NCT04762277

A Study to Test Whether Spesolimab Helps People With a Skin Disease Called Hidradenitis Suppurativa

Randomized, Double-blind, Placebo-controlled, Study of Spesolimab in Patients With Moderate to Severe Hidradenitis Suppurativa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is open to adults with a chronic inflammatory skin disease called hidradenitis suppurativa. The purpose of this study is to find out whether a medicine called spesolimab helps people with moderate to severe hidradenitis suppurativa. Participants are put into 2 groups by chance. One group takes spesolimab. The other group takes placebo. Every participant has twice the chance of being in the spesolimab group than in the placebo group. Participants get spesolimab or placebo as an infusion into a vein every week for the first 3 weeks. Afterwards, they get spesolimab or placebo as injections under the skin every 2 weeks. Placebo infusions and injections look like spesolimab infusions and injections but do not contain any medicine. Participants are treated in the study for about 3 months. During this time, they visit the study site about 9 times. After completing this part of the study, participants are offered to join another clinical study in which all participants get spesolimab. Participants who cannot join the other study, stay in this study for about 4 more months. During this time, participants do not take spesolimab nor placebo but they visit the study site 2 times to have their health checked. At study visits, doctors thoroughly check the skin of participants to count lumps (nodules) and boils (abscesses). The results between the spesolimab group and the placebo group are compared after 3 months of treatment. The doctors also regularly check the general health of the participants.

Conditions

• Hidradenitis Suppurativa

Interventions

Type	Name	Description
DRUG	Spesolimab - solution for infusion	Solution for infusion
DRUG	Placebo matching spesolimab - solution for infusion	Solution for infusion
DRUG	Spesolimab- solution for injection	Solution for injection
DRUG	Placebo matching to spesolimab- solution for injection	Solution for injection

Timeline

• Start date: 2021-04-06
• Primary completion: 2022-01-19
• Completion: 2022-04-21
• First posted: 2021-02-21
• Last updated: 2025-10-20
• Results posted: 2024-10-09

Locations

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

Regulatory

• FDA-regulated drug study