A multinational, multicenter, double-blind, placebo-controlled phase 2 study to evaluate efficacy and safety of SAR444656 in adult participants with moderate to severe atopic dermatitis.

Conditions

Dermatitis atopic

Brief summary

Percent change from baseline in EASI.

Detailed description

Proportion of participants with validated Investigational Global Assessment (vIGA)-AD of 0 or 1 and a reduction from baseline of ≥2 points, Proportion of participants achieving EASI-75 (reduction of EASI score by ≥75% from baseline)., Absolute change from baseline in EASI., Proportion of participants achieving EASI-50 (reduction of EASI score by ≥50% from baseline)., Proportion of participants achieving EASI-90 (reduction of EASI score by ≥90% from baseline)., Change from baseline in percent body surface area (BSA) affected by AD, Proportion of participants with reduction of weekly average of daily peak pruritus numeric rating scale (PP-NRS) by ≥4 points from baseline, Percent change from baseline in weekly average of daily PP-NRS., Absolute change from baseline in weekly average of daily PP-NRS., Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), investigational medicinal product (IMP) discontinuation due to TEAEs, Plasma SAR444656 concentration.

Related papers

No related papers found yet.

Interventions

DRUGMatched

DRUGSAR444656

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in EASI.	—

Secondary

Measure	Time frame
Proportion of participants with validated Investigational Global Assessment (vIGA)-AD of 0 or 1 and a reduction from baseline of ≥2 points, Proportion of participants achieving EASI-75 (reduction of EASI score by ≥75% from baseline)., Absolute change from baseline in EASI., Proportion of participants achieving EASI-50 (reduction of EASI score by ≥50% from baseline)., Proportion of participants achieving EASI-90 (reduction of EASI score by ≥90% from baseline)., Change from baseline in percent body surface area (BSA) affected by AD, Proportion of participants with reduction of weekly average of daily peak pruritus numeric rating scale (PP-NRS) by ≥4 points from baseline, Percent change from baseline in weekly average of daily PP-NRS., Absolute change from baseline in weekly average of daily PP-NRS., Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), investigational medicinal product (IMP) discontinuation	—

Measure

Time frame

Proportion of participants with validated Investigational Global Assessment (vIGA)-AD of 0 or 1 and a reduction from baseline of ≥2 points, Proportion of participants achieving EASI-75 (reduction of EASI score by ≥75% from baseline)., Absolute change from baseline in EASI., Proportion of participants achieving EASI-50 (reduction of EASI score by ≥50% from baseline)., Proportion of participants achieving EASI-90 (reduction of EASI score by ≥90% from baseline)., Change from baseline in percent body surface area (BSA) affected by AD, Proportion of participants with reduction of weekly average of daily peak pruritus numeric rating scale (PP-NRS) by ≥4 points from baseline, Percent change from baseline in weekly average of daily PP-NRS., Absolute change from baseline in weekly average of daily PP-NRS., Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs), investigational medicinal product (IMP) discontinuation

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Countries

Czechia, Germany, Greece, Poland

Outcome results

None listed