A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of Izokibep in Subjects with Moderate to Severe Hidradenitis Suppurativa

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-503160-33-00

Acronym

22107

Enrollment

Registered

2023-11-13

Start date

2023-12-15

Completion date

2025-01-27

Last updated

2024-12-04

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

Conditions

Hidradenitis Suppurativa

Brief summary

HiSCR75 at Week 12

Detailed description

HiSCR90 at Week 12 • HiSCR100 at Week 12 • HiSCR50 at Week 12• HS flares through Week 12 • Change in DLQI from baseline to Week 12 • AN count of 0, 1, or 2 at Week 12 • Change from baseline in NRS in Patient Global Assessment of Skin Pain at its worst at Week 12 • TEAEs and SAEs • Laboratory values and vital signs at collected timepoints

Interventions

DRUGPlacebo

DRUGIzokibep

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
HiSCR75 at Week 12	—

Secondary

Measure	Time frame
HiSCR90 at Week 12 • HiSCR100 at Week 12 • HiSCR50 at Week 12• HS flares through Week 12 • Change in DLQI from baseline to Week 12 • AN count of 0, 1, or 2 at Week 12 • Change from baseline in NRS in Patient Global Assessment of Skin Pain at its worst at Week 12 • TEAEs and SAEs • Laboratory values and vital signs at collected timepoints	—

Countries

France, Germany, Hungary, Poland, Spain

Outcome results

None listed

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