Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT07219420
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D010520', 'term': 'Aggressive Periodontitis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625981', 'term': 'bimekizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-11-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2029-10-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-10-17', 'studyFirstSubmitQcDate': '2025-10-17', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Palmoplantar pustulosis-Investigator Global Assessment 0/1 (PPP-IGA 0/1) response at Week 16', 'timeFrame': 'At Week 16', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Palmoplantar Pustulosis Area Severity Index 50 (PPPASI50) response at Week 16', 'timeFrame': 'At Week 16', 'description': '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.\n\nThe 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:\n\nerythema, 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.\n\nThe PPPASI total score ranges from 0 to 72, with a higher score indicating higher disease severity.'}, {'measure': 'PPPASI75 response at Week 16', 'timeFrame': 'At Week 16', 'description': 'The PPPASI75 response is based on at least 75% improvement from baseline in the PPPASI score.'}, {'measure': 'PPPASI90 response at Week 16', 'timeFrame': 'At Week 16', 'description': 'The PPPASI90 response is based on at least 90% improvement from baseline in the PPPASI score.'}, {'measure': 'PPPASI50 response at Week 8', 'timeFrame': 'At Week 8', 'description': 'The PPPASI50 response is based on at least 50% improvement from baseline in the PPPASI score.'}, {'measure': 'PPP-IGA 0/1 response at Week 8', 'timeFrame': 'At Week 8', 'description': 'PPP-IGA is an overall assessment by a physician regarding condition of skin lesions on the palms and the soles in PPP.'}, {'measure': 'Change from Baseline in Dermatology Life Quality Index (DLQI) total score at Week 16', 'timeFrame': 'From Baseline to Week 16', 'description': "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."}, {'measure': 'Change from Baseline in Numerical Rating Scale (NRS) - PPP Pain score in the palmoplantar areas at Week 16', 'timeFrame': 'From Baseline to Week 16', 'description': '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.'}, {'measure': 'Incidence of treatment-emergent adverse events (TEAEs) from Baseline to the end of the Safety Follow-up (SFU) Period', 'timeFrame': 'From Baseline (Day 1) until Safety Follow-Up (up to Week 112)', 'description': '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 through the final dose of IMP + 12 weeks.'}, {'measure': 'Incidence of serious TEAEs from Baseline to the end of the SFU Period', 'timeFrame': 'From Baseline (Day 1) until Safety Follow-Up (up to Week 112)', 'description': 'An SAE is any untoward medical occurrence that at any dose:\n\n* Results in death\n* Is life-threatening\n* Requires inpatient hospitalization or prolongation of existing hospitalization\n* Results in persistent or significant disability/incapacity\n* Is a congenital anomaly/birth defect\n* 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 through the final dose of IMP + 12 weeks.'}, {'measure': 'Incidence of TEAEs leading to permanent discontinuation of study treatment from Baseline to the end of the SFU Period', 'timeFrame': 'From Baseline (Day 1) until Safety Follow-Up (up to Week 112)', 'description': '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 through the final dose of IMP + 12 weeks. This measure considers any TEAE leading to permanent discontinuation of IMP regardless of reason.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bimekizumab, PPP'], 'conditions': ['Palmoplantar Pustulosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of bimekizumab compared with placebo in participants with palmoplantar pustulosis (PPP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 18 years of age inclusive, at the time of signing the informed consent form (ICF)\n* Have a palmoplantar pustulosis (PPP) diagnosis for at least 24 weeks prior to the Screening Visit\n* Have PPPASI ≥12 at the Screening Visit and Baseline Visit\n* Have PPP-IGA ≥3 at the Screening Visit and Baseline Visit\n* 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\n* Participant must be a candidate for systemic therapy or phototherapy\n\nExclusion Criteria:\n\n* Has PPP symptoms which improve significantly between the Screening Visit and Baseline Visit, defined as a reduction in the PPPASI score\n* 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.\n* 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)\n* Has cutaneous lesions that may interfere with the evaluation of the affected area and/or evaluation of the severity of PPP\n* Is taking or has taken prohibited or restricted medications without meeting the mandatory discontinuation or stability period relative to the Baseline Visit\n* Is taking or has ever taken an interleukin (IL)-17A/IL-17F inhibitor, including bimekizumab, or has participated in a bimekizumab investigational study'}, 'identificationModule': {'nctId': 'NCT07219420', 'acronym': 'BeSeen', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Bimekizumab in Study Participants With Palmoplantar Pustulosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PPP001'}, 'secondaryIdInfos': [{'id': 'U1111-1322-7183', 'type': 'REGISTRY', 'domain': 'WHO universal trial number (UTN)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bimekizumab', 'description': 'Subjects randomized to this arm will receive the bimekizumab dosing regimen for the entire duration of the study.', 'interventionNames': ['Drug: Bimekizumab']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects randomized to this arm will receive placebo during the initial treatment period before transitioning to bimekizumab in the maintenance treatment period.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bimekizumab', 'type': 'DRUG', 'otherNames': ['BIMZELX, UCB4940'], 'description': 'Study participants will receive bimekizumab at pre-specified time points.', 'armGroupLabels': ['Bimekizumab']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['PLB'], 'description': 'Study participants will receive matching placebo at pre-specified time points.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Québec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Ppp001 50740', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Guangzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Ppp001 20313', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Hangzhou', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Ppp001 20022', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Ppp001 20345', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'UCB Cares', 'role': 'CONTACT', 'email': 'ucbcares@ucb.com', 'phone': '+18445992273'}], 'overallOfficials': [{'name': 'UCB Cares', 'role': 'STUDY_DIRECTOR', 'affiliation': '001 844 599 22733 (UCB)'}]}, 'ipdSharingStatementModule': {'url': 'http://www.Vivli.org', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': '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.', 'ipdSharing': 'YES', '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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Biopharma SRL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}