Skip to content

A Phase III, Multicenter, Double-Blind, Placebo Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy with RO7790121 in Patients with Moderately to Severely Active Crohn's Disease

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-513053-69-00
Acronym
GA45331
Enrollment
348
Registered
2025-04-14
Start date
2025-04-16
Completion date
Unknown
Last updated
2026-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderately to Severely Active Crohn's Disease (CD)

Brief summary

1. Clinical remission, defined as CDAI < 150,, 2. Endoscopic response, defined as decrease in SES-CD from baseline ≥ 50%,

Detailed description

1. Clinical remission, as defined above,, 2. Endoscopic response, as defined above,, 3. Symptomatic remission,, 4. Endoscopic remission,, 5. Ulcer-free endoscopy,, 6. SF, from baseline, 7. APS, from baseline, 8. Endoscopic remission,, 9. Symptomatic remission,, 10. Corticosteroid-free clinical remission,, 11. Maintenance of clinical remission,, 12. Maintenance of endoscopic response,, 13. Clinical remission and endoscopic remission,, 14. Ulcer-free endoscopy,, 15. Bowel urgency, from baseline, 16. Fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), from baseline, 17. Inflammatory Bowel Disease Questionnaire (IBDQ) score, from baseline, 18. Clinical remission, 19. Clinical remission, 20. Endoscopic response, 21. Endoscopic response, 22. Clinical response,, 23. Symptomatic response,, 24. Overall change in CD symptoms,, 25. Overall severity in CD symptoms,, 26. General well-being, from baseline, 27. Incidence and severity of the following: - Adverse events, 28. Incidence and severity of the following: - Serious adverse events, 29. Incidence and severity of the following: - Adverse events leading to study treatment discontinuation, 30. Incidence and severity of the following: - Adverse events of special interest, 31. Presence of draining fistulas

Interventions

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Clinical remission, defined as CDAI < 150,, 2. Endoscopic response, defined as decrease in SES-CD from baseline ≥ 50%,

Secondary

MeasureTime frame
1. Clinical remission, as defined above,, 2. Endoscopic response, as defined above,, 3. Symptomatic remission,, 4. Endoscopic remission,, 5. Ulcer-free endoscopy,, 6. SF, from baseline, 7. APS, from baseline, 8. Endoscopic remission,, 9. Symptomatic remission,, 10. Corticosteroid-free clinical remission,, 11. Maintenance of clinical remission,, 12. Maintenance of endoscopic response,, 13. Clinical remission and endoscopic remission,, 14. Ulcer-free endoscopy,, 15. Bowel urgency, from baseline, 16. Fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), from baseline, 17. Inflammatory Bowel Disease Questionnaire (IBDQ) score, from baseline, 18. Clinical remission, 19. Clinical remission, 20. Endoscopic response, 21. Endoscopic response, 22. Clinical response,, 23. Symptomatic response,, 24. Overall change in CD symptoms,, 25. Overall severity in CD symptoms,, 26. General well-being, from baseline, 27. Incidence and severity of the following: - A

Countries

Austria, Belgium, Bulgaria, Croatia, Czechia, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026