Granted Patent B2

US 12,396,993 · App. 17/975,939 · Granted Aug 26, 2025

Inventors: Michael Kuligowski (Chadds Ford, PA); Kang Sun (Wallingford, PA); Michael Howell (Kennett Square, PA); May Grace E. Venturanza (Chadds Ford, PA); Jim Lee (Devon, PA)

Assignee: Incyte Corporation

A61K31/519A61K9/0014A61K9/06A61K9/107A61P17/00

Abstract

Claims (40)

1. A method of treating mild to moderate atopic dermatitis in a human patient in need thereof comprising administering to the human patient's skin a topical formulation, comprising 0.75% (w/w) on a free base basis of ruxolitinib, or a pharmaceutically acceptable salt thereof, two times per day,

wherein the patient achieves at least a 4 point reduction in itch Numerical Rating Scale score from baseline at week 8 with administration.

2. The method of claim 1 , wherein the atopic dermatitis is moderate atopic dermatitis.

3. The method of claim 1 , wherein the human patient has a Body Surface Area (BSA) of atopic dermatitis involvement ranging from 3% to 20% at baseline.

4. The method of claim 1 , wherein the patient has an itch Numerical Rating Scale score of >4 at baseline.

5. The method of claim 1 , wherein further comprising continuing the administration of the topical formulation for at least 8 weeks.

6. A method of treating moderate atopic dermatitis in a human patient in need thereof comprising:

administering to the human patient's skin a topical formulation, comprising 0.75% (w/w) on a free base basis of ruxolitinib, or a pharmaceutically acceptable salt thereof, two times per day, and

continuing the administration of the topical formulation for at least about 8 weeks,

wherein the human patient has a Body Surface Area (BSA) of atopic dermatitis involvement ranging from 3% to 20% at baseline,

wherein the patient has an itch Numerical Rating Scale score of ≥4 at baseline, and

wherein the human patient achieves at least a 4 point reduction in itch Numerical Rating Scale score from baseline at week 8 with administration.

7. The method of claim 6 , wherein the human patient achieves IGA treatment success (IGA-TS) as a score of 0 (clear) or 1 (almost clear) with ≥2 grade improvement from baseline at week 8 of the administration.

8. The method of claim 6 , further comprising stopping the administration of the topical formulation after at least 8 weeks when the patient's skin resolves the atopic dermatitis.

9. The method of claim 6 , wherein the patient achieves at least a 4 point reduction in itch Numerical Rating Scale score from baseline at week 4 with administration.

10. The method of claim 6 , wherein the patient achieves at least a 1 point reduction in itch Numerical Rating Scale score from baseline at day 1 of the administration.

11. The method of claim 6 , wherein the patient achieves at least a 1 point reduction in itch Numerical Rating Scale score from baseline at day 2 of said administration.

12. The method of claim 6 , wherein the human patient is aged 12 or older.

13. The method of claim 6 , wherein the patient has been diagnosed with atopic dermatitis as defined by the Hanifin and Rajka criteria.

14. The method of claim 6 , wherein the patient has a history of atopic dermatitis for at least 2 years.

15. The method of claim 6 , wherein the ruxolitinib, or the pharmaceutically acceptable salt thereof, is ruxolitinib phosphate.

16. The method of claim 6 , wherein the patient has a BSA of atopic dermatitis involvement of ≥10% at baseline.

17. The method of claim 16 , wherein the patient has an Eczema Area and Severity Index score of ≥16 at baseline.

18. The method of claim 6 , wherein the ruxolitinib, or the pharmaceutically acceptable salt thereof, is ruxolitinib phosphate, wherein the human patient is aged 12 or older, and the patient has a BSA of atopic dermatitis involvement of ≥10% at baseline.

19. The method of claim 18 , wherein the patient has an Eczema Area and Severity Index score of ≥16 at baseline.

20. The method of claim 7 , wherein the ruxolitinib, or the pharmaceutically acceptable salt thereof, is ruxolitinib phosphate, wherein the human patient is aged 12 or older, and the patient has a BSA of atopic dermatitis involvement of ≥10% at baseline.

21. The method of claim 20 , wherein the patient has an Eczema Area and Severity Index score of ≥16 at baseline.

22. A method of treating moderate atopic dermatitis in a human patient in need thereof comprising:

administering to the human patient's skin a topical formulation, comprising 0.75% (w/w) on a free base basis of ruxolitinib, or a pharmaceutically acceptable salt thereof, two times per day, and

continuing the administration of the topical formulation for at least 8 weeks,

wherein the human patient achieves at least a 4 point reduction in itch Numerical Rating Scale score from baseline at week 8 with administration,

wherein the human patient achieves IGA treatment success (IGA-TS) as a score of 0 (clear) or 1 (almost clear) with >2 grade improvement from baseline at week 8 of the administration, and

wherein the patient:

is aged 12 or older;

has a history of AD for at least 2 years;

has an Investigator's Global Assessment score of 2 to 3 at baseline; and

has a Body Surface Area (BSA) of atopic dermatitis involvement ranging from 3% to 20% at baseline.

23. The method of claim 22 , further comprising stopping the administration of the topical formulation after at least 8 weeks when the patient's skin resolves the atopic dermatitis.

24. The method of claim 22 , wherein the patient achieves at least a 4 point reduction in itch Numerical Rating Scale score from baseline at week 4 with administration.

25. The method of claim 22 , wherein the ruxolitinib, or the pharmaceutically acceptable salt thereof, is ruxolitinib phosphate.

Assignments (1)

Continuity (8)

References Cited (70)