A Phase 2b multi-national, multi-center, randomized, double-blind, placebo-controlled, dose-ranging study followed by a long-term extension to evaluate the efficacy and safety of SAR442970 in adult participants with moderate to severe ulcerative colitis.

Ulcerative Colitis

Proportion of participants who achieve clinical remission at the end of Week 16 by mMS. Clinical remission is defined as an mMS score of 0 to 2, including SF subscore of 0 or 1, RB subscore of 0, and centrally read mMES of 0 or 1 (score of 1 does not include friability).

Proportion of participants who achieve endoscopic improvement at Week 16. Endoscopic improvement is defined as an mMES of 0 or 1 (where 1 does not include friability)., Proportion of participants who achieve endoscopic response at Week 16. Endoscopic response is defined as an mMES decrease of at least 1., Proportion of participants who achieve endoscopic remission at Week 16. Endoscopic remission is defined as a centrally read mMES of 0., Proportion of participants who achieve endoscopic improvement at Week 52. Endoscopic improvement is defined as an mMES of 0 or 1 (where 1 does not include friability)., Proportion of participants who achieve endoscopic response at Week 52. Endoscopic response is defined as an mMES decrease of at least 1., Proportion of participants who achieve endoscopic remission at Week 52. Endoscopic remission is defined as a centrally read mMES of 0., Proportion of participants who achieve clinical remission at Week 16 by total MS defined as MS ≤2 with no subscore >1., Proportion of participants who achieve clinical response at Week 16 by total MS. Clinical response by total MS is defined as a decrease from baseline in the MS of ≥3 points and at least 30% reduction from baseline, and a decrease in the RB subscore of ≥1 or an absolute RB subscore of 0 or 1., Proportion of participants who achieve clinical response at Week 16 by mMS. Clinical response by mMS is defined as a decrease from baseline in the mMS of ≥2 points and an improvement of ≥30% from baseline plus a decrease in RB subscore ≥1 or an absolute RB subscore ≤1., Proportion of participants who achieve clinical remission at Week 52 by total MS. Clinical remission is defined as a MS ≤2 with no subscore >1., Proportion of participants who achieve clinical response at Week 52 by total MS. Clinical response by total MS is defined as a decrease from baseline in the MS of ≥3 points and at least 30% reduction from baseline, and a decrease in the RB subscore of ≥1 or an absolute RB subscore of 0 or 1., Proportion of participants who achieve clinical remission at Week 52 by mMS. Clinical remission is defined as an mMS score of 0 to 2, including SF subscore of 0 or 1, RB subscore of 0, and centrally read mMES of 0 or 1 (score of 1 does not include friability)., Proportion of participants who achieve clinical response at Week 52 by mMS. Clinical response by mMS is defined as a decrease from baseline in the mMS of ≥2 points and an improvement of ≥30% from baseline plus a decrease in RB subscore ≥1 or an absolute subscore ≤1., Change from baseline in PRO2 total score (SF and RB) at Week 16 and over time., Change from baseline in mMS (SF, RB, and mMES) at Week 16 and over time., Change from baseline in PMS (SF, RB, and PGA) at Week 16 and over time., Proportion of participants who achieve histological improvement at Week 16 by OGS (defined as OGS ≤3.1) to assess inflammation in UC., Proportion of participants who achieve histological remission at Week 16 by RHI (defined as RHI ≤3)., Proportion of participants who achieve histologic remission at Week 16 by OGS (defined as OGS <2B.1)., Proportion of participants who achieve HEMI at Week 16 defined by achievement of modified Mayo endoscopic improvement (mMES of 0 or 1 where 1 does not include friability) and histologic improvement (OGS ≤3.1)., Change from baseline in IBDQ at Week 16 to capture the patient’s experience of IBD on 4 domains of functioning and well-being: bowel and systemic symptoms and emotional and social function., Serum SAR442970 concentrations throughout the study., Incidence of ADAs over time., Number (percentage) of participants with any TEAEs during the Induction and Maintenance treatment periods., Number (percentage) of participants with any TEAEs during the LTE period., Proportion of participants with histological improvement, and HEMI at Week 52., Proportion of participants who receive corticosteroids at Baseline and with a corticosteroid-free remission at Week 52. Steroid free remission is defined as mMS remission criteria and not receiving steroids at the assessment timepoint or ≥90 days before the assessment timepoint., Change from baseline in IBDQ at Week 52., Change from baseline in soluble TNFα over time., Proportion of participants who achieve histological improvement and remission at Week 52 by OGS., Proportion of participants who achieve histological improvement and remission at Week 52 by RHI.

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