of 250 to 400 mOsm/L. 
     
     
         21 . The method of  claim 17 , wherein the formulation comprises viscosity of 5 to 7 cP at 25° C. 
     
     
         22 . The method of  claim 17 , wherein the formulation is administered to the patient once a week, once every two weeks, or once every four weeks. 
     
     
         23 . The method of  claim 17 , wherein the formulation is administered to the patient subcutaneously, intradermally, intramuscularly, or intravenously. 
     
     
         24 . The method of  claim 17 , wherein the formulation is administered to the patient over a period of one week to 24 weeks. 
     
     
         25 . The method of  claim 17 , wherein the patient is adult, juvenile, and/or pediatric patients. 
     
     
         26 . The method of  claim 17 , wherein the patient suffers from scleroderma. 
     
     
         27 . The method of  claim 17 , wherein the patient suffers from sclerosis. 
     
     
         28 . The method of  claim 17 , wherein the patient suffers from multiple sclerosis.