US 11,723,976 B2
Methods of administering anti-IL31A antibody-containing formulations
Daisuke Kameoka, Tokyo (JP); Toru Yoshizawa, Tokyo (JP); Megumi Numata, Tokyo (JP); Hitoshi Sasaki, Tokyo (JP); So Yamaguchi, Tokyo (JP); Hiroko Murata, Shizuoka (JP); and Naoka Hironiwa, Singapore (SG)
Assigned to Chugai Seiyaku Kabushiki Kaisha, Tokyo (JP)
Filed by Chugai Seiyaku Kabushiki Kaisha, Tokyo (JP)
Filed on Jan. 12, 2022, as Appl. No. 17/573,991.
Application 17/573,991 is a division of application No. 17/346,421, filed on Jun. 14, 2021, granted, now 11,260,125.
Application 17/346,421 is a continuation of application No. 17/058,399, abandoned, previously published as PCT/JP2020/043125, filed on Nov. 19, 2020.
Claims priority of application No. 2019-209851 (JP), filed on Nov. 20, 2019.
Prior Publication US 2022/0125921 A1, Apr. 28, 2022
Int. Cl. C07K 16/28 (2006.01); A61K 39/395 (2006.01); A61K 47/10 (2017.01); A61K 47/18 (2017.01); A61K 47/26 (2006.01); A61K 9/08 (2006.01); A61K 9/19 (2006.01); C07K 14/715 (2006.01); A61K 39/00 (2006.01)
CPC A61K 39/39591 (2013.01) [A61K 9/08 (2013.01); A61K 9/19 (2013.01); A61K 39/3955 (2013.01); A61K 47/10 (2013.01); A61K 47/18 (2013.01); A61K 47/183 (2013.01); A61K 47/26 (2013.01); C07K 16/2866 (2013.01); A61K 2039/505 (2013.01); A61K 2039/54 (2013.01); C07K 14/7155 (2013.01); C07K 2317/56 (2013.01); C07K 2317/565 (2013.01); C07K 2317/76 (2013.01)] 30 Claims
 
1. A method of treating a subject affected with an IL-31-associated disorder, the method comprising administering to the subject by injection or infusion a solution formulation comprising:
6 to 100 mg/mL of an IL-31 antagonist that is an anti-IL-31RA antibody comprising (i) an H chain variable region that comprises a CDR1 as set forth in SEQ ID NO: 1, a CDR2 as set forth in SEQ ID NO: 2, and a CDR3 as set forth in SEQ ID NO: 3; and (ii) an L chain variable region that comprises a CDR1 as set forth in SEQ ID NO: 4, a CDR2 as set forth in SEQ ID NO: 5, and a CDR3 as set forth in SEQ ID NO: 6,
6 to 20 mmol/L Tris buffer,
45 to 150 mmol/L arginine or a salt thereof,
75 to 250 mmol/L sucrose or trehalose, and
0.15 to 0.50 mg/mL poloxamer 188 or polysorbate 20,
wherein the solution formulation has a pH in the range of 6 to 8.