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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.
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

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.
Select...
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 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

Side effects data

From 2020 Phase 2 & 3 trial • 98 Patients • NCT03482635
8%
Syncope
8%
Colitis ulcerative
8%
Nasopharyngitis
4%
Anaemia
4%
Rash
4%
Infusion related reaction
4%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
300 mg Spesolimab (BI 655130) SD
1200 mg Spesolimab (BI 655130) q4w
450 mg Spesolimab (BI 655130) q4w

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spesolimab
2016
Completed Phase 3
~700

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,534 Previous Clinical Trials
11,357,487 Total Patients Enrolled
~27 spots leftby Dec 2026
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