Effisayil® REP: An open-label, multicenter, single-arm, post-marketing trial (in select countries) to evaluate efficacy and safety and the impact of immunogenicity on efficacy, safety, and pharmacokinetics of spesolimab i.v. in treatment of patients with Generalized Pustular Psoriasis (GPP) presenting with a recurrent flare following their initial GPP flare treatment with spesolimab i.v.

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502128-38-00

Acronym

1368-0120

Enrollment

Registered

2023-10-04

Start date

2023-10-11

Completion date

Unknown

Last updated

2025-12-03

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

Achievement of a GPPGA pustulation subscore of 0 indicating no visible pustules at Week 1

Detailed description

Achievement of a GPPGA pustulation subscore of 0 or 1, with a ≥2-point reduction from baseline at Week 1. The baseline is the last measurement prior to the first dose of re-treatment with spesolimab i.v.

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Achievement of a GPPGA pustulation subscore of 0 indicating no visible pustules at Week 1	—

Secondary

Measure	Time frame
Achievement of a GPPGA pustulation subscore of 0 or 1, with a ≥2-point reduction from baseline at Week 1. The baseline is the last measurement prior to the first dose of re-treatment with spesolimab i.v.	—

Countries

Belgium, France, Germany, Italy, Spain

Outcome results