A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease

Zusammenfassung

The purpose of this study is to evaluate how-well icotrokinra works (clinical efficacy) and how safe it is (safety) in participants with moderately to severely active Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract).

Eignung

Studiendesign

Endpunkte

1. Primärer Endpunkt

   Induction Study 1: Number of Participants with Clinical Response at Week 12

   Clinical response is defined as a greater than or equal to (\>=) 100-point reduction from baseline in Crohn's Disease Activity Index (CDAI) score. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

   Zeitrahmen At Week 12

2. Primärer Endpunkt

   Induction Study 2: Number of Participants with Clinical Remission at Week 12 (Co-Primary Endpoint)

   Clinical remission is defined as CDAI score less than (\<) 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

   Zeitrahmen At Week 12

3. Primärer Endpunkt

   Induction Study 2: Number of Participants with Endoscopic Response at Week 12 (Co-Primary Endpoint)

   Endoscopic response is defined as greater than (\>) 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

   Zeitrahmen At Week 12

4. Primärer Endpunkt

   Maintenance Study: Number of Participants with Clinical Remission at Week 40 (Co-Primary Endpoint)

   Clinical remission is defined as CDAI score \< 150. CDAI scores range from 0 to approximately 600. Higher score indicates higher disease activity.

   Zeitrahmen At Week 40

5. Primärer Endpunkt

   Maintenance Study: Number of Participants with Endoscopic Response at Week 40 (Co-Primary Endpoint)

   Endoscopic response is defined as \> 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

   Zeitrahmen At Week 40

6. Sekundärer Endpunkt

   Induction Study 1: Number of Participants with Clinical Remission at Week 12

   Clinical remission is defined as CDAI score \< 150. CDAI scores ranging from 0 to approximately 600. Higher score indicates higher disease activity.

   Zeitrahmen At Week 12

7. Sekundärer Endpunkt

   Induction Study 1: Number of Participants with Endoscopic Response at Week 12

   Endoscopic response is defined as \> 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. SES-CD score can range from 0 to 56. Higher scores indicating more severe disease.

   Zeitrahmen At Week 12

8. Sekundärer Endpunkt

   Induction Study 1: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

   An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.

   Zeitrahmen Up to 4 weeks after last dose of study drug (i.e., up to Week 16)

9. Sekundärer Endpunkt

   Induction Study 2: Number of Participants with Patient Reported Outcomes (PRO)-2 Remission at Week 12

   PRO-2 remission is defined as an abdominal pain (AP) mean daily score less than or equal to (\<=) 1 and stool frequency (SF) mean daily score \<= 2.8, and no worsening of AP or SF from baseline.

   Zeitrahmen At Week 12

10. Sekundärer Endpunkt

    Induction Study 2: Number of Participants with Clinical Response at Week 12

    Clinical response is defined as a \>= 100-point reduction from baseline in CDAI score.

    Zeitrahmen At Week 12

11. Sekundärer Endpunkt

    Induction Study 2: Number of Participants Reporting Both Clinical Remission and Endoscopic Response at Week 12

    Clinical remission is defined as CDAI score \< 150. Endoscopic response is defined as \> 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. This is a composite endpoint defined to measure achievement of both clinical remission and endoscopic response at the participant level.

    Zeitrahmen At Week 12

12. Sekundärer Endpunkt

    Induction Study 2: Number of Participants with Clinical Response at Week 4

    Clinical response is defined as a \>= 100-point reduction from baseline in CDAI score.

    Zeitrahmen At Week 4

13. Sekundärer Endpunkt

    Induction Study 2: Number of Participants with Endoscopic Remission at Week 12

    Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component.

    Zeitrahmen At Week 12

14. Sekundärer Endpunkt

    Induction Study 2: Number of Participants with Deep Remission at Week 12

    Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as CDAI score \< 150-point. Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component.

    Zeitrahmen At Week 12

15. Sekundärer Endpunkt

    Induction Study 2: Number of Participants with Inflammatory Bowel Disease Questionnaire (IBDQ) Remission at Week 12

    IBDQ remission is defined as IBDQ score \>= 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with inflammatory bowel disease (IBD) that will be used to evaluate the disease-specific health-related quality of life (HRQoL) across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

    Zeitrahmen At Week 12

16. Sekundärer Endpunkt

    Induction Study 2: Number of Participants with Fatigue Response at Week 12

    Fatigue response is defined as a \>= 7 point reduction in the patient reported outcomes measurement information system (PROMIS)-Fatigue Short Form 7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise). Item responses are rated on a five-point scale ranging from "never" to "always". Higher scores indicate more fatigue.

    Zeitrahmen At Week 12

17. Sekundärer Endpunkt

    Induction Study 2: Number of Participants with Clinical Remission at Week 4

    Clinical remission is defined as CDAI score\< 150.

    Zeitrahmen At Week 4

18. Sekundärer Endpunkt

    Induction Study 2: Number of Participants Reporting Both Histologic Remission and Endoscopic Remission at Week 12

    Histologic remission is defined as a Robarts Histopathology Index score \<=3, where each of the items of lamina propria neutrophils, neutrophils in epithelium, and erosions or ulcerations must be equal to 0. Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component. This is a composite endpoint defined as achieving both histologic remission and endoscopic remission at the participant level.

    Zeitrahmen At Week 12

19. Sekundärer Endpunkt

    Induction Study 2: Number of Participants with AEs and SAEs

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.

    Zeitrahmen Up to 4 weeks after last dose of study drug (i.e., up to Week 16)

20. Sekundärer Endpunkt

    Maintenance Study: Number of Participants with PRO-2 remission at Week 40

    PRO-2 remission is defined as an abdominal pain (AP) mean daily score \<= 1 and stool frequency (SF) mean daily score \<= 2.8, and no worsening of AP or SF from baseline.

    Zeitrahmen At Week 40

21. Sekundärer Endpunkt

    Maintenance Study: Number of Participants with Endoscopic Remission at Week 40

    Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component.

    Zeitrahmen At Week 40

22. Sekundärer Endpunkt

    Maintenance Study: Number of Participants with 90-Day Corticosteroid-Free Clinical Remission at Week 40

    90-day corticosteroid-free clinical remission is defined as the clinical remission at the visit and not receiving corticosteroids for at least 90 days prior to the visit. Clinical remission is defined as CDAI score \< 150.

    Zeitrahmen At Week 40

23. Sekundärer Endpunkt

    Maintenance Study: Number of Participants with Maintenance of Clinical Remission at Week 40

    Participants with clinical remission at Week 40 among those with clinical remission at Week 0 of the maintenance study will be analyzed. Clinical remission is defined as CDAI score \< 150.

    Zeitrahmen At Week 40

24. Sekundärer Endpunkt

    Maintenance Study: Number of Participants Reporting Both Clinical Remission and Endoscopic Response at Week 40

    Clinical remission is defined as CDAI score \< 150. Endoscopic response is defined as \> 50% improvement from baseline in SES-CD score or a decrease of at least 2 points in participants with a baseline score of 4 and isolated ileal disease. This is a composite endpoint defined to measure achievement of both clinical remission and endoscopic response at the participant level.

    Zeitrahmen At Week 40

25. Sekundärer Endpunkt

    Maintenance Study: Number of Participants with Deep Remission at Week 40

    Deep remission is a composite endpoint defined as achieving both clinical remission and endoscopic remission at the participant level. Clinical remission is defined as CDAI score \< 150. Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component.

    Zeitrahmen At Week 40

26. Sekundärer Endpunkt

    Maintenance Study: Number of Participants Reporting Both Histologic Remission and Endoscopic Remission at Week 40

    Histologic remission is defined as a Robarts Histopathology Index score \<=3, where each of the items of lamina propria neutrophils, neutrophils in epithelium, and erosions or ulcerations must be equal to 0. Endoscopic remission is defined as SES-CD \<= 4 with at least a 2-point reduction from baseline and no sub score \>1 in any individual component. This is a composite endpoint defined as achieving both histologic remission and endoscopic remission at the participant level.

    Zeitrahmen At Week 40

27. Sekundärer Endpunkt

    Maintenance Study: Number of Participants with IBDQ Remission at Week 40

    IBDQ remission is defined as IBDQ score \>= 170. IBDQ is a validated, 32-item, self-reported questionnaire for participants with IBD that will be used to evaluate the disease-specific HRQoL across 4 dimensional scores: bowel symptoms (loose stools, abdominal pain), systemic symptoms (fatigue, altered sleep pattern), social function (work attendance, need to cancel social events), and emotional function (anger, depression, irritability). Scores range from 32 to 224, with higher scores indicating better outcomes.

    Zeitrahmen At Week 40

28. Sekundärer Endpunkt

    Maintenance Study: Number of Participants with Fatigue Response at Week 40

    Fatigue response is defined as a \>= 7 point reduction in the PROMIS-Fatigue Short Form 7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise). Item responses are rated on a five-point scale ranging from "never" to "always". Higher scores indicate more fatigue.

    Zeitrahmen At Week 40

29. Sekundärer Endpunkt

    Maintenance Study : Number of Participants with AEs and SAEs

    An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product that does not necessarily have a causal relationship with the intervention. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, is a suspected transmission of any infectious agent via a medicinal product and is medically important.

    Zeitrahmen Up to 4 weeks after last dose of study drug (i.e., up to Week 44)

Daten

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