Claims for Patent: 12,419,889

Summary for Patent: 12,419,889

Title:	Methods of treating chronic spontaneous urticaria using a bruton's tyrosine kinase inhibitor
Abstract:	The present disclosure relates to methods for treating Chronic Spontaneous Urticaria using a compound of Formula (I) or a pharmaceutically acceptable salt thereof. Also disclosed herein is a compound of Formula (I) or a pharmaceutically acceptable salt thereof, for treating Chronic Spontaneous Urticaria patients, as well as medicaments, dosing regimens, pharmaceutical formulations, dosage forms, and kits for use in the disclosed uses and methods.
Inventor(s):	Souvik BHATTACHARYA, Bruno BIETH, Maciej CABANSKI, Bruno CENNI, Stefan De Buck, Martin Kaul, Arvind KINHIKAR, Andrijana RADIVOJEVIC, Thomas Severin, Julian STORIM, Alessandra VITALITI GARAMI
Assignee:	Novartis AG
Application Number:	US17/612,778
Patent Claims:	1. A method of treating chronic spontaneous urticaria in a subject in need of such treatment, comprising administering to the subject a daily dose of from about 10 mg to about 100 mg of a compound of Formula (I): or a pharmaceutically acceptable salt thereof. 2. The method of claim 1, wherein the daily dose of the compound of Formula (I) is about 100 mg. 3. The method of claim 1, wherein the daily dose of the compound of Formula (I) is about 50 mg. 4. The method of claim 3, wherein the compound of Formula (I) is administered at a dose of 25 mg twice a day to an adult. 5. The method of claim 4, wherein prior to the treatment with the compound of Formula (I), the subject has been previously treated with H1-antihistamine and remains symptomatic despite treatment with the H1-antihistamine, as defined by a presence of itch and hives for ≥6 consecutive weeks. 6. The method of claim 4, wherein prior to the treatment with the compound of Formula (I), the subject has moderate to severe chronic spontaneous urticaria as defined by a Weekly Urticaria Activity Score (UAS7) of ≥16. 7. The method of claim 4, wherein the subject achieves by week 12 of the treatment at least one of the following: a) a reduction of hives and itch as measured by a Urticaria Activity Score (UAS) of ≤6; or a complete absence of hives and itch as measured by a Weekly Urticaria Activity Score (UAS7) of zero; b) a Dermatology Life Quality Index (DLQI)=0-1; and c) an absence of angioedema as measured by a Weekly Angioedema Activity Score (AAS7) of zero. 8. The method of claim 3, wherein the compound of Formula (I) is administered at a dose of 50 mg once a day to an adult. 9. The method of claim 8, wherein prior to the treatment with the compound of Formula (I), the subject has been previously treated with H1-antihistamine and remains symptomatic despite treatment with the H1-antihistamine, as defined by a presence of itch and hives for ≥6 consecutive weeks. 10. The method of claim 8, wherein prior to the treatment with the compound of Formula (I), the subject has moderate to severe chronic spontaneous urticaria as defined by a Weekly Urticaria Activity Score (UAS7) score of ≥16. 11. The method of claim 8, wherein the subject achieves by week 12 of the treatment at least one of the following: a) a reduction of hives and itch as measured by a Urticaria Activity Score (UAS) of ≤6; or a complete absence of hives and itch as measured by a Weekly Urticaria Activity Score (UAS7) of zero; b) a Dermatology Life Quality Index (DLQI)=0-1; and c) an absence of angioedema as measured by a Weekly Angioedema Activity Score (AAS7) of zero. 12. The method of claim 1, wherein the daily dose of the compound of Formula (I) is about 35 mg. 13. The method of claim 1, wherein the daily dose of the compound of Formula (I) is about 25 mg. 14. The method of claim 1, wherein the daily dose of the compound of Formula (I) is about 20 mg. 15. The method of claim 14, wherein the compound of Formula (I) is administered at a dose of 10 mg twice a day. 16. The method of claim 15, wherein prior to the treatment with the compound of Formula (I), the subject has been previously treated with H1-antihistamine and remains symptomatic despite treatment with the H1-antihistamine, as defined by a presence of itch or hive for ≥6 consecutive weeks. 17. The method of claim 15, wherein prior to the treatment with the compound of Formula (I), the subject has moderate to severe chronic spontaneous urticaria as defined by a Weekly Urticaria Activity Score (UAS7) score of ≥16. 18. The method of claim 15, wherein the subject achieves by week 12 of the treatment at least one of the following: a) a reduction of hives and itch as measured by a Urticaria Activity Score (UAS) of ≤6; or a complete absence of hives and itch as measured by a Weekly Urticaria Activity Score (UAS7) of zero; b) a Dermatology Life Quality Index (DLQI)=0-1; and c) an absence of angioedema as measured by a Weekly Angioedema Activity Score (AAS7) of zero. 19. The method of claim 1, wherein the compound of Formula (I) is administered once a day at a dose of about 10 mg, about 35 mg, about 50 mg, or about 100 mg. 20. The method of claim 1, wherein the compound of Formula (I) is administered at a dose of about 10 mg, about 25 mg, or about 50 mg twice daily. 21. The method of claim 1, wherein prior to the treatment with the compound of Formula (I), or the pharmaceutically acceptable salt thereof, the subject has been previously treated with a systemic agent for chronic spontaneous urticaria. 22. The method of claim 21, wherein the systemic agent is selected from the group consisting of an H1-antihistamine, an H2-antihistamine, a leukotriene receptor antagonist, and a combination thereof. 23. The method of claim 1, wherein prior to the treatment with the compound of Formula (I), or the pharmaceutically acceptable salt thereof, the subject has not been previously treated with a systemic agent for chronic spontaneous urticaria. 24. The method of claim 1, wherein the subject has moderate to severe chronic spontaneous urticaria. 25. The method of claim 1, wherein the subject is selected according to at least one of the following criteria: a) prior to the treatment with the compound of Formula (I) or a pharmaceutically acceptable salt thereof, the subject has a Weekly Urticaria Activity Score (UAS7) of ≥16; b) prior to the treatment with the compound of Formula (I) or a pharmaceutically acceptable salt thereof, the subject has a Weekly Hives Severity Score (HSS7) ≥8. 26. The method of claim 1, wherein the subject is an adult. 27. The method of claim 1, wherein the subject achieves by week 4 or at week 12 of the treatment at least one of the following: a) a reduction of hives and itch as measured by a Urticaria Activity Score (UAS)≤6; or a complete absence of hives and itch as measured by a Weekly Urticaria Activity Score (UAS7) of zero; b) a Dermatology Life Quality Index (DLQI)=0-1; and c) an absence of angioedema as measured by a Weekly Angioedema Activity Score (AAS7) of zero. 28. The method of claim 1, wherein the subject achieves a sustained response as measured by at least one of the following at week 4 after completion of the treatment: a) a complete hives and itch response as measured by a Weekly Urticaria Activity Score (UAS7) of zero; b) a Dermatology Life Quality Index (DLQI)=0-1; and c) a continued absence of angioedema as measured by a Weekly Angioedema Activity Score (AAS7) of zero. 29. The method of claim 1, wherein the compound of Formula (I), or the pharmaceutically acceptable salt thereof, is disposed in a pharmaceutical formulation, wherein the pharmaceutical formulation further comprises a pharmaceutically acceptable carrier. 30. The method of claim 1, wherein the compound of Formula (I), or the pharmaceutically acceptable salt thereof, has a Tmax of about 0.5-3 hours.