Interleukin-23 receptor antagonist peptides for use in the treatment of psoriasis

HK40137776APending Publication Date: 2026-09-18JANSSEN PHARMA NV
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Patent Information

Application Number
HK62026125484
Authority / Receiving Office
HK · HK
Patent Type
Applications
Current Assignee / Owner
Priority Date
2023-10-11
Filing Date
2026-06-30
Publication Date
2026-09-18
Estimated Expiration
2044-02-29

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Abstract

The present invention relates to methods of administering a cyclic peptide inhibitor of the interleukin-23 receptor (IL-23R) or pharmaceutically acceptable salt or solvate forms thereof, corresponding compositions, assays, methods, and / or uses for treatment of psoriasis.
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Description

Abstract This invention relates to methods of administering cyclic peptide inhibitors of interleukin 23 receptor (IL 23R) or their pharmaceutically acceptable salt or solvate forms, as well as corresponding compositions, assays, methods and / or uses for treating psoriasis.

Claims

CLAIMS WHAT IS CLAIMED IS:

1. A method for treating psoriasis in a subject in need thereof, comprising administering a compound of Formula (I): or a pharmaceutically thereof;wherein after treating with the compound of Formula (I) or a pharmaceutically acceptable salt or solvate thereof, the subject is a responder to treatment by at least one psoriasis measure of response to treatment selected from the group consisting of: (i) a 75% or higher reduction in Psoriasis Area and Severity Index (PASI) compared to a baseline PASI; (ii) an Investigator's Global Assessment (IGA) Score of 2 or lower after treatment; (iii) reduction from baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Score by 1 or higher; and (iv) a reduction of Dermatological Life Quality Index (DLQI) score.

2. A method of treating psoriasis in a subject in need thereof, comprising administering a compound of Formula (I):(I); or a pharmaceutical wherein the subject achieves a 75% or higher reduction in Psoriasis Area and Severity Index (PASI) score compared to a baseline PASI score.

3. The method of claim 1 or 2, wherein the subject achieves a psoriasis measure of response of at least about a 90% reduction in PASI score compared to the baseline PASI score.

4. The method of claim 3, wherein the subject achieves a psoriasis measure of response of about 100% reduction in PASI score compared to the baseline PASI score.

5. The method of claim 1, wherein the subject achieves a psoriasis measure of response of an at least 2-point decrease in IGA score.

6. The method of claim 1 or 5, wherein the subject achieves an Investigator's Global Assessment (IGA) Score of 2 or lower.

7. The method of claim 6 , wherein the subject achieves an IGA score of 1 or lower.

8. The method of claim 7, wherein the subject achieves an IGA score of 0.

9. The method of claim 1 or 5, wherein the patient achieves an Investigator's Global Assessment (IGA) Score of 2 or lower after treatment.

10. The method of claim 9, wherein the patient achieves an IGA score of 1 or lower after treatment.

11. The method of claim 10, wherein the patient achieves an IGA score of 0 after treatment.

12. The method of claim 1 or 2, wherein the psoriasis measure of response is measured atleast 2 weeks after the beginning of treatment.

13. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 4 weeks after the beginning of treatment.

14. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 8 weeks after beginning of treatment.

15. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 16 weeks after beginning of treatment.

16. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 20 weeks after beginning of treatment.

17. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 24 weeks after beginning of treatment.

18. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 28 weeks after beginning of treatment.

19. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 32 weeks after beginning of treatment.

20. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 40 weeks after beginning of treatment.

21. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 52 weeks after beginning of treatment.

22. The method of claim 1 or 2, wherein the psoriasis is plaque psoriasis.

23. The method of claim 22, wherein the psoriasis is moderate to severe plaque psoriasis.

24. The method of claim 1 or 2, wherein the subject is a candidate for phototherapy or systematic therapy.

25. The method of claim 1 or 2, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is a hydrochloride salt of the compound of Formula (I) or solvate thereof.

26. The method of claim 1 or 2, comprising orally administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof.

27. The method of any claim 1 or 2, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof daily.

28. The method of claim 1 or 2, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof in an amount of about 5 mg to about 800 mg.

29. The method of claim 28, comprising administering the compound of Formula (I) orpharmaceutically acceptable salt or solvate thereof in an amount of about 25 mg to about 500 mg.

30. The method of claim 29, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof in an amount of about 50 mg to about 500 mg.

31. The method of claim 30, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof in an amount of about 25 mg.

32. The method of claim 30, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof in an amount of about 50 mg.

33. The method of claim 30, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof in an amount of about 100 mg.

34. The method of claim 30, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof in an amount of about 200 mg.

35. The method of claim 1 or 2, wherein the patient has a Body Surface Area (BSA) of at least 10% prior to treatment.

36. The method of claim 1 or 2, wherein the patient has a PASI score of about 12 to 72 prior to treatment.

37. The method of claim 1 or 2, wherein the subject has an Investigator’s Global Assessment (IGA) of at least 3 prior to treatment.

38. The method of claim 1 or 2, wherein the subject has a Psoriasis Symptom and Sign Diary (PSSD) symptoms score of at least 1 prior to treatment.

39. The method of claim 1 or 2, wherein the subject has a Dermatological Life Quality Index (DLQI) score of greater than 1 prior to treatment.

40. The method of claim 1 or 2, wherein, before the start of treatment with the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof, the subject has not been treated with a biologic agent for psoriasis.

41. The method of claim 1 or 2, wherein, before the start of treatment with the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof, the subject has not been treated with any IL-23 receptor antagonist for psoriasis.

42. A pharmaceutical product for treating a subject diagnosed with psoriasis, comprising a compound of Formula (I):(I); or a pharmaceuticall ministered to said subject, in an amount of at least 25 mg, induces a mean reduction in the Psoriasis Area and Severity Index (PASI) by about 75% or greater, when measured from a baseline PASI score.

43. The pharmaceutical product of claim 42, wherein the subject achieves at least about a 90% reduction in Psoriasis Area and Severity Index score compared to the baseline.

44. The pharmaceutical product of claim 43, wherein the subject achieves about 100% reduction in Psoriasis Area and Severity Index score compared to the baseline.

45. The pharmaceutical product of claim 42, wherein the patient achieves an Investigator's Global Assessment (IGA) Score of 2 or lower after treatment.

46. The pharmaceutical product of any one of claims 42 to 45, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is in an amount of about 25 mg to about 800 mg.

47. The pharmaceutical product of claim 46, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is in an amount of about 50 mg to about 800 mg.

48. The pharmaceutical product of claim 47, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is in an amount of about 50 mg to about 500 mg.

49. The pharmaceutical product of claim 46, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is in an amount of about 25 mg.

50. The pharmaceutical product of claim 48, wherein the compound of Formula (I) orpharmaceutically acceptable salt or solvate thereof is in an amount of about 50 mg.

51. The pharmaceutical product of claim 48, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is in an amount of about 100 mg.

52. The pharmaceutical product of claim 48, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is in an amount of about 200 mg.

53. A method for treating psoriasis in a subject in need thereof, comprising administering a compound of Formula (I): ; or a need thereof in anamount of about 200 mg.

54. The method of claim 53, wherein the method comprises administering the compound of Formula (I) or a pharmaceutically acceptable salt or solvate thereof in an amount of about 200 mg once daily.

55. The method of claim 53, wherein the method further comprises a step of achieving one or more selected from the group consisting of: (i) a 75% or higher reduction in Psoriasis Area and Severity Index (PASI) compared to a baseline PASI; (ii) an Investigator's Global Assessment (IGA) Score of 2 or lower after treatment; (iii) reduction from baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Score by 1 or higher; and (iv) a reduction of Dermatological Life Quality Index (DLQI) score.

56. The method of any one of claims 53 to 55, wherein the psoriasis is plaque psoriasis.

57. The method of claim 56, wherein the psoriasis is moderate to severe plaque psoriasis.

58. The method of any one of claims 53 to 55, wherein the subject is a candidate for phototherapy or systematic therapy.

59. The method of any one of claims 53 to 55, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is a hydrochloride salt of the compound of Formula (I) or solvate thereof.

60. The method of any one of claims 53 to 55, comprising orally administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof.

61. The method of any one of claims 53 to 65, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof daily.

62. The method of any one of claims 53 to 55, wherein the patient has a Body Surface Area (BSA) of at least 10% / prior to treatment.

63. The method of any one of claims 53 to 55, wherein the patient has a PASI score of about 12 to 72 prior to treatment.

64. The method of any one of claims 53 to 55, wherein the subject has an Investigator’s Global Assessment (IGA) of at least 3 prior to treatment.

65. The method of any one of claims 53 to 55, wherein the subject has a Psoriasis Symptom and Sign Diary (PSSD) symptoms score of at least 1 prior to treatment.

66. The method of any one of claims 53 to 55, wherein the subject has a PSSD signs score of at least 1 prior to treatment.

67. The method of any one of claims 53 to 55, wherein the subject has a Dermatological Life Quality Index (DLQI) score of greater than 1 prior to treatment.

68. The method of any one of claims 53 to 55, wherein, before the start of treatment with the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof, the subject has not been treated with a biologic agent for psoriasis.

69. The method of any one of claims 53 to 55, wherein, before the start of treatment with the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof, the subject has not been treated with any IL-23 receptor antagonist for psoriasis.

70. A method of treating a patient population diagnosed with psoriasis, comprising administering a compound of Formula (I):I); or a pharmaceuticall t population in an amount of about 200 mg.

71. The method of claim 70, wherein the method comprises administering the compound of Formula (I) or a pharmaceutically acceptable salt or solvate thereof in an amount of about 200 mg daily.

72. The method of claim 70, wherein the method further comprises a step of achieving one or more selected from the group consisting of: (i) an average of a 75% or higher reduction in Psoriasis Area and Severity Index (PASI) compared to a baseline PASI in the patient population; (ii) an average Investigator's Global Assessment (IGA) Score of 2 or lower after treatment in the patient population; (iii) an average reduction from baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Score by 1 or higher in the patient population; and (iv) a reduction of Dermatological Life Quality Index (DLQI) score in at least 50% of the patient population.

73. The method of any one of claims 70 to 72, wherein the psoriasis is plaque psoriasis.

74. The method of claim 73, wherein the psoriasis is moderate to severe plaque psoriasis.

75. The method of any one of claims 70 to 72, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is a hydrochloride salt of the compound of Formula (I) or solvate thereof.

76. The method of any one of claims 70 to 72, comprising orally administering thecompound of Formula (I) or pharmaceutically acceptable salt or solvate thereof.

77. The method of any one of claims 70 to 72, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof daily.

78. The method of any one of claims 70 to 72, wherein a patient in the patient population has a Body Surface Area (BSA) of at least 10% prior to treatment.

79. The method of any one of claims 70 to 72, wherein a patient in the patient population has a PASI score of about 12 to 72 prior to treatment.

80. The method of any one of claims 70 to 72, wherein a patient in the patient population has an Investigator’s Global Assessment (IGA) of at least 3 prior to treatment.

81. The method of any one of claims 70 to 72, wherein a patient in the patient population has a Psoriasis Symptom and Sign Diary (PSSD) symptoms score of at least 1 prior to treatment.

82. The method of any one of claims 70 to 72, wherein, before the start of treatment with the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof, a patient in the patient population has not been treated with a biologic agent for psoriasis.

83. The method of any one of claims 70 to 72, wherein, before the start of treatment with the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof, a patient in the patient population has not been treated with any IL-23 receptor antagonist for psoriasis.

84. The method of any one of claims 70 to 72, wherein the subject is a patient.

85. The method of claim 84, wherein the subject is an adult or adolescent patient.

86. The method of any one of claims 70 to 85, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is a hydrochloride salt.

87. The method of any one of claims 70 to 86, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is a hydrochloride salt in a crystalline form.

88. A pharmaceutical product for treating a subject with psoriasis, comprising a compound of Formula (I):I); or a pharmaceuticall ompound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is in an amount of about 200 mg.ABSTRACT The present invention relates to methods of administering a cyclic peptide inhibitor of the interleukin-23 receptor (IL-23R) or pharmaceutically acceptable salt or solvate forms thereof, corresponding compositions, assays, methods, and / or uses for treatment of psoriasis.CLAIMSWHAT IS CLAIMED IS:

1. A method for treating psoriasis in a subject in need thereof comprising administering a compound of Formula (I):a pharmaceutically acceptable salt or solvate thereof, to a patient in need thereof; wherein after treating with the compound of Formula (I) or a pharmaceutically acceptable salt or solvate thereof, the subject is a responder to treatment by at least one psoriasis measure of response to treatment selected from the group consisting of:(i) a 75% or higher reduction in Psoriasis Area and Severity Index(PASI) compared to a baseline PASI;(ii) an Investigator's Global Assessment (IGA) Score of 2 or lower after treatment;(iii) reduction from baseline in Psoriasis Symptoms and Signs Diary(PSSD) Symptoms Score by 1 or higher; and(iv) a reduction of Dermatological Life Quality Index (DLQI) score.

2. A method of treating psoriasis in a subject in need thereof, comprising administering a compound of Formula (I):177or a pharmaceutically acceptable salt or solvate thereof, wherein the subject achieves a 75% or higher reduction in Psoriasis Area and Severity Index (PASI) score compared to a baseline PASI score.

3. The method of claim 1 or 2, wherein the subject achieves a psoriasis measure of response of at least about a 90% reduction in PASI score compared to the baseline PASI score.

4. The method of claim 3, wherein the subject achieves a psoriasis measure of response of about 100% reduction in PASI score compared to the baseline PASI score.

5. The method of claim 1. wherein the subject achieves a psoriasis measure of response of an at least 2-point decrease in IGA score.

6. The method of claim 1 or 5, wherein the subject achieves an Investigator's Global Assessment (IGA) Score of 2 or lower.

7. The method of claim 6 , wherein the subject achieves an IGA score of 1 or lower.

8. The method of claim 7, wherein the subject achieves an IGA score of 0.

9. The method of claim 1 or 5, wherein the patient achieves an Investigator's GlobalAssessment (IGA) Score of 2 or lower after treatment.

10. The method of claim 9, wherein the patient achieves an IGA score of 1 or lower after treatment.

11. The method of claim 10, wherein the patient achieves an IGA score of 0 after treatment.

12. The method of claim 1 or 2, wherein the psoriasis measure of response is measured atleast 2 weeks after the beginning of treatment.

13. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 4 weeks after the beginning of treatment.

14. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 8 weeks after beginning of treatment.

15. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 16 weeks after beginning of treatment.

16. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 20 weeks after beginning of treatment.

17. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 24 weeks after beginning of treatment.

18. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 28 weeks after beginning of treatment.

19. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 32 weeks after beginning of treatment.

20. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 40 weeks after beginning of treatment.

21. The method of claim 1 or 2, wherein the psoriasis measure of response is measured at least 52 weeks after beginning of treatment.

22. The method of claim 1 or 2, wherein the psoriasis is plaque psoriasis.

23. The method of claim 22, wherein the psoriasis is moderate to severe plaque psoriasis.

24. The method of claim 1 or 2, wherein the subject is a candidate for phototherapy or systematic therapy.

25. The method of claim 1 or 2, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is a hydrochloride salt of the compound of Formula (I) or solvate thereof.

26. The method of claim 1 or 2, comprising orally administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof.

27. The method of any claim 1 or 2, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof daily.

28. The method of claim 1 or 2, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof in an amount of about 5 mg to about 800 mg.

29. The method of claim 28, comprising administering the compound of Formula (I) or179pharmaceutically acceptable salt or solvate thereof in an amount of about 25 mg to about 500 mg.

30. The method of claim 29, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof in an amount of about 50 mg to about 500 mg.

31. The method of claim 30, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof in an amount of about 25 mg.

32. The method of claim 30, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof in an amount of about 50 mg.

33. The method of claim 30, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof in an amount of about 100 mg.

34. The method of claim 30, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof in an amount of about 200 mg.

35. The method of claim 1 or 2, wherein the patient has a Body Surface Area (BSA) of at least 10% prior to treatment.

36. The method of claim 1 or 2, wherein the patient has a PASI score of about 12 to 72 prior to treatment.

37. The method of claim 1 or 2, wherein the subject has an Investigator’s Global Assessment (IGA) of at least 3 prior to treatment.

38. The method of claim 1 or 2, wherein the subject has a Psoriasis Symptom and Sign Diary (PSSD) symptoms score of at least 1 prior to treatment.

39. The method of claim 1 or 2, wherein the subject has a Dermatological Life Quality Index (DLQI) score of greater than 1 prior to treatment.

40. The method of claim 1 or 2, wherein, before the start of treatment with the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof, the subject has not been treated with a biologic agent for psoriasis.

41. The method of claim 1 or 2, wherein, before the start of treatment with the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof, the subject has not been treated with any IL-23 receptor antagonist for psoriasis.

42. A pharmaceutical product for treating a subject diagnosed with psoriasis, comprising a compound of Formula (I):180or a pharmaceutically acceptable salt or solvate thereof, that when administered to said subject, in an amount of at least 25 mg, induces a mean reduction in the Psoriasis Area and Severity Index (PASI) by about 75% or greater, when measured from a baseline PASI score.

43. The pharmaceutical product of claim 42, wherein the subject achieves at least about a 90% reduction in Psoriasis Area and Severity Index score compared to the baseline.

44. The pharmaceutical product of claim 43, wherein the subject achieves about 100% reduction in Psoriasis Area and Severity Index score compared to the baseline.

45. The pharmaceutical product of claim 42, wherein the patient achieves an Investigator's Global Assessment (IGA) Score of 2 or lower after treatment.

46. The pharmaceutical product of any one of claims 42 to 45, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is in an amount of about 25 mg to about 800 mg.

47. The pharmaceutical product of claim 46, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is in an amount of about 50 mg to about 800 mg.

48. The pharmaceutical product of claim 47, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is in an amount of about 50 mg to about 500 mg.

49. The pharmaceutical product of claim 46, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is in an amount of about 25 mg.

50. The pharmaceutical product of claim 48, wherein the compound of Formula (I) or181pharmaceutically acceptable salt or solvate thereof is in an amount of about 50 mg.

51. The pharmaceutical product of claim 48, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is in an amount of about 100 mg.

52. The pharmaceutical product of claim 48, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is in an amount of about 200 mg.

53. A method for treating psoriasis in a subject in need thereof, comprising administering a compound of Formula (I):or a pharmaceutically acceptable salt or solvate thereof, to a patient in need thereof in an amount of about 200 mg.

54. The method of claim 53, wherein the method comprises administering the compound of Formula (I) or a pharmaceutically acceptable salt or solvate thereof in an amount of about 200 mg once daily.

55. The method of claim 53, wherein the method further comprises a step of achieving one or more selected from the group consisting of:(i) a 75% or higher reduction in Psoriasis Area and Severity Index (PASI) compared to a baseline PASI;(ii) an Investigator's Global Assessment (IGA) Score of 2 or lower after treatment;(iii) reduction from baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Score by 1 or higher; and(iv) a reduction of Dermatological Life Quality Index (DLQI) score.18256. The method of any one of claims 53 to 55, wherein the psoriasis is plaque psoriasis.

57. The method of claim 56, wherein the psoriasis is moderate to severe plaque psoriasis.

58. The method of any one of claims 53 to 55, wherein the subject is a candidate for phototherapy or systematic therapy.

59. The method of any one of claims 53 to 55, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is a hydrochloride salt of the compound of Formula (I) or solvate thereof.

60. The method of any one of claims 53 to 55, comprising orally administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof.

61. The method of any one of claims 53 to 65, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof daily.

62. The method of any one of claims 53 to 55, wherein the patient has a Body Surface Area (BSA) of at least 10% / prior to treatment.

63. The method of any one of claims 53 to 55, wherein the patient has a PASI score of about 12 to 72 prior to treatment.

64. The method of any one of claims 53 to 55. wherein the subject has an Investigator’s Global Assessment (IGA) of at least 3 prior to treatment.

65. The method of any one of claims 53 to 55, wherein the subject has a Psoriasis Symptom and Sign Diary (PSSD) symptoms score of at least 1 prior to treatment.

66. The method of any one of claims 53 to 55, wherein the subject has a PSSD signs score of at least 1 prior to treatment.

67. The method of any one of claims 53 to 55, wherein the subject has a Dermatological Life Quality Index (DLQI) score of greater than 1 prior to treatment.

68. The method of any one of claims 53 to 55, wherein, before the start of treatment with the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof, the subject has not been treated with a biologic agent for psoriasis.

69. The method of any one of claims 53 to 55, wherein, before the start of treatment with the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof, the subject has not been treated with any IL-23 receptor antagonist for psoriasis.

70. A method of treating a patient population diagnosed with psoriasis, comprising administering a compound of Formula (I):or a pharmaceutically acceptable salt or solvate thereof, to said patient population in an amount of about 200 mg.

71. The method of claim 70, wherein the method comprises administering the compound of Formula (I) or a pharmaceutically acceptable salt or solvate thereof in an amount of about 200 mg daily.

72. The method of claim 70, wherein the method further comprises a step of achieving one or more selected from the group consisting of:(i) an average of a 75% or higher reduction in Psoriasis Area and Severity Index (PASI) compared to a baseline PASI in the patient population;(ii) an average Investigator's Global Assessment (IGA) Score of 2 or lower after treatment in the patient population;(iii) an average reduction from baseline in Psoriasis Symptoms and Signs Diary (PSSD) Symptoms Score by 1 or higher in the patient population; and(iv) a reduction of Dermatological Life Qualify Index (DLQI) score in at least 50% of the patient population.

73. The method of any one of claims 70 to 72, wherein the psoriasis is plaque psoriasis.

74. The method of claim 73, wherein the psoriasis is moderate to severe plaque psoriasis.

75. The method of any one of claims 70 to 72. wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is a hydrochloride salt of the compound of Formula (I) or solvate thereof.

76. The method of any one of claims 70 to 72, comprising orally administering thecompound of Formula (I) or pharmaceutically acceptable salt or solvate thereof.

77. The method of any one of claims 70 to 72, comprising administering the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof daily.

78. The method of any one of claims 70 to 72, wherein a patient in the patient population has a Body Surface Area (BSA) of at least 10% prior to treatment.

79. The method of any one of claims 70 to 72, wherein a patient in the patient population has a PASI score of about 12 to 72 prior to treatment.

80. The method of any one of claims 70 to 72, wherein a patient in the patient population has an Investigator’s Global Assessment (IGA) of at least 3 prior to treatment.

81. The method of any one of claims 70 to 72, wherein a patient in the patient population has a Psoriasis Symptom and Sign Diary (PSSD) symptoms score of at least 1 prior to treatment.

82. The method of any one of claims 70 to 72, wherein, before the start of treatment with the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof, a patient in the patient population has not been treated with a biologic agent for psoriasis.

83. The method of any one of claims 70 to 72. wherein, before the start of treatment with the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof, a patient in the patient population has not been treated with any IL-23 receptor antagonist for psoriasis.

84. The method of any one of claims 70 to 72, wherein the subject is a patient.

85. The method of claim 84, wherein the subject is an adult or adolescent patient.

86. The method of any one of claims 70 to 85, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is a hydrochloride salt.

87. The method of any one of claims 70 to 86, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is a hydrochloride salt in a crystalline form.

88. A pharmaceutical product for treating a subject with psoriasis, comprising a compound of Formula (I):185or a pharmaceutically acceptable salt or solvate thereof, wherein the compound of Formula (I) or pharmaceutically acceptable salt or solvate thereof is in an amount of about 200 mg.186