A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis

Résumé

This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).

Éligibilité

Conception de l'étude

Critères de jugement

1. Critère de jugement principal

   Percentage of Participants with Clinical Remission

   Percentage of participants achieving Modified Mayo Score (mMS) \<=2 with stool frequency subscore (SFS) = 0 or 1 (up to 1-2 stools more than normal), rectal bleeding subscore (RBS) = 0 (no blood seen) and endoscopic subscore (ES) = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.

   Délai At Week 12

2. Critère de jugement secondaire

   Change in Partial Modified Mayo Score (pmMS)

   Change in pmMS from baseline to Week 2. pmMS is a composite score of ulcerative colitis signs and symptoms activity given by the sum of the SFS and RBS. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed).

   Délai From baseline to Week 2

3. Critère de jugement secondaire

   Percentage of Participants with Endoscopic Improvement

   Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12.

   Délai At Week 12

4. Critère de jugement secondaire

   Percentage of Participants with Endoscopic Remission

   Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 12.

   Délai At Week 12

5. Critère de jugement secondaire

   Percentage of Participants with Clinical Response

   Percentage of participants achieving a decrease in mMS of at least 2 points and 30% from baseline and either a decrease in RBS \>= 1 or RBS = 0 or 1 (no blood seen or stool with streaks of blood) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed). ES is measured on a scale from 0 (normal appearance of mucosa) to 3 (severe disease).

   Délai At Week 12

6. Critère de jugement secondaire

   Percentage of Participants with Histologic Improvement

   Percentage of participants achieving a histologic improvement, defined as Geboes \<=3.1 at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).

   Délai At Week 12

7. Critère de jugement secondaire

   Percentage of Participants with Histologic Remission

   Percentage of participants achieving a histologic remission, defined as Geboes \<2B at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).

   Délai At Week 12

8. Critère de jugement secondaire

   Participants with Histologic-Endoscopic Mucosal Improvement

   Percentage of participants achieving Geboes \<= 3.1 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).

   Délai At Week 12

9. Critère de jugement secondaire

   Percentage of Participants with Histologic-Endoscopic Remission

   Percentage of participants achieving Geboes \< 2 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue).

   Délai At Week 12

10. Critère de jugement secondaire

    Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants

    Percentage of participants achieving mMS \<= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity.

    Délai At Week 12

11. Critère de jugement secondaire

    Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants

    Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups.

    Délai At Week 12

12. Critère de jugement secondaire

    Change in Bowel Urgency

    Change in bowel urgency from baseline through Week 12. Bowel urgency is measured on a scale from 0 (None) to 4 (Severe).

    Délai Baseline through Week 12

13. Critère de jugement secondaire

    Change in Abdominal Pain

    Change in abdominal pain from baseline through Week 12. Abdominal pain is measured on a scale from 0 (None) to 4 (Severe).

    Délai Baseline through Week 12

14. Critère de jugement secondaire

    Change in Fatigue

    Change in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) from baseline to Week 12. FACIT-Fatigue is a 13-item self-reported assessment of the level and impact of fatigue. The overall FACIT-Fatigue score ranges between 0 and 52, with higher scores associated with better quality of life concerns related to fatigue.

    Délai Baseline to Week 12

15. Critère de jugement secondaire

    Change in Health-Related Quality of Life

    Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline to Week 12. IBDQ is a 32-item self-reported assessment of health-related quality of life in participants with inflammatory bowel disease. The overall IBDQ score ranges from 32 to 224, with higher scores associated with better health-related quality of life.

    Délai Baseline to Week 12

16. Critère de jugement secondaire

    Overall Change in UC Symptoms

    Patient Global Impression of Change (PGIC) from baseline to Weeks 2 and 12. PGIC measures overall change in ulcerative colitis symptoms from "Much better" to"Much worse".

    Délai Baseline to Week 2 and Week 12

17. Critère de jugement secondaire

    Overall Severity in UC Symptoms

    Patient Global Impression of Severity (PGIS) from baseline to Weeks 2 and 12. PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe".

    Délai Baseline to Week 2 and Week 12

18. Critère de jugement secondaire

    Incidence and Severity of Adverse Events (AEs)

    Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest.

    Délai Up to 30 Weeks after Baseline

Dates

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Lieux

162 sites sont en recrutement

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