A Phase 3, Open-Label, Parallel Group, Multicenter, Extension Study Evaluating the Long-Term Treatment of Bimekizumab in Study Participants With Moderate to Severe Hidradenitis Suppurativa

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511035-10-00

Acronym

HS0005

Enrollment

347

Registered

2024-08-08

Start date

2021-06-23

Completion date

2026-01-15

Last updated

2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hidradenitis Suppurativa

Brief summary

Percentage of participants with treatment- emergent adverse events (TEAEs) during the study

Detailed description

Percentage of participants with treatment- emergent serious adverse events (SAEs) during the study, Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study, Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), Percentage of participants with Flare, Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Skin Pain, Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score

Interventions

DRUGbimekizumab

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage of participants with treatment- emergent adverse events (TEAEs) during the study	—

Secondary

Measure	Time frame
Percentage of participants with treatment- emergent serious adverse events (SAEs) during the study, Percentage of participants with treatment-emergent adverse events (TEAEs) leading to withdrawal from the study, Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 50 (HiSCR50), Percentage of participants achieving clinical response as measured by Hidradenitis Suppurativa Clinical Response 75 (HiSCR75), Percentage of participants with Flare, Hidradenitis Suppurativa Symptom Questionnaire (HSSQ) Response for Skin Pain, Absolute change from Baseline in Dermatology Life Quality Index (DLQI) Total Score	—

Measure

Time frame

—

Countries

Bulgaria, France, Germany, Greece, Ireland, Italy, Netherlands, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026