A randomized, double-blind, multicenter phase III study to evaluate the long-term efficacy and safety of ABX464 25 mg or 50 mg once daily as a maintenance therapy in subjects with moderately to severely active ulcerative colitis

Conditions

Moderately to severely active ulcerative colitis

Brief summary

Proportion of subjects in clinical remission at Week 44.

Detailed description

Proportion of subjects with endoscopic improvement at Week 44, Proportion of subjects with symptomatic remission at Week 44, Proportion of subjects with corticosteroid-free clinical remission at Week 44., Proportion of subjects with sustained clinical remission at Week 44., Proportion of subjects with HEMI per Geboes scoring at Week 44, Proportion of subjects with endoscopic remission at Week 44., Incidence of all treatment-emergent adverse events (TEAEs), causally related adverse events (AEs), all serious adverse events (SAEs) and causally related SAEs classified, by severity, Incidence of AEs leading to investigational medicinal product 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

Related papers

No related papers found yet.

Interventions

DRUGThe placebo for the 25 and 50 mg ABX464 hard capsules.

DRUGABX464

DRUGPLACEBO

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of subjects in clinical remission at Week 44.	—

Secondary

Measure	Time frame
Proportion of subjects with endoscopic improvement at Week 44, Proportion of subjects with symptomatic remission at Week 44, Proportion of subjects with corticosteroid-free clinical remission at Week 44., Proportion of subjects with sustained clinical remission at Week 44., Proportion of subjects with HEMI per Geboes scoring at Week 44, Proportion of subjects with endoscopic remission at Week 44., Incidence of all treatment-emergent adverse events (TEAEs), causally related adverse events (AEs), all serious adverse events (SAEs) and causally related SAEs classified, by severity, Incidence of AEs leading to investigational medicinal product 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	—

Measure

Time frame

Proportion of subjects with endoscopic improvement at Week 44, Proportion of subjects with symptomatic remission at Week 44, Proportion of subjects with corticosteroid-free clinical remission at Week 44., Proportion of subjects with sustained clinical remission at Week 44., Proportion of subjects with HEMI per Geboes scoring at Week 44, Proportion of subjects with endoscopic remission at Week 44., Incidence of all treatment-emergent adverse events (TEAEs), causally related adverse events (AEs), all serious adverse events (SAEs) and causally related SAEs classified, by severity, Incidence of AEs leading to investigational medicinal product 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

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Countries

Belgium, France, Germany, Italy, Poland, Spain

Outcome results

None listed