NCT04876391

A Study Investigating Long-term Treatment With Spesolimab in People With a Skin Disease Called Hidradenitis Suppurativa Who Completed a Previous Clinical Trial

An Open-label, Long-term Extension Trial of Spesolimab Treatment in Adult Patients With Hidradenitis Suppurativa (HS)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with hidradenitis suppurativa who took part in a previous clinical study of a medicine called spesolimab. Participants who completed treatment can join this study. The purpose of this study is to find out how safe spesolimab is and whether it helps people with hidradenitis suppurativa in the long-term. Participants are in this study for about 2 years and 4 months. For 2 years, participants visit the study site every 2 weeks to get spesolimab injections under the skin. At study visits, doctors check the severity of participants' hidradenitis suppurativa and collect information on any health problems of the participants.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Spesolimab 1200 mg	Participants in the 1368-0052 PoCC trial's placebo arm received a 1200 mg intravenous (i.v.) loading dose at Visit 1, then 600 mg s.c. every two weeks for 12 weeks.
DRUG	Spesolimab 600 mg	Participants in the 1368-0052 PoCC trial's active arm received a 600 mg subcutaneous (s.c.) loading dose of spesolimab at Visit 1, followed by 600 mg s.c. every two weeks for 12 weeks.
DRUG	Placebo matching 600 mg Spesolimab	Participants from the placebo arm of the 1368-0052 PoCC trial will receive a subcutaneous (s.c.) administration of placebo matching 600 mg spesolimab at Visit 1.
DRUG	Placebo matching 1200 mg Spesolimab	Participants from the active arm of the 1368-0052 PoCC trial will receive an intravenous (i.v.) infusion of placebo matching 1200 mg spesolimab at Visit 1

Timeline

• Start date: 2021-08-24
• Primary completion: 2024-04-26
• Completion: 2024-04-26
• First posted: 2021-05-06
• Last updated: 2025-11-14
• Results posted: 2025-06-08

Locations

26 sites across 12 countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Italy, Netherlands, Norway, Poland, Spain

Regulatory

• FDA-regulated drug study