A study to learn how safe bimekizumab is and how well it works in adults with palmoplantar pustulosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UCB Biopharma

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

7 Jan 2026 → ongoing

Decision date (initial)

2025-12-02

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

External identifiers

EU CT number

2024-520337-80-00

WHO UTN

U1111-1322-7183

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Others, Efficacy, Safety

To evaluate the efficacy of bimekizumab compared with placebo in participants with PPP at Week 16.

Secondary objectives 1

1. • To evaluate the efficacy of bimekizumab compared with placebo on additional efficacy measures in participants with pulmoplantar pustulosis (PPP). • To evaluate the impact of bimekizumab on patient-reported outcomes (PROs) in participants with PPP at Week 16. • To assess the safety and tolerability of bimekizumab in participants with PPP from Baseline through the end of the Safety Follow-up (SFU) Period.

Conditions and MedDRA coding

Palmoplantar Pustulosis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Participant must be at least 18 years of age inclusive, at the time of signing the informed consent form (ICF).
2. Participant must have a palmoplantar pustulosis (PPP) diagnosis for at least 24 weeks prior to the Screening Visit.
3. Participant must have Palmoplantar Pustulosis Area Severity Index (PPPASI) ≥12 at the Screening Visit and Baseline Visit.
4. Participant must have palmoplantar pustulosis- Investigator Global Assessment (PPP-IGA) ≥3 at the Screening Visit and Baseline Visit.
5. Participant must 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 in at least 1 region and having more than 5 active white- yellow pustules across all regions.
6. Participant must be a candidate for systemic therapy or phototherapy.

Exclusion criteria 7

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 10

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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 6

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UCB Biopharma

Sponsor organisation

UCB Biopharma

Address

Researchdreef 60

City

Anderlecht

Postcode

1070

Country

Belgium

Scientific contact point

Organisation

UCB Biopharma

Contact name

UCB Cares

Public contact point

Organisation

UCB Biopharma

Contact name

UCB Cares

Third parties 14

Locations

8 EU/EEA countries · 59 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 51 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications