Spesolimab for Hidradenitis Suppurativa

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Boehringer Ingelheim

No Placebo Group

Prior Safety Data

Approved in 2 jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for people with a skin condition called Hidradenitis Suppurativa (HS) who finished a previous spesolimab study without dropping out early. They must be within 16 weeks of their last spesolimab dose and women able to have children need to use effective birth control.

Inclusion Criteria

It has been less than 16 weeks since my last spesolimab treatment.

Exclusion Criteria

I am not pregnant, nursing, nor planning to become pregnant during the trial.

I haven't used any immune-boosting drugs or experimental treatments since my last trial visit.

Treatment Details

The trial tests long-term tolerance and effectiveness of Spesolimab in HS patients. Participants receive Spesolimab injections every two weeks for about 1.5 years, with the total study duration being around 2 years including both in-person and video call visits.

3Treatment groups

Experimental Treatment

Group I: Patients treated in parent trial 1368-0100Experimental Treatment1 Intervention

Group II: Patients treated in Part II of parent trial 1368-0098 (NCT05819398)Experimental Treatment1 Intervention

Group III: Patients treated in Part I of parent trial 1368-0098 (NCT05819398)Experimental Treatment1 Intervention

Spesolimab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Spevigo for: