A Phase 2, multinational, multicenter, randomized, double blind, placebo controlled, dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn’s disease.

Conditions

Crohn's disease

Brief summary

Proportion of participants achieving endoscopic response

Detailed description

Proportion of participants achieving clinical remission based on Crohn’s Disease Activity Index (CDAI), Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission, Proportion of participants achieving both clinical remission and endoscopic response, Proportion of participants achieving endoscopic remission based on centrally read SES-CD, Proportion of participants achieving CDAI clinical response, Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission, Proportion of participants achieving IBDQ response, Change from baseline in the IBDQ scores, Plasma pre-dose concentrations of SAR441566 at selected visits, Plasma post-dose concentrations of SAR441566 at selected visits, Number of participants experiencing any TEAEs.Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during double-blind (DB) induction and maintenance treatment period, Number of participants experiencing any TEAEs. Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during open-label treatment period

Related papers

No related papers found yet.

Interventions

DRUGMatch placebo to test product

DRUGSAR441566

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants achieving endoscopic response	—

Secondary

Measure	Time frame
Proportion of participants achieving clinical remission based on Crohn’s Disease Activity Index (CDAI), Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission, Proportion of participants achieving both clinical remission and endoscopic response, Proportion of participants achieving endoscopic remission based on centrally read SES-CD, Proportion of participants achieving CDAI clinical response, Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission, Proportion of participants achieving IBDQ response, Change from baseline in the IBDQ scores, Plasma pre-dose concentrations of SAR441566 at selected visits, Plasma post-dose concentrations of SAR441566 at selected visits, Number of participants experiencing any TEAEs.Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during double-blind (DB) induction and maintenance treatment period, Number of participants ex	—

Measure

Time frame

Proportion of participants achieving clinical remission based on Crohn’s Disease Activity Index (CDAI), Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission, Proportion of participants achieving both clinical remission and endoscopic response, Proportion of participants achieving endoscopic remission based on centrally read SES-CD, Proportion of participants achieving CDAI clinical response, Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission, Proportion of participants achieving IBDQ response, Change from baseline in the IBDQ scores, Plasma pre-dose concentrations of SAR441566 at selected visits, Plasma post-dose concentrations of SAR441566 at selected visits, Number of participants experiencing any TEAEs.Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during double-blind (DB) induction and maintenance treatment period, Number of participants ex

—

Countries

Bulgaria, Croatia, Czechia, France, Germany, Hungary, Italy, Netherlands, Poland, Romania, Spain

Outcome results

None listed