A parallel-group treatment, Phase 2, double-blind, placebo controlled study to evaluate the efficacy and safety of SAR444656 in adult participants with moderate to severe hidradenitis suppurativa.

Conditions

hidradenitis suppurativa

Brief summary

Percent change from baseline in total abscess and inflammatory nodule (AN) count

Detailed description

Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR 50), Proportion of participants achieving AN count ≤2, Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), Proportion of participants with improvement from baseline in Hurley Stage, Proportion of participants achieving AN50 (at least 50% reduction in the AN count relative to baseline), Change from baseline in participants reported daily worst pain using HS-Skin Pain-Numerical Rating Scale (HS-Skin Pain-NRS), Proportion of participants achieving improvement defined as at least 30% redaction and at least 1 unit reduction in participant daily worst pain using HS-Skin pain-NRS, Change from baseline in the amount of analgesic, 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

DRUGSAR444656

DRUGMatched Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in total abscess and inflammatory nodule (AN) count	—

Secondary

Measure	Time frame
Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR 50), Proportion of participants achieving AN count ≤2, Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), Proportion of participants with improvement from baseline in Hurley Stage, Proportion of participants achieving AN50 (at least 50% reduction in the AN count relative to baseline), Change from baseline in participants reported daily worst pain using HS-Skin Pain-Numerical Rating Scale (HS-Skin Pain-NRS), Proportion of participants achieving improvement defined as at least 30% redaction and at least 1 unit reduction in participant daily worst pain using HS-Skin pain-NRS, Change from baseline in the amount of analgesic, 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 concentr	—

Measure

Time frame

Proportion of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR 50), Proportion of participants achieving AN count ≤2, Absolute change from baseline in International Hidradenitis Suppurativa Severity Score System (IHS4), Proportion of participants with improvement from baseline in Hurley Stage, Proportion of participants achieving AN50 (at least 50% reduction in the AN count relative to baseline), Change from baseline in participants reported daily worst pain using HS-Skin Pain-Numerical Rating Scale (HS-Skin Pain-NRS), Proportion of participants achieving improvement defined as at least 30% redaction and at least 1 unit reduction in participant daily worst pain using HS-Skin pain-NRS, Change from baseline in the amount of analgesic, 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 concentr

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Countries

Germany, Greece, Poland, Spain

Outcome results

None listed