Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-29 @ 2:37 AM
Study NCT ID:
NCT06278350
Status:
COMPLETED
Last Update Posted:
2025-12-09
First Post:
2024-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 161}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-07', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-02-19', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects with at least 75% improvement in PASI', 'timeFrame': 'Day 1-Day 85', 'description': 'Percentage of subjects with at least 75% improvement in PASI from baseline at week 12 of treatment'}], 'secondaryOutcomes': [{'measure': 'Percentage of subjects with at least 75% improvement in PASI', 'timeFrame': 'Day 1-Day 56', 'description': 'Percentage of subjects with at least 75% improvement in PASI from baseline at weeks 4 and 8 of treatment;'}, {'measure': 'Percentage of subjects with at least 90% improvement in PASI', 'timeFrame': 'Day 1-Day 85', 'description': 'Percentage of subjects with at least 90% improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;'}, {'measure': 'Percentage of subjects with 100% improvement in PASI', 'timeFrame': 'Day 1-Day 85', 'description': 'Percentage of subjects with 100% improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;'}, {'measure': 'Percentage improvement in PASI', 'timeFrame': 'Day 1-Day 85', 'description': 'Percentage improvement in PASI from baseline at weeks 4, 8, and 12 of treatment;'}, {'measure': 'Percentage of subjects with a PGA', 'timeFrame': 'Day 1-Day 85', 'description': 'Percentage of subjects with a PGA score of 0 or 1 at weeks 4, 8, and 12 of treatment;'}, {'measure': 'The main PK parameters ：Time to maximum measured plasma concentration（Tmax）', 'timeFrame': 'Day 1-Day 85', 'description': 'The main PK parameters ：Time to maximum measured plasma concentration（Tmax）'}, {'measure': 'The main PK parameters ：Peak Plasma Concentration（Cmax)', 'timeFrame': 'Day 1-Day 85', 'description': 'The main PK parameters ：Peak Plasma Concentration（Cmax）'}, {'measure': 'The main PK parameters：Area under the plasma concentration versus time curve（AUC）', 'timeFrame': 'Day 1-Day 85', 'description': 'The main PK parameters：Area under the plasma concentration versus time curve（AUC）'}, {'measure': 'The main PK parameters：Vz/F (apparent volume of distribution)', 'timeFrame': 'Day 1-Day 85', 'description': 'The main PK parameters：Vz/F (apparent volume of distribution)'}, {'measure': 'The main PK parameters： Half-life（t1/2）', 'timeFrame': 'Day 1-Day 85', 'description': 'The main PK parameters： Half-life（t1/2）'}, {'measure': 'The main PK parameters： Mean Residence Time (MRT)', 'timeFrame': 'Day 1-Day 85', 'description': 'The main PK parameters： Mean Residence Time (MRT)'}, {'measure': 'The main PK parameters：CL/F (apparent clearance)', 'timeFrame': 'Day 1-Day 85', 'description': 'The main PK parameters：CL/F (apparent clearance)'}, {'measure': 'Weight and height will be combined to report BMI in kg/m^2', 'timeFrame': 'Day -28-Day 99', 'description': 'Weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Incidence and severity of AEs based on NCI CTCAE V5.0', 'timeFrame': 'Day -28-Day 99', 'description': 'Incidence and severity of AEs based on NCI CTCAE V5.0'}, {'measure': 'Incidence and severity of TEAEs based on NCI CTCAE V5.0', 'timeFrame': 'Day -28-Day 99', 'description': 'Incidence and severity of TEAEs based on NCI CTCAE V5.0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Plaque Psoriasis']}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, multicenter clinical trial in participants with moderate-to-severe plaque psoriasis .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject voluntarily takes part in the study after being fully informed,signs a written ICF, and agrees to follow procedures specified in the study protocol;\n2. Plaque psoriasis assessed by the investigator as suitable for systemic treatment and stable (defined as stable as no significant outbreak of morphological change or disease activity assessed by the investigator) for at least 6 months prior to signing informed consent;\n3. During the screening period and before taking the investigational drug for the first time, psoriatic surface area (BSA) ≥10%, PGA score ≥ 3, PASI score ≥ 12;\n4. Hematology, Blood chemistry and Urinalysis examination were basically normal.\n\nExclusion Criteria:\n\n1. Erythrodermic psoriasis, pustular psoriasis, guttate psoriasis, reverse psoriasis, drug-induced psoriasis;\n2. Have other skin lesions that affect the evaluation of treatment outcomes, such as eczema;\n3. History of herpes zoster/herpes simplex, or presence of herpes zoster/herpes simplex infection during the screening period;\n4. Have a history of tuberculosis, or active tuberculosis, or latent tuberculosis, or suspected clinical manifestations of tuberculosis infection;\n5. Other conditions that the investigator considers inappropriate for participation in the study.'}, 'identificationModule': {'nctId': 'NCT06278350', 'briefTitle': 'Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis', 'organization': {'class': 'INDUSTRY', 'fullName': 'InventisBio Co., Ltd'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of D-2570 in Participants With Moderate-to-Severe Plaque Psoriasis', 'orgStudyIdInfo': {'id': 'D2570-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D-2570 group 1', 'description': 'D-2570 group 1', 'interventionNames': ['Drug: D-2570']}, {'type': 'EXPERIMENTAL', 'label': 'D-2570 group 2', 'description': 'D-2570 group 2', 'interventionNames': ['Drug: D-2570']}, {'type': 'EXPERIMENTAL', 'label': 'D-2570 group 3', 'description': 'D-2570 group 3', 'interventionNames': ['Drug: D-2570']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'Placebo group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'D-2570', 'type': 'DRUG', 'description': 'Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group\n\n1, group 2, group 3 or placebo group.', 'armGroupLabels': ['D-2570 group 1', 'D-2570 group 2', 'D-2570 group 3']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Randomized in a 1:1:1:1 ratio through the randomization system, and assigned to D-2570 group\n\n1, group 2, group 3 or placebo group.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jianzhong Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Peking University People's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InventisBio Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}