Spesolimab for Hidradenitis Suppurativa

Recruiting in Palo Alto (17 mi)

+199 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Boehringer Ingelheim

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests spesolimab, a drug that may help adults with moderate to severe hidradenitis suppurativa (HS). It works by calming the immune system to reduce inflammation and heal the skin. The study aims to see if spesolimab is effective and safe for these patients.

Eligibility Criteria

Adults with moderate to severe hidradenitis suppurativa (HS) can join this trial. They must have had an inadequate response to antibiotics, be biologic naive or only exposed to TNF inhibitors for HS treatment, and not have used other immunosuppressive biologics. Pregnant women and those with certain allergies or a history of cancer within the last 5 years are excluded.

Inclusion Criteria

I have moderate to severe hidradenitis suppurativa.

I have not used biologic treatments or have used TNF inhibitors for my condition.

I have signed and understand the consent form for this trial.

+14 more

Exclusion Criteria

I haven't used any experimental drugs or devices in the last 30 days or 5 half-lives of the drug.

I am not pregnant, nursing, or planning to become pregnant during the trial.

I haven't had cancer in the last 5 years, except for certain skin cancers or cervical cancer that was treated.

+6 more

Participant Groups

The study tests if spesolimab helps people with HS. Participants are randomly assigned into groups receiving different doses of spesolimab or placebo via injections. After initial weekly treatments, they switch to every two weeks, and after four months, placebo groups start on spesolimab.

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Part II: Active (treatment) groupExperimental Treatment1 Intervention

Group II: Part I: Medium dose groupExperimental Treatment2 Interventions

Group III: Part I: Low dose groupExperimental Treatment2 Interventions

Group IV: Part I: High dose groupExperimental Treatment2 Interventions

Group V: Part II: Placebo groupPlacebo Group1 Intervention

Group VI: Part I: Placebo groupPlacebo Group2 Interventions