A randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study of brivekimig followed by a maintenance period in participants with moderate to severe hidradenitis suppurativa

Conditions

Hidradenitis suppurativa

Brief summary

Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)

Detailed description

Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90), Change from Baseline in draining tunnel count at Week 16., Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16, Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8, Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16., Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16., Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies., Serum brivekimig concentration throughout the study, Incidence of treatment-emergent (TE) anti-drug antibody responses.

Related papers

No related papers found yet.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 75 (HiSCR75)	—

Secondary

Measure	Time frame
Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90), Change from Baseline in draining tunnel count at Week 16., Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16, Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8, Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16., Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16., Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies., Serum brivekimig concentration throughout the study, Incidence of treatment-emergent (TE) anti-drug antibody respon	—

Measure

Time frame

Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), Percentage of participants achieving Hidradenitis Suppurativa Clinical Response 90 (HiSCR90), Change from Baseline in draining tunnel count at Week 16., Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Week 16, Percentage of participants achieving response on the Hidradenitis Suppurativa Skin Pain Numeric Rating Scale from the HS Symptom Assessment Questionnaire (HS-SAQ skin pain NRS) at week 8, Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) total score at Week 16., Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16., Number of participants with treatment-emergent adverse events (TEAE), serious adverse events (SAE) and laboratory anomalies., Serum brivekimig concentration throughout the study, Incidence of treatment-emergent (TE) anti-drug antibody respon

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Countries

Czechia, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Spain

Outcome results