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Spesolimab for Pustular Psoriasis
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.
Awards & highlights
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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of Patients With a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) Pustulation Subscore of 0 Indicating no Visible Pustules at Week 1
Secondary outcome measures
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
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: SpesolimabExperimental Treatment1 Intervention
Group II: PlaceboExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spesolimab
2016
Completed Phase 3
~700
Placebo
1995
Completed Phase 3
~2670
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Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,534 Previous Clinical Trials
11,357,474 Total Patients Enrolled
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