Randomised, double-blind, placebo-controlled, Phase IIb/Phase III study to evaluate the efficacy and safety of spesolimab in patients with moderate to severe hidradenitis suppurativa. Lunsayil 1.

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-501074-19-00

Acronym

1368-0098

Enrollment

Registered

2023-05-22

Start date

2023-10-13

Completion date

2025-03-31

Last updated

2025-05-13

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

Conditions

Hidradenitis suppurativa

Brief summary

Percent change from baseline in dT count.

Interventions

DRUGPlacebo for BI 655130 (solution for injection)

DRUGSpesolimab

DRUGPlacebo for BI 655130 (solution for infusion)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline in dT count.	—

Countries

Austria, Belgium, Bulgaria, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Lithuania, Netherlands, Norway, Poland, Portugal, Slovakia, Spain

Outcome results

None listed

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