Granted Patent B2

US 12,589,096 · App. 19/274,703 · Granted Mar 31, 2026

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 (26)

1 . 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 from 0.5%-1.5% (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 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,

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

2 . The method of claim 1 , wherein administering the topical formulation continues for 12 weeks.

3 . The method of claim 1 , further comprising stopping the administration of the topical formulation after at least 8 weeks when the patient's skin resolves the atopic dermatitis.

4 . The method of claim 1 , wherein the patient achieves at least a 4 point reduction in itch Numerical Rating Scale score from baseline at week 2 with administration.

5 . The method of claim 1 , wherein the patient achieves at least a 4 point reduction in itch Numerical Rating Scale score from baseline at week 4 of with administration.

6 . The method of claim 1 , wherein the ruxolitinib, or the pharmaceutically acceptable salt thereof, is ruxolitinib phosphate.

7 . The method of claim 1 , wherein the patient has been diagnosed with atopic dermatitis as defined by the Hanifin and Rajka criteria.

8 . The method of claim 7 , wherein the patient has a history of atopic dermatitis for at least 2 years.

9 . The method of claim 8 , wherein the ruxolitinib, or the pharmaceutically acceptable salt thereof, is ruxolitinib phosphate.

10 . The method of claim 1 , wherein the patient achieves an Investigator's Global Assessment score of 0 or 1 with an improvement of at least 2 points from baseline at week 2 of the administration.

11 . The method of claim 1 , wherein the patient achieves an Investigator's Global Assessment score of 0 or 1 with an improvement of at least 2 points from baseline at week 4 of the administration.

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

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

14 . The method of claim 1 , wherein the patient has a BSA of atopic dermatitis involvement of ≥10% at baseline.

15 . The method of claim 14 , wherein the patient has an Eczema Area and Severity Index score of ≥16 at baseline.

16 . The method of claim 14 , wherein the patient has been diagnosed with atopic dermatitis as defined by the Hanifin and Rajka criteria.

17 . The method of claim 16 , wherein the patient has a history of atopic dermatitis for at least 2 years.

18 . The method of claim 17 , wherein the ruxolitinib, or the pharmaceutically acceptable salt thereof, is ruxolitinib phosphate.

19 . The method of claim 1 , wherein the formulation comprises from 0.5%-1% (w/w) on a free base basis of ruxolitinib, or a pharmaceutically acceptable salt thereof.

20 . The method of claim 19 , wherein the ruxolitinib, or the pharmaceutically acceptable salt thereof, is ruxolitinib phosphate.

Assignments (1)

Continuity (9)

References Cited (68)