Spesolimab for Hidradenitis Suppurativa

Recruiting at 140 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Boehringer Ingelheim

Must be taking: Spesolimab

Must not be taking: Immunomodulatory biologics

Disqualifiers: Pregnancy, HIV, Viral hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

Duration: 78 weeks

39 Participants Needed

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

Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly

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

Participants who have completed treatment in the parent hidradenitis suppurativa (HS) spesolimab trial (1368-0098 (NCT05819398) or 1368-0100) without premature discontinuation and are willing and able to continue treatment in this trial

Exclusion Criteria

I am not taking any medications that could affect my trial safety.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive spesolimab injections under the skin every 2 weeks for about 1.5 years

78 weeks

24 visits (in-person), 17 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

• Spesolimab

Trial Overview 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.

Participant Groups

Group I: Patients treated in parent trial 1368-0100 Experimental Treatment 1 Intervention

Group II: Patients treated in Part II of parent trial 1368-0098 (NCT05819398) Experimental Treatment 1 Intervention

Group III: Patients treated in Part I of parent trial 1368-0098 (NCT05819398) Experimental Treatment 1 Intervention

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

Approved in United States as Spevigo for:

• Generalized pustular psoriasis (GPP) in adults and pediatric patients 12 years of age and older and weighing at least 40 kg

Approved in European Union as Spevigo for:

• Generalized pustular psoriasis (GPP) flares in adults

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+