Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-16 @ 11:26 AM
Study NCT ID:
NCT04203433
Status:
COMPLETED
Last Update Posted:
2023-05-03
First Post:
2019-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of DLX105-DMP in Subjects With Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-30', 'studyFirstSubmitDate': '2019-12-16', 'studyFirstSubmitQcDate': '2019-12-16', 'lastUpdatePostDateStruct': {'date': '2023-05-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Tolerability Sensations', 'timeFrame': 'Up to 4 Weeks', 'description': '4-point likert scale: 0 = none, 1 = mild, 2 = moderate, or 3 = severe'}, {'measure': 'Local Site Application Assessment', 'timeFrame': 'Up to 4 Weeks', 'description': 'Investigator Assessment of Site Application Area using a 5-point scale: 0 = no visible reaction to 4 = severe erythema with induration/vesicles'}, {'measure': 'Adverse Events', 'timeFrame': 'Day 1 through End of Study (Up to 4 Weeks after Last Dose)', 'description': 'Treatment Emergent Adverse Events'}, {'measure': 'Local Investigator Global Assessment (IGA)', 'timeFrame': 'Day 1 through End of Study (Up to 4 Weeks after Last Dose)', 'description': 'Local Investigator Global Assessment of Target Lesion, using a 5-point scale: 0 = clear to 5 = severe'}, {'measure': 'Local Psoriasis Area Severity Index Sum of Scores (Local PASI SOS)', 'timeFrame': 'Day 1 through End of Study (Up to 4 Weeks after Last Dose)', 'description': 'Local Psoriasis Area Severity Index Total Score for the Target Lesion, total score of 0 to 12.'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic Parameters', 'timeFrame': 'Day 1, Day 15, and Day 25', 'description': 'DLX105 concentrations in samples collected over time'}, {'measure': 'Immunogenicity Testing', 'timeFrame': 'Up to 4 Weeks after Last Dose', 'description': 'Presence of antidrug antibodies and drug neutralizing antibodies in samples collected over time'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'A Pilot, Open-Label Study in Subjects with Mild-to-Moderate Plaque Psoriasis to Investigate the Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multidose Regimen of DLX105-DMP Administered to a Target Lesion'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Signed and dated informed consent.\n* Subjects aged 18-75 years.\n* Male subject, or if female, must be surgically sterile, post-menopausal, or using acceptable birth control.\n* Stable chronic mild-to-moderate plaque psoriasis.\n\nKey Exclusion Criteria:\n\n* Non-plaque-type psoriasis only (e.g., pustular, erythrodermic and guttate psoriasis, palmar, or plantar) at Screening.\n* Drug-induced psoriasis (i.e., new onset or exacerbation from beta-blockers, calcium channel inhibitors or lithium) within 3 months prior to Day 1.\n* Ongoing use of psoriasis treatments or inadequate duration of washout prior to Day 1'}, 'identificationModule': {'nctId': 'NCT04203433', 'briefTitle': 'A Study of DLX105-DMP in Subjects With Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'DelArrivo, Inc.'}, 'officialTitle': 'A Pilot, Open-Label Study in Subjects With Mild-to-Moderate Plaque Psoriasis to Investigate the Dosing Feasibility, Safety, Tolerability, and Preliminary Efficacy of a Four-Week Multi-dose Regimen of DLX105-DMP Administered to a Target Lesion', 'orgStudyIdInfo': {'id': 'DLX105-DMP-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DLX105-DMP Multi-Dose Twice Weekly', 'description': '4 Weeks of 1mg DLX105-DMP applied to a target lesion twice weekly', 'interventionNames': ['Drug: DLX105-DMP']}, {'type': 'EXPERIMENTAL', 'label': 'DLX105-DMP Multi-Dose Once Weekly', 'description': '4 Weeks of 1mg DLX105-DMP applied to a target lesion once weekly', 'interventionNames': ['Drug: DLX105-DMP']}], 'interventions': [{'name': 'DLX105-DMP', 'type': 'DRUG', 'description': '1mg applied to target lesion', 'armGroupLabels': ['DLX105-DMP Multi-Dose Once Weekly', 'DLX105-DMP Multi-Dose Twice Weekly']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30022', 'city': 'Alpharetta', 'state': 'Georgia', 'country': 'United States', 'facility': 'DelArrivo Investigational Site', 'geoPoint': {'lat': 34.07538, 'lon': -84.29409}}, {'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'DelArrivo Investigational Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'DelArrivo Investigational Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'DelArrivo Investigational Site', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no current plan to make individual participant data available to other researchers; however, if study results are published, then de-identified IPD may be made available in connection with the publication.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DelArrivo, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}