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Monoclonal Antibodies

Spesolimab for Pustular Psoriasis

Phase 4

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 or 1 and a known and documented history of Generalized Pustular Psoriasis (GPP) (per European Rare And Severe Psoriasis Expert Network - ERASPEN - criteria), regardless of Interleukin 36 Receptor Antagonist (IL-36RN) gene mutation status or Patients with a GPP flare and a known and documented history of GPP (per ERASPEN criteria) regardless of IL-36RN gene mutation status.

Must not have

Patients with primary plaque psoriasis vulgaris without presence of pustules or with pustules that are restricted to psoriatic plaques

Patients with primary erythrodermic psoriasis vulgaris

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 1

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is for adults with a severe skin condition called generalized pustular psoriasis (GPP) who experience repeated flare-ups. The study aims to determine if a medication called spesolim

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the exact side effects in this trial aren't listed, similar medications often cause reactions at the infusion site, infections due to immune system suppression, headaches, nausea, and potential allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a mild or no pustulation from Generalized Pustular Psoriasis or I am currently experiencing a GPP flare.

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I have a mild or no pustulation from Generalized Pustular Psoriasis or I am currently experiencing a GPP flare.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have plaque psoriasis without widespread pustules.

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I have widespread red, inflamed skin due to severe psoriasis.

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I have been diagnosed with SAPHO syndrome.

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My liver tests are not severely abnormal.

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I have a condition where my nerves are damaged by my immune system.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Achievement of a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) pustulation sub-score of 0 indicating no visible pustules at Week 1

Secondary study objectives

Achievement of a GPPGA pustulation sub-score of 0 or 1, with a ≥2-point reduction from baseline at Week 1