Spesolimab for Pustular Psoriasis

Recruiting in Palo Alto (17 mi)

+46 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

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 adults with a serious skin disease called generalized pustular psoriasis (GPP) who have repeated flares of GPP. The purpose of this study is to find out whether a medicine called spesolimab helps people with repeated flares of GPP. Participants are given a single dose of spesolimab as an infusion into a vein on the first day of an outbreak of GPP. They may be given a second dose 1 week later if doctors think it is helpful. They are also treated for additional GPP flares. During the time of the study, doctors regularly examine participants' skin for signs of GPP to see how well the treatment works and take blood samples. The doctors also regularly check participants' health and take note of any unwanted effects.

Eligibility Criteria

Adults with a serious skin condition called generalized pustular psoriasis (GPP) who frequently experience flares can join this study. They must have a history of GPP documented by specific criteria and be willing to use effective birth control if applicable. People under 18 or those not able to consent are excluded.

Inclusion Criteria

I frequently experience severe GPP flares.

Women 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

I am 18 years old or older.

+7 more

Exclusion Criteria

Drug-triggered Acute Generalized Exanthematous Pustulosis (AGEP)

Further exclusion criteria apply.

My liver tests are not severely abnormal.

+6 more

Participant Groups

The trial is testing Spesolimab, given as an infusion into the vein at the start of a GPP flare, possibly followed by a second dose after one week. The study monitors how well Spesolimab treats these flares and checks for any health changes through regular skin exams and blood tests.

1Treatment groups

Experimental Treatment

Group I: GPP PatientsExperimental Treatment1 Intervention

Generalized Pustular Psoriasis (GPP) patients with a recurrent flare following initial GPP flare treatment with intravenous (i.v.) spesolimab.

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

🇺🇸 Approved in United States as Spevigo for: