EffisayilTM ON: An open-label, long term extension study to assess the safety and efficacy of spesolimab treatment in patients with Generalized Pustular Psoriasis (GPP)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509216-28-00

Acronym

1368-0025

Enrollment

Registered

2024-02-12

Start date

2019-05-27

Completion date

Unknown

Last updated

2025-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Pustular Psoriasis

Brief summary

Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment

Detailed description

The reoccurrence of a GPP flare defined by GPPGA, Time to first achievement of a GPPGA score of 0 or 1 in patients who received flare rescue treatment, A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit in patients who received flare rescue treatment, Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit in patients who received flare rescue treatment

Interventions

DRUGSpesolimab

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence of treatment emergent adverse events (TEAEs) up to week 252 of maintenance treatment	—

Secondary

Measure	Time frame
The reoccurrence of a GPP flare defined by GPPGA, Time to first achievement of a GPPGA score of 0 or 1 in patients who received flare rescue treatment, A GPPGA pustulation sub-score of 0 indicating no visible pustules, by visit in patients who received flare rescue treatment, Change from baseline in Psoriasis Symptom Scale (PSS) score, by visit in patients who received flare rescue treatment	—

Countries

Belgium, France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026