Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-02-23 @ 6:27 AM
Study NCT ID:
NCT02529956
Status:
COMPLETED
Last Update Posted:
2015-08-20
First Post:
2015-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of UCB4940 in Patients With Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011565', 'term': 'Psoriasis'}], 'ancestors': [{'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625981', 'term': 'bimekizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-19', 'studyFirstSubmitDate': '2015-08-19', 'studyFirstSubmitQcDate': '2015-08-19', 'lastUpdatePostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of subjects reporting at least 1 Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks)', 'timeFrame': 'Baseline to 20 Weeks'}, {'measure': 'Number of subjects prematurely discontinuing due to a Treatment-Emergent Adverse Event (TEAE) during the Treatment Period (20 Weeks)', 'timeFrame': 'Baseline to 20 Weeks'}, {'measure': 'Number of subjects reporting at least 1 Serious Adverse Event (SAE) during the Treatment Period (20 Weeks)', 'timeFrame': 'Baseline to 20 Weeks'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax)', 'timeFrame': 'Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20'}, {'measure': 'Area under the plasma concentration-time curve from time 0 to infinity (AUC(0-inf))', 'timeFrame': 'Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20'}, {'measure': 'Area under the plasma concentration-time curve from time 0 to the time of last quantifiable concentration (AUC(0-t))', 'timeFrame': 'Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20'}, {'measure': 'Time to reach Cmax (Tmax)', 'timeFrame': 'Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20'}, {'measure': 'Terminal elimination half-life (t1/2)', 'timeFrame': 'Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20'}, {'measure': 'First order terminal elimination rate constant (λz)', 'timeFrame': 'Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20'}, {'measure': 'Total body clearance (CL)', 'timeFrame': 'Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20'}, {'measure': 'Volume of distribution in terminal phase (Vz)', 'timeFrame': 'Pharmacokinetic samples will be taken predose and 0-48 hr post-dose, 72 hr post-dose, 96 hr post-dose, Week-1 through Week-20'}, {'measure': 'Percentage Change from Baseline to Week 12 in the Lesion Severity Score (LSS)', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Percentage Change from Baseline to Week 12 in thickness of the plaque', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Percentage Change from Baseline to Week 12 in lesion area', 'timeFrame': 'Baseline to Week 12'}, {'measure': 'Percentage Change from Baseline to Week 12 in Psoriasis Area and Severity Index (PASI)', 'timeFrame': 'Baseline to Week 12'}, {'measure': "Percentage Change from Baseline to Week 12 in Physician's Global Assessment (PGA)", 'timeFrame': 'Baseline to Week 12'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Psoriasis', 'UCB4940'], 'conditions': ['Mild to Moderate Psoriasis']}, 'referencesModule': {'references': [{'pmid': '27859546', 'type': 'DERIVED', 'citation': 'Glatt S, Helmer E, Haier B, Strimenopoulou F, Price G, Vajjah P, Harari OA, Lambert J, Shaw S. First-in-human randomized study of bimekizumab, a humanized monoclonal antibody and selective dual inhibitor of IL-17A and IL-17F, in mild psoriasis. Br J Clin Pharmacol. 2017 May;83(5):991-1001. doi: 10.1111/bcp.13185. Epub 2017 Jan 10.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the safety of UCB4940 administered by iv infusion of a single ascending dose in subjects with mild to moderate plaque psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Subject is male or female, aged ≥ 18 years to ≤ 70 years at Screening. Female subjects must either be postmenopausal (at least 1 year), permanently sterilized or, if of childbearing potential, must be willing to use at least 2 effective methods of contraception, including a barrier method during the study period. Effective methods of contraception are methods of birth control, which result in a low failure rate when used consistently and correctly, such as implants, injectables, oral contraceptives, progesterone-releasing intrauterine systems or the TCu 380A intrauterine device, complete sexual abstinence, or vasectomized partner. Male subjects with partners of childbearing potential must be willing to use a condom when sexually active. Both male and female subjects must use the above mentioned contraception for 20 weeks after administration of study drug (anticipated 5 half-lives)\n* Subject has had a confirmed diagnosis of mild to moderate plaque-type psoriasis for at least 6 months involving ≤ 5 % of body surface area (BSA) (excluding the scalp)\n* Subject has a body mass index of ≤ 35 kg/m\\^2 at Screening\n* Subject has a minimum of 2 psoriatic lesions with at least 1 plaque in a site suitable for biopsy\n\nExclusion Criteria:\n\n* Female subject who is pregnant, or plans to become pregnant during the study, or lactating, or sexually active with childbearing potential who is not using a medically accepted birth control method\n* Subject has received systemic nonbiologic psoriasis therapy (methotrexate \\[MTX\\], steroids, cyclophosphamide) or psoralen plus ultraviolet A (PUVA)/ultraviolet A (UVA) phototherapy within 4 weeks prior to Screening\n* Subject has received treatment with biologic agents within 12 months prior to the study\n* Subject has received live attenuated vaccination within 6 weeks prior to Screening or intends to have such a vaccination during the course of the study\n* Subject has received any investigational drug or experimental procedure within 90 days or 5 half-lives, whichever is longer, prior to IMP administration\n* Subject requires treatment with a nonsteroidal anti-inflammatory drug during the study period. Paracetamol will be permitted for use as an antipyretic and/or analgesic\n* Subject has an active infection (eg, sepsis, pneumonia, abscess) or has had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to IMP administration. When in doubt, the Investigator should confer with the UCB Study Physician\n* Subject has a history of a positive tuberculosis (TB) test or evidence of possible TB or latent TB infection at Screening that cannot be attributed to a prior Bacillus Calmette-Guérin inoculation\n* Subject has renal or liver impairment, defined as:\n\n * For women, serum creatinine level ≥ 125 μmol/L; for men, ≥ 135 μmol/L, or\n * ALT and aspartate aminotransferase ≥ 2x ULN, or\n * Alkaline phosphatase and bilirubin \\> 1.5x ULN (an isolated bilirubin \\> 1.5x ULN is acceptable if bilirubin is fractionated and direct bilirubin is \\< 35 %)\n* Subject has active neoplastic disease or history of neoplastic disease within 5 years of Screening (except for basal or squamous cell carcinoma of the skin or carcinoma in situ that has been definitively treated with standard of care)'}, 'identificationModule': {'nctId': 'NCT02529956', 'briefTitle': 'A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of UCB4940 in Patients With Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Randomized, Subject-blind, Investigator-blind, Placebo-controlled, Single-dose, Dose-escalating Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of UCB4940 in Patients With Mild to Moderate Psoriasis', 'orgStudyIdInfo': {'id': 'UP0008'}, 'secondaryIdInfos': [{'id': '2012-002086-35', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UCB4940 8 mg', 'description': 'Single intravenous (iv) infusion of UCB4940 8 mg over at least 60 minutes.', 'interventionNames': ['Drug: UCB4940']}, {'type': 'EXPERIMENTAL', 'label': 'UCB4940 40 mg', 'description': 'Single intravenous (iv) infusion of UCB4940 40 mg over at least 60 minutes.', 'interventionNames': ['Drug: UCB4940']}, {'type': 'EXPERIMENTAL', 'label': 'UCB4940 160 mg', 'description': 'Single intravenous (iv) infusion of UCB4940 160 mg over at least 60 minutes.', 'interventionNames': ['Drug: UCB4940']}, {'type': 'EXPERIMENTAL', 'label': 'UCB4940 480 mg', 'description': 'Single intravenous (iv) infusion of UCB4940 480 mg over at least 60 minutes.', 'interventionNames': ['Drug: UCB4940']}, {'type': 'EXPERIMENTAL', 'label': 'UCB4940 640 mg', 'description': 'Single intravenous (iv) infusion of UCB4940 640 mg over at least 60 minutes.', 'interventionNames': ['Drug: UCB4940']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Single intravenous (iv) infusion of Placebo over at least 60 minutes.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'UCB4940', 'type': 'DRUG', 'description': '* Active Substance: UCB4940\n* Pharmaceutical Form: Solution for infusion\n* Concentration: 80 mg/ml\n* Route of Administration: Intravenous use', 'armGroupLabels': ['UCB4940 160 mg', 'UCB4940 40 mg', 'UCB4940 480 mg', 'UCB4940 640 mg', 'UCB4940 8 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': '* Active Substance: Placebo\n* Pharmaceutical Form: Solution for infusion\n* Concentration: 0.9 % sodium chloride aqueous solution\n* Route of Administration: Intravenous use', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Harrow', 'country': 'United Kingdom', 'facility': '1', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}], 'overallOfficials': [{'name': 'UCB Clinical Trial Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': '+1 877 8229493 (UCB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Celltech', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}