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| Name | Class |
|---|---|
| Meiji Seika Pharma Co., Ltd. | INDUSTRY |
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This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DMB-3115 | Experimental | Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment |
|
| Stelara | Active Comparator | Patients randomized to receive Stelara at the beginning of the study will be re-randomized at Week 28 in a 1:1 ratio to either continue on Stelara or will be transitioned to receive DMB-3115 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DMB-3115 | Drug | 45mg or 90mg dose subcutaneous administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara | Percent change in the Psoriasis Area and Severity Index (PASI) score. PASI score is calculated by evaluating the severity of symptoms in each regions of the subject, and produces a numeric score ranging from 0 to 72. The higher the number, the more severe the symptoms. In general, a PASI score of 5 to 10 is considered moderate disease, and a score over 10 is considered severe. The primary endpoint of this clinical trial is % change in PASI, which has a value between 0 and 100, with 100 indicating complete disappearance of symptoms and 0 indicating no improvement in symptoms. If the patient's Baseline PASI score was 10, and 5 at the measurement period, it means that the patient showed 50% reduction. | Week 8 (For EMA) and 12 (For FDA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Sooner Research | Norman | Oklahoma | 73071 | United States | ||
| Jordan Valley Dermatology Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | DMB-3115 | Patients randomized to receive DMB-3115 at the beginning of the study and continued to receive the same treatment DMB-3115: 45mg or 90mg dose subcutaneous administration |
| FG001 | Stelara |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 (Week 1 to 28) |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 4, 2021 | Nov 2, 2023 |
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| Stelara |
| Drug |
45mg or 90mg dose subcutaneous administration |
|
| West Jordan |
| Utah |
| 84088 |
| United States |
Patients randomized to receive Stelara at the beginning of the study and re-randomized at Week 28 in a 1:1 ratio to continue on Stelara
Stelara: 45mg or 90mg dose subcutaneous administration
| FG002 | Switch to DMB-3115 | Patients randomized to receive Stelara at the beginning of the study and re-randomized at Week 28 in a 1:1 ratio to be transitioned to receive DMB-3115 DMB-3115: 45mg or 90mg dose subcutaneous administration Stelara: 45mg or 90mg dose subcutaneous administration |
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 (Week 28 to 52) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DMB-3115 | Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment DMB-3115: 45mg or 90mg dose subcutaneous administration |
| BG001 | Stelara | Patients randomized to receive Stelara at the beginning of the study will be re-randomized at Week 28 in a 1:1 ratio to either continue on Stelara or will be transitioned to receive DMB-3115 DMB-3115: 45mg or 90mg dose subcutaneous administration Stelara: 45mg or 90mg dose subcutaneous administration |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | • To Evaluate Efficacy of DMB-3115 in Comparison With Stelara | Percent change in the Psoriasis Area and Severity Index (PASI) score. PASI score is calculated by evaluating the severity of symptoms in each regions of the subject, and produces a numeric score ranging from 0 to 72. The higher the number, the more severe the symptoms. In general, a PASI score of 5 to 10 is considered moderate disease, and a score over 10 is considered severe. The primary endpoint of this clinical trial is % change in PASI, which has a value between 0 and 100, with 100 indicating complete disappearance of symptoms and 0 indicating no improvement in symptoms. If the patient's Baseline PASI score was 10, and 5 at the measurement period, it means that the patient showed 50% reduction. | Per protocol set for EMA, Intention-to-Treat set for FDA | Posted | Least Squares Mean | Standard Error | percent change in PASI score | Week 8 (For EMA) and 12 (For FDA) |
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Focused primarily on treatment-emergent AEs (TEAEs), i.e., a new event that occurred during or after first dose of study treatment or any event present at baseline that worsened in either intensity or frequency after first dose of study treatment. The AEs are collected from subject's signing of informed consent until the last visit of subject, up to 57 weeks.
Note that one patient of DMB-3115 group has completed period 1 and started period 2, but right after re-randomization, the subject has been withdrawn.
So, 268 subjects of DMB-3115 group has started period 2 but the AEs are collected with 267 subjects.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DMB-3115 (Period 1) | Patients randomized to receive DMB-3115 at the beginning of the study DMB-3115: 45mg or 90mg dose subcutaneous administration | 2 | 299 | 5 | 299 | 73 | 299 |
| EG001 | Stelara (Period 1) | Patients randomized to receive Stelara at the beginning of the study Stelara: 45mg or 90mg dose subcutaneous administration | 1 | 299 | 3 | 299 | 90 | 299 |
| EG002 | DMB-3115 (Period 2) | Patients randomized to receive DMB-3115 at the beginning of the study and continued to receive the same treatment DMB-3115: 45mg or 90mg dose subcutaneous administration | 0 | 267 | 0 | 267 | 17 | 267 |
| EG003 | Stelara (Period 2) | Patients randomized to receive Stelara at the beginning of the study and re-randomized at Week 28 in a 1:1 ratio to continue on Stelara Stelara: 45mg or 90mg dose subcutaneous administration | 0 | 132 | 2 | 132 | 15 | 132 |
| EG004 | Switch to DMB-3115 (Period 2) | Patients randomized to receive Stelara at the beginning of the study and re-randomized at Week 28 in a 1:1 ratio to be transitioned to receive DMB-3115 DMB-3115: 45mg or 90mg dose subcutaneous administration Stelara: 45mg or 90mg dose subcutaneous administration | 0 | 131 | 0 | 131 | 11 | 131 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Sudden cardiac death | General disorders | MedDRA 25.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
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| COVID-19 pneumonia | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Intervertebral disc disorder | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.1 | Non-systematic Assessment |
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| Vith nerve paralysis | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Dong-A ST | 02-920-1111 | imspring@donga.co.kr |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 21, 2022 | Nov 8, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| Male |
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| Ethnicity : Not Hispanic or Latino |
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| Ethnicity : Unknown |
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| Black or African American |
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| White |
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| Not Reported |
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| Europe |
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| Georgia |
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| Ukraine |
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| Week 12 (for FDA) |
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