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

Sintesi

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).

Idoneità

Disegno dello studio

Esiti misurati

1. Esito primario

   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.

   Orizzonte temporale At Week 12

2. Esito secondario

   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).

   Orizzonte temporale From baseline to Week 2

3. Esito secondario

   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.

   Orizzonte temporale At Week 12

4. Esito secondario

   Percentage of Participants with Endoscopic Remission

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

   Orizzonte temporale At Week 12

5. Esito secondario

   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).

   Orizzonte temporale At Week 12

6. Esito secondario

   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).

   Orizzonte temporale At Week 12

7. Esito secondario

   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).

   Orizzonte temporale At Week 12

8. Esito secondario

   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).

   Orizzonte temporale At Week 12

9. Esito secondario

   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).

   Orizzonte temporale At Week 12

10. Esito secondario

    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.

    Orizzonte temporale At Week 12

11. Esito secondario

    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.

    Orizzonte temporale At Week 12

12. Esito secondario

    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).

    Orizzonte temporale Baseline through Week 12

13. Esito secondario

    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).

    Orizzonte temporale Baseline through Week 12

14. Esito secondario

    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.

    Orizzonte temporale Baseline to Week 12

15. Esito secondario

    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.

    Orizzonte temporale Baseline to Week 12

16. Esito secondario

    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".

    Orizzonte temporale Baseline to Week 2 and Week 12

17. Esito secondario

    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".

    Orizzonte temporale Baseline to Week 2 and Week 12

18. Esito secondario

    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.

    Orizzonte temporale Up to 30 Weeks after Baseline

Date

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Centri

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