Moderately to severely active ulcerative colitis
Conditions
Brief summary
Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8.
Detailed description
Proportion of subjects who achieve endoscopic improvement at week 8., Proportion of subjects who achieve clinical response per MMS at week 8., Proportion of subjects with symptomatic remission at week 8., Proportion of subjects with HEMI per Geboes scoring at week 8., Incidence of all treatment-emergent adverse events (TEAEs), causally related TEAEs, all serious adverse events (SAE) and causally related SAEs classified by severity., Incidence of adverse events leading to investigational discontinuation and study discontinuation., Incidence of adverse events of special interest (AESIs)., Incidence of clinically significant laboratory abnormalities., Incidence of clinically significant abnormalities regarding vital signs and ECG
Interventions
DRUGABX464
Sponsors
Abivax
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects who achieve clinical remission per Modified Mayo Score at week 8. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects who achieve endoscopic improvement at week 8., Proportion of subjects who achieve clinical response per MMS at week 8., Proportion of subjects with symptomatic remission at week 8., Proportion of subjects with HEMI per Geboes scoring at week 8., Incidence of all treatment-emergent adverse events (TEAEs), causally related TEAEs, all serious adverse events (SAE) and causally related SAEs classified by severity., Incidence of adverse events leading to investigational discontinuation and study discontinuation., Incidence of adverse events of special interest (AESIs)., Incidence of clinically significant laboratory abnormalities., Incidence of clinically significant abnormalities regarding vital signs and ECG | — |
Countries
Belgium, France, Germany, Italy, Poland, Spain
Outcome results
None listed