Spesolimab for Pustular Psoriasis

Recruiting in Palo Alto (17 mi)

+64 other locations

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

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 generalized pustular psoriasis (GPP). People can only take part if they have completed treatment in a previous study with spesolimab (1368-0013 or 1368-0027). The goal of this study is to find out how well people with GPP tolerate long-term treatment with spesolimab. The study also tests whether spesolimab helps improve GPP symptoms and how quickly the symptoms improve after a flare-up. Every participant gets spesolimab for almost 5 years (252 weeks). Depending on their symptoms and whether they had a GPP flare during the previous trial, they get spesolimab every few weeks. When participants have a GPP flare during this trial, they get spesolimab as an infusion into a vein. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. To assess the study endpoints, doctors regularly check participants' skin.

Eligibility Criteria

This trial is for men and women who previously participated in a spesolimab study without early dropout. They must consent to continue treatment, use effective birth control if of childbearing potential, and not have moderate/severe psoriasis flare symptoms or certain infections like HIV or tuberculosis.

Inclusion Criteria

Women of childbearing potential 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. A woman is considered of childbearing potential following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

Signed and dated written informed consent and assent for the current trial 1368-0025, in accordance with ICH-GCP and local legislation prior to admission to the current trial

I completed a previous spesolimab trial without stopping early and am willing to continue treatment.

Exclusion Criteria

I haven't taken any medication that could affect this study, except for certain allowed drugs after a specific treatment.

My liver tests are not severely abnormal.

I have no active cancers except for certain skin cancers or cervical cancer that's been treated.

+8 more

Participant Groups

The trial tests the long-term safety and effectiveness of Spesolimab in patients with Generalized Pustular Psoriasis (GPP) who completed prior Spesolimab trials. It aims to understand how well the drug works over an extended period.

3Treatment groups

Experimental Treatment

Group I: Spesolimab (every 6 weeks)Experimental Treatment1 Intervention

Group II: Spesolimab (every 4 weeks)Experimental Treatment1 Intervention

Group III: Spesolimab (every 12 weeks)Experimental Treatment1 Intervention

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

🇺🇸 Approved in United States as Spevigo for: