Ignite Creation Date:
2025-12-24 @ 2:42 PM
Ignite Modification Date:
2025-12-25 @ 12:11 PM
Study NCT ID:
NCT06630559
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-10-08
First Post:
2024-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients with Moderate to Severe Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 375}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-07', 'studyFirstSubmitDate': '2024-10-07', 'studyFirstSubmitQcDate': '2024-10-07', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change from baseline in Psoriasis Area and Severity Index (PASI) score', 'timeFrame': 'Week 12'}], 'secondaryOutcomes': [{'measure': 'Actual PASI scores', 'timeFrame': 'Up to 56 Weeks'}, {'measure': 'Percent change from baseline in PASI score', 'timeFrame': 'Up to 56 Weeks'}, {'measure': 'Proportion of patients who achieve at least 50/75/90/100% improvement from baseline in PASI (PASI 50/75/90/100)', 'timeFrame': 'Up to 56 Weeks'}, {'measure': 'Proportion of patients with IGA score of clear (0) or almost clear (1)', 'timeFrame': 'Up to 56 Weeks'}, {'measure': 'Change from baseline in Dermatology Life Quality Index (DLQI)', 'timeFrame': 'Up to 56 Weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'The goal of this Phase 3 clinical trial is to compare efficacy and safety of CT-P55 with Cosentyx in patients with moderate to severe plaque psoriasis', 'detailedDescription': 'CT-P55 is a recombinant humanized monoclonal antibody containing the active ingredient secukinumab. CT-P55 is a drug product being developed by CELLTRION, Inc. and being compared to both the EU-approved Cosentyx®. In this study, Efficacy and Safety of CT-P55 will be evaluated in patients with Moderate to Severe Chronic Plaque Psoriasis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patient has had a diagnosis of chronic plaque psoriasis for at least 24 weeks.\n\nExclusion Criteria:\n\n* Patient diagnosed with forms of psoriasis other than chronic plaque-type or medication-induced psoriasis.\n* Patient who has previously received Secukinumab or any other biologic drug directly targeting Interleukin-17 or the IL-17 receptor.\n* Patient who has allergies to any of the excipients of study drug or materials of device or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.'}, 'identificationModule': {'nctId': 'NCT06630559', 'briefTitle': 'A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients with Moderate to Severe Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celltrion'}, 'officialTitle': 'A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P55 with Cosentyx in Patients with Moderate to Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'CT-P55 3.1'}, 'secondaryIdInfos': [{'id': '2024-513348-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-P55', 'interventionNames': ['Biological: CT-P55']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'EU-approved Cosentyx', 'interventionNames': ['Biological: CT-P55', 'Biological: EU-approved Cosentyx']}], 'interventions': [{'name': 'CT-P55', 'type': 'BIOLOGICAL', 'description': 'CT-P55, 300 mg by 2 subcutaneous (SC) injections of 150 mg/mL via Pre-Filled Syringe (PFS) every week for 5 doses (up to Week 4 after starting dose at Day 1), followed by every 4 weeks (Q4W) for 11doses (up to Week 48).', 'armGroupLabels': ['CT-P55', 'EU-approved Cosentyx']}, {'name': 'EU-approved Cosentyx', 'type': 'BIOLOGICAL', 'description': 'European Union (EU)-approved Cosentyx, 300 mg by 2 SC injections of 150 mg/mL via PFS every week for 5 doses (up to Week 4 after starting dose at Day 1), followed by Q4W for 11 doses (up to Week 48).', 'armGroupLabels': ['EU-approved Cosentyx']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jihyun Yoon', 'role': 'CONTACT', 'email': 'jihyun.yoon@celltrion.com', 'phone': '+82-32-850-5768'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celltrion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}