Trials / Completed
CompletedNCT03782792
Effisayil™ 1: A Study to Test Spesolimab (BI 655130) in Patients With a Flare-up of a Skin Disease Called Generalized Pustular Psoriasis
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 53 (actual)
- Sponsor
- Boehringer Ingelheim · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Spesolimab | Solution for infusion |
| DRUG | Placebo | Solution for infusion |
Timeline
- Start date
- 2019-01-31
- Primary completion
- 2020-09-23
- Completion
- 2021-01-05
- First posted
- 2018-12-20
- Last updated
- 2025-10-16
- Results posted
- 2022-03-09
Locations
37 sites across 12 countries: United States, China, France, Germany, Japan, Malaysia, Singapore, South Korea, Switzerland, Taiwan, Thailand, Tunisia
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03782792. Inclusion in this directory is not an endorsement.