IP Library Granted Patent US 11,773,173
Granted Patent B2
US 11,773,173 · App. 16/713,271 · Granted Oct 3, 2023

Pharmaceutical composition for prevention and/or treatment of atopic dermatitis comprising IL-31 antagonist as active ingredient

Inventors: Akihisa Kaneko (Shizuoka, JP); Yuki Iwayanagi (Shizuoka, JP); Hidetomo Kitamura (Shizuoka, JP); Yoshinobu Higuchi (Shizuoka, JP); Hiroaki Matsushita (Shizuoka, JP); Ryosuke Mihara (Tokyo, JP); Yumi Yamamoto (Tokyo, JP); Tomohisa Saito (Tokyo, JP); Keiko Hirokawa (Tokyo, JP)
Assignee: Chugai Seiyaku Kabushiki Kaisha
C07K16/2866A61K39/395A61K39/39541A61K45/00A61K45/06C07K16/24C07K16/28A61K2039/505A61K2039/545C07K2317/33C07K2317/52C07K2317/76C07K2317/94
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Quick Facts
Patent No.
US 11,773,173
App. No.
16/713,271
Granted
Oct 3, 2023
Kind
B2
Abstract

In a non-limiting embodiment, there is provided a pharmaceutical composition for prevention and/or treatment of atopic dermatitis comprising an IL-31 antagonist as an active ingredient, wherein the IL-31 antagonist is repeatedly administered in equal amounts at the same dosing interval to a subject with or potentially with atopic dermatitis, at 0.1 to 1000 mg/body/1 day to 12 weeks, preferably at 0.1 to 1000 mg/body/2 weeks, 0.1 to 1000 mg/body/4 weeks, or 0.1 to 1000 mg/body/8 weeks.

Claims (32)

1. A method of treating, or reducing the incidence of, a symptom of atopic dermatitis in a human patient,

the method comprising subcutaneously administering to the patient a series of doses of an anti-human IL-31RA antibody that comprises an H chain variable region as set forth in SEQ ID NO: 7 and an L chain variable region as set forth in SEQ ID NO: 8,

wherein the amount of the anti-human IL-31RA antibody in each dose is 30 mg/body, and

wherein the interval between each dose and the next is 4 weeks.

2. The method of claim 1 , wherein the symptom is pruritus.

3. The method of claim 1 , wherein the anti-human IL-31 RA antibody comprises a human IgG2 Fc region comprising an amino acid sequence with glutamic acid at EU numbering position 419.

4. The method of claim 1 , further comprising administering a topical composition to the patient, wherein the topical composition comprises a topical steroid or a topical calcineurin inhibitor and is administered before, simultaneously with, or after at least one administration of the anti-human IL-31RA antibody.

5. A method of treating, or reducing the incidence of, a symptom of atopic dermatitis in a human patient,

the method comprising administering to the patient an initial dose of an anti-human IL-31RA antibody, followed by subcutaneously administering two or more continuous doses of the anti-human IL-31RA antibody,

wherein the amount of the anti-human IL-31RA antibody in each of the continuous doses is 30 mg/body,

wherein the interval between each two sequential administrations of the continuous doses is 4 weeks, and

wherein the anti-human IL-31 RA antibody comprises an H chain variable region as set forth in SEQ ID NO: 7 and an L chain variable region as set forth in SEQ ID NO: 8.

6. The method of claim 5 , wherein the symptom is pruritus.

7. The method of claim 5 , wherein the anti-human IL-31 RA antibody comprises a human IgG2 Fc region comprising an amino acid sequence with glutamic acid at position 419 (EU numbering).

8. The method of claim 5 , further comprising administering a topical composition to the patient, wherein the topical composition comprises a topical steroid or a topical calcineurin inhibitor and is administered before, simultaneously with, or after at least one administration of the anti-human IL-31RA antibody.

9. The method of claim 8 , wherein the method produces a reduction in symptoms of atopic dermatitis in the patient that is greater than the reduction in symptoms induced by treatment with the anti-human IL-31RA antibody alone.

10. The method of claim 8 , wherein the method permits a lower dosage of the topical composition to be administered than would be needed when the topical composition is administered as a single agent to the patient in the absence of treatment with the anti-human IL-31RA antibody, in order to produce a comparable decrease in symptoms of atopic dermatitis.

11. A method of treating, or reducing the incidence of, a symptom of atopic dermatitis in a human patient,

the method comprising subcutaneously administering to the patient a series of doses of an anti-human IL-31RA antibody that comprises an H chain as set forth in SEQ ID NO: 9 and an L chain as set forth in SEQ ID NO: 10,

wherein the amount of the anti-human IL-31RA antibody in each dose is 30 mg/body, and

wherein the interval between each dose and the next is 4 weeks.

12. The method of claim 11 , wherein the symptom is pruritus.

13. The method of claim 11 , further comprising administering a topical composition to the patient, wherein the topical composition comprises a topical steroid or a topical calcineurin inhibitor and is administered before, simultaneously with, or after at least one administration of the anti-human IL-31RA antibody.

14. A method of treating, or reducing the incidence of, a symptom of atopic dermatitis in a human patient,

the method comprising administering to the patient an initial dose of an anti-human IL-31RA antibody, followed by subcutaneously administering two or more continuous doses of the anti-human IL-31RA antibody,

wherein the amount of the anti-human IL-31RA antibody in each of the continuous doses is 30 mg/body,

wherein the interval between each two sequential administrations of the continuous doses is 4 weeks, and

wherein the anti-human IL-31 RA antibody comprises an H chain as set forth in SEQ ID NO: 9 and an L chain as set forth in SEQ ID NO: 10.

15. The method of claim 14 , wherein the symptom is pruritus.

16. The method of claim 14 , further comprising administering a topical composition to the patient, wherein the topical composition comprises a topical steroid or a topical calcineurin inhibitor and is administered before, simultaneously with, or after at least one administration of the anti-human IL-31RA antibody.

17. The method of claim 16 , wherein the method produces a reduction in symptoms of atopic dermatitis in the patient that is greater than the reduction in symptoms induced by treatment with the anti-human IL-31RA antibody alone.

18. The method of claim 16 , wherein the method permits a lower dosage of the topical composition to be administered than would be needed when the topical composition is administered as a single agent to the patient in the absence of treatment with the anti-human IL-31RA antibody, in order to produce a comparable decrease in symptoms of atopic dermatitis.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 13, 2020
From: KANEKO, AKIHISA; IWAYANAGI, YUKI; KITAMURA, HIDETOMO; HIGUCHI, YOSHINOBU; MATSUSHITA, HIROAKI; MIHARA, RYOSUKE; YAMAMOTO, YUMI; SAITO, TOMOHISA; HIROKAWA, KEIKO
To: CHUGAI SEIYAKU KABUSHIKI KAISHA
Reel/Frame 051929/0054 →
Priority Claims (2)
JP 2015-082699 · Apr 14, 2015 · national
JP 2016-041641 · Mar 4, 2016 · national
Continuity (2)
Continuation 15563743
Related Publication 20200102396A1 · Apr 2, 2020
Cited By (1)
US 12,441,804