Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis

Birmingham, AL

Phase 2

Waitlist Available

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from start of treatment until day 7, up to 7 days.

Summary

To evaluate efficacy, safety, and tolerability of spesolimab (BI 655130) compared to placebo in patients with Generalized Pustular Psoriasis (GPP) presenting with an acute flare of moderate to severe intensity.

Eligible Conditions

Pustular Psoriasis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from start of treatment until day 7, up to 7 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from start of treatment until day 7, up to 7 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of treatment until day 7, up to 7 days. for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Proportion of Patients With a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) Pustulation Subscore of 0 Indicating no Visible Pustules at Week 1

Secondary study objectives

Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Score at Week 4

Change From Baseline in Pain Visual Analog Scale (VAS) Score at Week 4

Change From Baseline in Psoriasis Symptom Scale (PSS) Score at Week 4

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