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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1322-7183 | Registry Identifier | WHO universal trial number (UTN) | |
| 2024-520337-80-00 | EU Trial (CTIS) Number |
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The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bimekizumab | Experimental | Subjects randomized to this arm will receive the bimekizumab dosing regimen for the entire duration of the study. |
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| Placebo | Placebo Comparator | Subjects randomized to this arm will receive placebo during the initial treatment period before transitioning to bimekizumab in the maintenance treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bimekizumab | Drug | Study participants will receive bimekizumab at pre-specified time points. |
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| Measure | Description | Time Frame |
|---|---|---|
| Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16 | PPP-IGA is an overall assessment by a physician regarding condition of skin lesions on the palms and the soles in PPP. The Investigator will assess the overall severity of PPP using the following 5-point scale: 0 = Clear; 1 = Almost clear; 2 = Mild ; 3 = Moderate; 4 = Severe. | At Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Palmoplantar Pustulosis Area Severity Index 50 (PPPASI50) response at Week 16 | The PPPASI50 response is based on at least 50% improvement from baseline in the PPPASI total score which assesses the severity of PPP skin lesions. The PPPASI evaluates 4 areas: right palm, left palm, right sole, and left sole which account for 20%, 20%, 30%, and 30%, respectively, of the total surface area of the palms or soles. Each palm and sole is evaluated for 3 characteristics: erythema, pustule, and desquamation. Each characteristic is rated on a 5-point severity scale, from 0 (none) to 4 (very severe). The percentage of area affected by PPP skin lesions is also evaluated for each palm and sole. The PPPASI total score ranges from 0 to 72, with a higher score indicating higher disease severity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| UCB Cares | Contact | +18445992273 | ucbcares@ucb.com |
| Name | Affiliation | Role |
|---|---|---|
| UCB Cares | 001 844 599 22733 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ppp001 50754 | Recruiting | Birmingham | Alabama | 35205 | United States | |
| Ppp001 50746 |
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
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| Placebo | Drug | Study participants will receive matching placebo at pre-specified time points. |
|
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| At Week 16 |
| PPPASI75 response at Week 16 | The PPPASI75 response is based on at least 75% improvement from baseline in the PPPASI score. | At Week 16 |
| PPPASI90 response at Week 16 | The PPPASI90 response is based on at least 90% improvement from baseline in the PPPASI score. | At Week 16 |
| PPPASI50 response at Week 8 | The PPPASI50 response is based on at least 50% improvement from baseline in the PPPASI score. | At Week 8 |
| PPP-IGA 0/1 response at Week 8 | PPP-IGA is an overall assessment by a physician regarding condition of skin lesions on the palms and the soles in PPP. | At Week 8 |
| Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16 | The DLQI is a skin disease-specific questionnaire aimed at the evaluation of how symptoms and treatment affect participants' health-related quality of life (HRQOL). This questionnaire asks participants 10 questions about symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. For each question, participants are asked to evaluate on a 4-point scale (from 0=Not at all to 3=Very much) to which extend their skin disease has affected their life over the last week. The DLQI total score ranges from 0 to 30 with higher scores indicating lower HRQOL. | From Baseline to Week 16 |
| Change from Baseline in Numerical Rating Scale (NRS) - PPP Pain score in the palmoplantar areas at Week 16 | The study participant will score the worst level of PPP skin pain over the past 24 hours on a 11-point NRS from "0=no skin pain" to "10=very severe skin pain. | From Baseline to Week 16 |
| Incidence of treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-up (SFU) Period | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP to the end of the SFU Period. | 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 | An SAE is any untoward medical occurrence that at any dose:
| 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 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Treatment-emergent AEs are defined as those AEs that have a start date on or following the first dose of IMP to the end of the SFU Period. This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason. | From Baseline (Day 1) until Safety Follow-Up (up to Week 117) |
| Recruiting |
| Coral Gables |
| Florida |
| 33134 |
| United States |
| Ppp001 50757 | Recruiting | Auburn Hills | Michigan | 48326 | United States |
| Ppp001 50745 | Recruiting | Columbus | Ohio | 43213 | United States |
| Ppp001 50202 | Recruiting | Fairborn | Ohio | 45324 | United States |
| Ppp001 50744 | Recruiting | Oklahoma City | Oklahoma | 73170 | United States |
| Ppp001 50233 | Recruiting | Barrie | Canada |
| Ppp001 50354 | Recruiting | Calgary | Canada |
| Ppp001 50749 | Recruiting | Fredericton | Canada |
| Ppp001 50765 | Recruiting | London | Canada |
| Ppp001 50740 | Recruiting | Québec | Canada |
| Ppp001 50752 | Recruiting | Red Deer | Canada |
| Ppp001 50750 | Recruiting | Surrey | Canada |
| Ppp001 20357 | Recruiting | Beijing | China |
| Ppp001 20137 | Recruiting | Chengdu | China |
| Ppp001 20352 | Recruiting | Chengdu | China |
| Ppp001 20350 | Recruiting | Chongqing | China |
| Ppp001 20311 | Recruiting | Guangzhou | China |
| Ppp001 20313 | Recruiting | Guangzhou | China |
| Ppp001 20022 | Recruiting | Hangzhou | China |
| Ppp001 20193 | Recruiting | Hangzhou | China |
| Ppp001 20344 | Recruiting | Jinan | China |
| Ppp001 20355 | Recruiting | Jinan | China |
| Ppp001 20345 | Recruiting | Shanghai | China |
| Ppp001 20184 | Recruiting | Shenzhen | China |
| Ppp001 20136 | Recruiting | Tianjin | China |
| Ppp001 20356 | Recruiting | Xi'an | China |
| Ppp001 20353 | Recruiting | Yinchuan | China |
| Ppp001 40881 | Recruiting | Ústí nad Labem | Czechia |
| Ppp001 40886 | Recruiting | Hellerup | Denmark |
| Ppp001 40067 | Recruiting | Lyon | France |
| Ppp001 40874 | Recruiting | Nice | France |
| Ppp001 40887 | Recruiting | Toulon | France |
| Ppp001 40875 | Recruiting | Ahaus | Germany |
| Ppp001 40740 | Recruiting | Bad Bentheim | Germany |
| Ppp001 40515 | Recruiting | Berlin | Germany |
| Ppp001 40891 | Recruiting | Bielefeld | Germany |
| Ppp001 40893 | Recruiting | Bochum | Germany |
| Ppp001 40356 | Recruiting | Dresden | Germany |
| Ppp001 40866 | Recruiting | Göttingen | Germany |
| Ppp001 40249 | Recruiting | Kiel | Germany |
| Ppp001 40892 | Recruiting | Lübeck | Germany |
| Ppp001 40747 | Recruiting | Mainz | Germany |
| Ppp001 40177 | Recruiting | Münster | Germany |
| Ppp001 40366 | Recruiting | Rostock | Germany |
| Ppp001 40203 | Recruiting | Budapest | Hungary |
| Ppp001 40895 | Recruiting | Debrecen | Hungary |
| Ppp001 40894 | Recruiting | Orosháza | Hungary |
| Ppp001 40816 | Recruiting | Brescia | Italy |
| Ppp001 40567 | Recruiting | Roma | Italy |
| Ppp001 40830 | Recruiting | Rozzano | Italy |
| Ppp001 40626 | Recruiting | Bialystok | Poland |
| Ppp001 40637 | Recruiting | Gdansk | Poland |
| Ppp001 40878 | Recruiting | Katowice | Poland |
| Ppp001 40915 | Recruiting | Krakow | Poland |
| Ppp001 40757 | Recruiting | Poznan | Poland |
| Ppp001 40396 | Recruiting | Rzeszów | Poland |
| Ppp001 40743 | Recruiting | Szczecin | Poland |
| Ppp001 40788 | Recruiting | Torun | Poland |
| Ppp001 40604 | Recruiting | Warsaw | Poland |
| Ppp001 40625 | Recruiting | Warsaw | Poland |
| Ppp001 40876 | Recruiting | Warsaw | Poland |
| Ppp001 40334 | Recruiting | Wroclaw | Poland |
| Ppp001 40862 | Recruiting | Wroclaw | Poland |
| Ppp001 20366 | Recruiting | Anyang-si | South Korea |
| Ppp001 20211 | Recruiting | Bucheon-si | South Korea |
| Ppp001 20214 | Recruiting | Busan | South Korea |
| Ppp001 20215 | Recruiting | Gwangju | South Korea |
| Ppp001 20367 | Recruiting | Jeonju | South Korea |
| Ppp001 20208 | Recruiting | Seongnam-si | South Korea |
| Ppp001 20104 | Recruiting | Seoul | South Korea |
| Ppp001 20216 | Recruiting | Seoul | South Korea |
| Ppp001 20351 | Recruiting | Seoul | South Korea |
| Ppp001 20354 | Recruiting | Seoul | South Korea |
| Ppp001 40750 | Recruiting | Alicante | Spain |
| Ppp001 40266 | Recruiting | Badalona | Spain |
| Ppp001 40885 | Recruiting | Granada | Spain |
| Ppp001 40888 | Recruiting | Madrid | Spain |
| Ppp001 40297 | Recruiting | Manises | Spain |
| Ppp001 40889 | Recruiting | Málaga | Spain |
| Ppp001 40230 | Recruiting | Valencia | Spain |
| Ppp001 40868 | Recruiting | Valencia | Spain |
| Ppp001 40113 | Recruiting | London | United Kingdom |
| Ppp001 40880 | Recruiting | London | United Kingdom |
| Ppp001 40108 | Recruiting | Salford | United Kingdom |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| D010520 | Aggressive Periodontitis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| C000625981 | bimekizumab |
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