A Phase 3 interventional study of Bimekizumab and Placebo in Palmoplantar Pustulosis, sponsored by UCB Biopharma SRL. Recruiting at 91 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by UCB Biopharma SRL (part of UCB S.A.) · Phase 3, Interventional, and Treatment
Among 20 studies testing bimekizumab in Psoriasis — 4 open to participants now, 5 under way, 3 of them phase 3. bimekizumab · Psoriasis.
Among the 20 studies testing bimekizumab in Psoriasis, this one is the 5th largest by planned enrollment, is one of 2 that started in 2025, is one of 10 in phase 3, and was the 18th registered.
2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.
This study's planned enrollment of 320 is above the median of 75 across 1,565 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →4 of the 20 studies testing bimekizumab in Psoriasis are open now, in 12 countries. Each count lists the studies.
bimekizumab: first FDA approval 2023 (BIMZELX), first EMA approval 2021. What it is approved for, and how studies give it, is on its page →
Of the 174 Psoriasis studies recruiting now, 91 (52%) set no upper age limit and 67 (39%) stop at 75 or younger; 25 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →20 studies; the count open now beside each. This study's row is marked.
First in 2012; this study’s year is marked. 2 started in 2025.
Median enrollment 161 across the 20 interventional studies. Of the 15 that completed or were terminated, 12 (80%) have results posted.
15 of 20 have an industry lead sponsor. The 8 most frequent:
UCB Biopharma SRL is the lead sponsor of 129 studies on the registry; 17 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 50 (70%) have results posted.
17 studies in Psoriasis by UCB Biopharma SRL: 1 open now, 2 under way, 2 of them phase 3. Of 15 finished, 12 (80%) have results posted.
Among the 17 studies in Psoriasis by UCB Biopharma SRL, this one is the 6th largest by planned enrollment of the 16 interventional ones, is the only one that started in 2025, is one of 11 in phase 3, and was the 16th registered.
UCB Biopharma SRL’s Psoriasis studies by the year they started, since 2016.
None of the studies under way reaches primary completion within a year.
Among the 20 studies testing bimekizumab in Psoriasis, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among UCB Biopharma SRL’s 17 in Psoriasis:
The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects randomized to this arm will receive the bimekizumab dosing regimen for the entire duration of the study.
Drug: Bimekizumab
Subjects randomized to this arm will receive placebo during the initial treatment period before transitioning to bimekizumab in the maintenance treatment period.
Drug: Placebo
Study participants will receive bimekizumab at pre-specified time points.
Also known as: BIMZELX, UCB4940
Study participants will receive matching placebo at pre-specified time points.
Also known as: PLB
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.
Time frame: At Week 16
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.
Time frame: At Week 16
PPPASI75 response at Week 16
The PPPASI75 response is based on at least 75% improvement from baseline in the PPPASI score.
Time frame: At Week 16
PPPASI90 response at Week 16
The PPPASI90 response is based on at least 90% improvement from baseline in the PPPASI score.
Time frame: At Week 16
PPPASI50 response at Week 8
The PPPASI50 response is based on at least 50% improvement from baseline in the PPPASI score.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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: * Results in death * Is life-threatening * Requires inpatient hospitalization or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity * Is a congenital anomaly/birth defect * Other important medical events which based on medical or scientific judgement may jeopardise the patients, or may require medical or surgical intervention to prevent any of the above. 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.
Time frame: 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.
Time frame: From Baseline (Day 1) until Safety Follow-Up (up to Week 117)
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: 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.
Access criteria: 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.
Data sharing details ↗ · www.vivli.org
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Studies of the drug tested here: Bimekizumab