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A Phase III, Multicenter, Double-Blind, Placebo Controlled Study to Assess the Efficacy and Safety of Induction 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
CTIS2024-513054-30-00
Acronym
GA45332
Enrollment
225
Registered
2025-04-14
Start date
2025-04-16
Completion date
Unknown
Last updated
2026-01-20

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 Crohn's disease activity index (CDAI) < 150, 2. Endoscopic response, defined as decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) from baseline≥ 50%

Detailed description

1. Symptomatic remission,, 2. Endoscopic remission,, 3. Ulcer-free endoscopy,, 4. Average of daily number of liquid or very soft stools in the past week (SF), from baseline, 5. Average of daily abdominal pain scores in the past week (APS) from baseline, 6. Bowel urgency, from baseline, 7. Fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), from baseline, 8. Inflammatory Bowel Disease Questionnaire (IBDQ) score, from baseline, 9. Among biomarker-defined subgroups of participants: Clinical remission, 10. Among biomarker-defined subgroups of participants: Endoscopic response, 11. Clinical response, defined as a decrease in CDAI from baseline, 12. Symptomatic response,, 13. Overall change in CD symptoms, as measured by PGIC, from baseline, 14. Overall severity in CD symptoms, as measured by Patient Global Impression of Severity (PGIS), from baseline, 15. General well-being, from baseline, 16. Incidence and severity of the following: Adverse events, 17. Incidence and severity of the following: Serious adverse events, 18. Incidence and severity of the following: Adverse events leading to study treatment discontinuation, 19. Incidence and severity of the following: Adverse events of special interest, 20. 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 Crohn's disease activity index (CDAI) < 150, 2. Endoscopic response, defined as decrease in Simple Endoscopic Score for Crohn's disease (SES-CD) from baseline≥ 50%

Secondary

MeasureTime frame
1. Symptomatic remission,, 2. Endoscopic remission,, 3. Ulcer-free endoscopy,, 4. Average of daily number of liquid or very soft stools in the past week (SF), from baseline, 5. Average of daily abdominal pain scores in the past week (APS) from baseline, 6. Bowel urgency, from baseline, 7. Fatigue, as measured by Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F), from baseline, 8. Inflammatory Bowel Disease Questionnaire (IBDQ) score, from baseline, 9. Among biomarker-defined subgroups of participants: Clinical remission, 10. Among biomarker-defined subgroups of participants: Endoscopic response, 11. Clinical response, defined as a decrease in CDAI from baseline, 12. Symptomatic response,, 13. Overall change in CD symptoms, as measured by PGIC, from baseline, 14. Overall severity in CD symptoms, as measured by Patient Global Impression of Severity (PGIS), from baseline, 15. General well-being, from baseline, 16. Incidence and severity of the following: Adverse eve

Countries

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

Outcome results

None listed

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