A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis

Официальное название

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

Обзор

The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).

Вмешательства

• Препарат Bimekizumab
  Study participants will receive bimekizumab at pre-specified time points.
• Препарат Placebo
  Study participants will receive matching placebo at pre-specified time points.

Первичные конечные точки

• Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16 [Срок оценки: At Week 16]

Вторичные конечные точки (10)

• Palmoplantar Pustulosis Area Severity Index 50 (PPPASI50) response at Week 16 [Срок оценки: At Week 16]
• PPPASI75 response at Week 16 [Срок оценки: At Week 16]
• PPPASI90 response at Week 16 [Срок оценки: At Week 16]
• PPPASI50 response at Week 8 [Срок оценки: At Week 8]
• PPP-IGA 0/1 response at Week 8 [Срок оценки: At Week 8]
• Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16 [Срок оценки: From Baseline to Week 16]
• Change from Baseline in Numerical Rating Scale (NRS) - PPP Pain score in the palmoplantar areas at Week 16 [Срок оценки: From Baseline to Week 16]
• Incidence of treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-up (SFU) Period [Срок оценки: From Baseline (Day 1) until Safety Follow-Up (up to Week 117)]
• Incidence of serious TEAEs from Baseline to the end of the SFU Period [Срок оценки: From Baseline (Day 1) until Safety Follow-Up (up to Week 117)]
• Incidence of TEAEs leading to permanent discontinuation of study treatment from Baseline to the end of the SFU Period [Срок оценки: From Baseline (Day 1) until Safety Follow-Up (up to Week 117)]

Критерии участия

Критерии включения

• At least 18 years of age inclusive, at the time of signing the informed consent form (ICF)
• Have a palmoplantar pustulosis (PPP) diagnosis for at least 24 weeks prior to the Screening Visit
• Have PPPASI ≥12 at the Screening Visit and Baseline Visit
• Have PPP-IGA ≥3 at the Screening Visit and Baseline Visit
• Have pustules on the palms of the hands and/or soles of the feet at the Screening Visit and Baseline Visit, defined as pustule severity ≥2 and having more than 5 active pustules
• Participant must be a candidate for systemic therapy or phototherapy

Критерии исключения

• Has PPP symptoms which improve significantly between the Screening Visit and Baseline Visit, defined as a reduction in the PPPASI score
• Has the following: palmoplantar PSO (plaque PSO on palms/soles), guttate PSO, erythrodermic PSO (EP), generalized pustular PSO (GPP), Acrodermatitis continua of Hallopeau (ACH), atopic dermatitis, dyshidrotic eczema or chronic hand eczema.
• Has drug-induced PSO (eg, first onset or current exacerbation due to beta blockers, calcium channel inhibitors, lithium, or tumor necrosis factor \[TNF\] inhibitor) or drug-induced pustular PSO (eg, acute generalized exanthematous pustulosis, acute localized exanthematous pustulosis)
• Has cutaneous lesions that may interfere with the evaluation of the affected area and/or evaluation of the severity of PPP
• Is taking or has taken prohibited or restricted medications without meeting the mandatory discontinuation or stability period relative to the Baseline Visit
• Is taking or has ever taken an interleukin (IL)-17A/IL-17F inhibitor, including bimekizumab, or has participated in a bimekizumab investigational study

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 15 центров

• Ppp001 20357 — Пекин
• Ppp001 20137 — Чэнду
• Ppp001 20352 — Чэнду
• Ppp001 20350 — Чунцин
• Ppp001 20311 — Гуанчжоу
• Ppp001 20313 — Гуанчжоу
• Ppp001 20022 — Ханчжоу
• Ppp001 20193 — Ханчжоу
• … и ещё 7 центров

Польша · 13 центров

• Ppp001 40626 — Bialystok
• Ppp001 40637 — Gdansk
• Ppp001 40878 — Katowice
• Ppp001 40915 — Krakow
• Ppp001 40625 — Lodz
• Ppp001 40757 — Poznan
• Ppp001 40396 — Rzeszów
• Ppp001 40743 — Szczecin
• … и ещё 5 центров

Германия · 12 центров

• Ppp001 40875 — Ahaus
• Ppp001 40740 — Bad Bentheim
• Ppp001 40515 — Berlin
• Ppp001 40891 — Bielefeld
• Ppp001 40893 — Bochum
• Ppp001 40356 — Dresden
• Ppp001 40866 — Göttingen
• Ppp001 40249 — Kiel
• … и ещё 4 центра

South Korea · 11 центров

• Ppp001 20366 — Anyang-si
• Ppp001 20211 — Bucheon-si
• Ppp001 20214 — Busan
• Ppp001 20215 — Gwangju
• Ppp001 20367 — Jeonju
• Ppp001 20208 — Seongnam-si
• Ppp001 20104 — Seoul
• Ppp001 20216 — Seoul
• … и ещё 3 центра

Испания · 9 центров

• Ppp001 40750 — Alicante
• Ppp001 40266 — Badalona
• Ppp001 40885 — Granada
• Ppp001 40888 — Madrid
• Ppp001 40297 — Manises
• … и ещё 4 центра

Канада · 7 центров

• Ppp001 50233 — Barrie
• Ppp001 50354 — Calgary
• Ppp001 50749 — Fredericton
• Ppp001 50765 — London
• Ppp001 50740 — Québec
• Ppp001 50752 — Red Deer
• Ppp001 50750 — Surrey

США · 6 центров

• Ppp001 50754 — Birmingham
• Ppp001 50746 — Coral Gables
• Ppp001 50757 — Auburn Hills
• Ppp001 50745 — Columbus
• Ppp001 50202 — Fairborn
• Ppp001 50744 — Oklahoma City

Франция · 3 центра

• Ppp001 40067 — Lyon
• Ppp001 40874 — Nice
• Ppp001 40887 — Toulon

Венгрия · 3 центра

• Ppp001 40203 — Budapest
• Ppp001 40895 — Debrecen
• Ppp001 40894 — Orosháza

Италия · 3 центра

• Ppp001 40816 — Brescia
• Ppp001 40567 — Roma
• Ppp001 40830 — Rozzano

Великобритания · 3 центра

Список центров уточняется — проверьте первичный протокол.

Чехия · 1 центр

• Ppp001 40881 — Ústí nad Labem

Дания · 1 центр

• Ppp001 40886 — Hellerup

Идентификаторы

NCT: NCT07219420 · PPP001 · U1111-1322-7183 · 2024-520337-80-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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