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A phase 3, randomized, double-blind, placebo-controlled, multicenter study with open-label extension to evaluate the efficacy and safety of bimekizumab in study participants with palmoplantar pustulosis

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-520337-80-00
Acronym
PPP001
Enrollment
190
Registered
2025-12-02
Start date
2026-01-07
Completion date
Unknown
Last updated
2025-12-17

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

Conditions

Palmoplantar Pustulosis

Brief summary

Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16

Detailed description

Palmoplantar Pustulosis Area Severity Index 50 (PPPASI50) response at Week 16, PPPASI75 response at Week 16, PPPASI90 response at Week 16, PPPASI50 response at Week 8, PPP-IGA 0/1 response at Week 8, Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16, Change from Baseline in Numerical Rating Scale (NRS) – PPP Pain score in the palmoplantar areas at Week 16, Incidence of treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-up (SFU) Period, Incidence of serious TEAEs from Baseline to the end of the SFU Period, Incidence of TEAEs leading to permanent discontinuation of study treatment from Baseline to the end of the SFU Period

Interventions

DRUGBimzelx 160 mg solution for injection in pre-filled syringe
DRUGBimzelx 320 mg solution for injection in pre-filled pen
DRUGPlacebo matching test. 0.9% sodium chloride solution for injection (unauthorized).

Sponsors

UCB Biopharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16—

Secondary

MeasureTime frame
Palmoplantar Pustulosis Area Severity Index 50 (PPPASI50) response at Week 16, PPPASI75 response at Week 16, PPPASI90 response at Week 16, PPPASI50 response at Week 8, PPP-IGA 0/1 response at Week 8, Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16, Change from Baseline in Numerical Rating Scale (NRS) – PPP Pain score in the palmoplantar areas at Week 16, Incidence of treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-up (SFU) Period, Incidence of serious TEAEs from Baseline to the end of the SFU Period, Incidence of TEAEs leading to permanent discontinuation of study treatment from Baseline to the end of the SFU Period—

Countries

Czechia, Denmark, France, Germany, Hungary, Italy, Poland, Spain

Outcome results

None listed

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