At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 53 enrolled
Drug / intervention
Spesolimab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effisayil™ 1:Multi-center, Double-blind, Randomised, Placebo-controlled, Phase II Study to Evaluate Efficacy, Safety and Tolerability of a Single Intravenous Dose of Spesolimab (BI 655130) in Patients With Generalized Pustular Psoriasis (GPP) Presenting With an Acute Flare of Moderate to Severe Intensity
In Brief
A Phase 2 clinical trial evaluating Spesolimab and Placebo for Generalized Pustular Psoriasis. Completed, enrolled 53 participants across 37 sites in 12 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGeneralized Pustular Psoriasis
CountriesChina, France, Germany, Japan, Malaysia, Singapore, South Korea, Switzerland, Taiwan, Thailand, Tunisia, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedDec 2018
Enrollment StartJan 2019
Primary CompletionSep 2020
Study CompletionJan 2021
TodayJul 2026
First PostedDec 20, 2018
Enrollment StartJan 31, 2019
Primary CompletionSep 23, 2020
Study CompletionJan 5, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.5 years ago
Interventions
Spesolimabdrug
Solution for infusion
Placebodrug
Solution for infusion