A Study to Test Whether BI 655130 (Spesolimab) Prevents Flare-ups in Patients With Generalized Pustular Psoriasis
Summary
This is a study in adolescents and adults with Generalized Pustular Psoriasis (GPP). People between 12 and 75 years old can take part in the study. The study is open to people who had GPP flare-ups in the past but whose skin is clear or almost clear when they join the study. The purpose of the study is to test 3 different doses of a medicine called spesolimab and to see whether it helps to prevent GPP flare-ups. Participants are put into 4 groups by chance. Three groups get different doses of spesolimab. The fourth group gets a placebo. Placebo looks like spesolimab but does not contain any medicine. Spesolimab and placebo are given as an injection under the skin. Participants are in the study for about 1 year and 4 months. During this time, they visit the study site about 15 times. For the first 11 months, participants get spesolimab or placebo injections every month. At the study visits, the doctors check participants' skin for signs of a new GPP flare-up. The doctors also check the general health of the participants. If a participant has a GPP flare-up during the study, more visits may be necessary. In case of a flare-up, participants get a dose of spesolimab as an infusion into a vein.
Timeline
- Start
- 2020-06-04
- Primary completion
- 2022-11-23
- Completion
- 2022-11-23
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs Spesolimab SC High Dose; p = 0.0005; Hazard Ratio (HR) 0.157 (95% CI 0.046 to 0.541); Log Rank NCT04399837 ↗
registry analysis (other test); Placebo vs Spesolimab SC Low Dose vs Spesolimab SC Medium Dose vs Spesolimab SC High Dose; p = 0.002; Multiple contrast test 3.041; MCP-Mod linear model fit NCT04399837 ↗
release “EFFISAYIL ® 2: A Phase IIb study that showed spesolimab significantly reduced the risk of GPP flares by 84% over 48 weeks compared to placebo” prnewswire.com ↗
Publications
- Gordon KB, Augustin M, Barker J, Tada Y, Lebwohl MG, Tang M, Hofmann P, Thoma C, Gottlieb AB. Effect of spesolimab on sustained disease control in patients with generalized pustular psoriasis: Post hoc analysis of the EFFISAYIL 2 study. J Am Acad Dermatol. 2025 Jun;92(6):1235-1242. doi: 10.1016/j.jaad.2025.01.089. Epub 2025 Mar 7.
- Morita A, Choon SE, Bachelez H, Anadkat MJ, Marrakchi S, Zheng M, Tsai TF, Turki H, Hua H, Rajeswari S, Thoma C, Burden AD. Design of Effisayil 2: A Randomized, Double-Blind, Placebo-Controlled Study of Spesolimab in Preventing Flares in Patients with Generalized Pustular Psoriasis. Dermatol Ther (Heidelb). 2023 Jan;13(1):347-359. doi: 10.1007/s13555-022-00835-6. Epub 2022 Nov 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Spesolimab | Monoclonal antibody | 150 mg | Subcutaneous |
| Subject | Spesolimab | Monoclonal antibody | 300 mg | Subcutaneous |