A randomized, double-blind, placebo-controlled, proof of concept study assessing the efficacy and safety of an anti-TNF-OX40L NANOBODY® molecule, SAR442970, in participants with moderate to severe hidradenitis suppurativa

Conditions

Hidradenitis suppurativa

Brief summary

Percentage of biologic and small molecule immunosuppressive naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)

Detailed description

Time to onset of achieving HiSCR50, Percentage of participants achieving HiSCR75 at Week 16, Percentage of participants achieving HiSCR90 at week 16, Percentage of participants who experience improvement by at least one International Hidradenitis Suppurativa Severity Score System (IHS4) stage at week 16, Change in absolute score from baseline in IHS4 at week 16, Percentage of participants who experience a flare, Percentage of participants achieving IHS4-55, Number of participants with treatment-emergent adverse events (TEAE), adverse events of special interest (AESI) and serious adverse events (SAE) including local reactions, Percentage of participants achieving at least 30% reduction and at least 1 unit reduction from baseline in weekly average of daily Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) at Week 16 among participants with baseline NRS ≥3, Serum SAR442970 concentrations throughout the study, Incidence of anti-SAR442970 antibody positive response throughout the study

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGMatched Placebo for Test

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of biologic and small molecule immunosuppressive naïve participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR50)	—

Secondary

Measure	Time frame
Time to onset of achieving HiSCR50, Percentage of participants achieving HiSCR75 at Week 16, Percentage of participants achieving HiSCR90 at week 16, Percentage of participants who experience improvement by at least one International Hidradenitis Suppurativa Severity Score System (IHS4) stage at week 16, Change in absolute score from baseline in IHS4 at week 16, Percentage of participants who experience a flare, Percentage of participants achieving IHS4-55, Number of participants with treatment-emergent adverse events (TEAE), adverse events of special interest (AESI) and serious adverse events (SAE) including local reactions, Percentage of participants achieving at least 30% reduction and at least 1 unit reduction from baseline in weekly average of daily Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) at Week 16 among participants with baseline NRS ≥3, Serum SAR442970 concentrations throughout the study, Incidence of anti-SAR442970 antibody positive response	—

Measure

Time frame

Time to onset of achieving HiSCR50, Percentage of participants achieving HiSCR75 at Week 16, Percentage of participants achieving HiSCR90 at week 16, Percentage of participants who experience improvement by at least one International Hidradenitis Suppurativa Severity Score System (IHS4) stage at week 16, Change in absolute score from baseline in IHS4 at week 16, Percentage of participants who experience a flare, Percentage of participants achieving IHS4-55, Number of participants with treatment-emergent adverse events (TEAE), adverse events of special interest (AESI) and serious adverse events (SAE) including local reactions, Percentage of participants achieving at least 30% reduction and at least 1 unit reduction from baseline in weekly average of daily Hidradenitis Suppurativa Skin Pain Numeric Rating Scale (HS-Skin Pain NRS) at Week 16 among participants with baseline NRS ≥3, Serum SAR442970 concentrations throughout the study, Incidence of anti-SAR442970 antibody positive response

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Countries

Belgium, Czechia, Denmark, France, Germany, Greece, Italy, Netherlands, Poland, Spain, Sweden

Outcome results

None listed