NCT06241573

A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab

Lunsayil LTE: An Extension Trial Assessing Long-term Spesolimab Treatment in Patients With Hidradenitis Suppurativa (HS)

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is open to people with hidradenitis suppurativa (HS) who have completed another study with spesolimab (study 1368-0098 (NCT05819398) or study 1368-0100). The purpose of this study is to find out how well people tolerate spesolimab and whether it helps people with HS in the long-term. For about 1.5 years, participants get spesolimab injections under the skin every 2 weeks. Participants are in the study for about 2 years. During this time, participants have 41 visits. 24 visits are done at the study site. 17 visits can be done by video call at the participant's home. At study visits, doctors check the severity of the participant's HS and collect information on any health problems of the participants.

Conditions

• Hidradenitis Suppurativa (HS)

Interventions

Type	Name	Description
DRUG	Spesolimab	Spesolimab

Timeline

• Start date: 2024-05-08
• Primary completion: 2025-04-11
• Completion: 2025-04-11
• First posted: 2024-02-05
• Last updated: 2026-02-02

Locations

36 sites across 14 countries: United States, Argentina, Australia, Bulgaria, Canada, France, Germany, Japan, Lithuania, Malaysia, Poland, Singapore, South Korea, Spain

Regulatory

• FDA-regulated drug study