Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a randomised, double-blind, multicentre clinical study to evaluate the efficacy, safety, tolerability, PK, and immunogenicity of SB17 compared to Stelara® in subjects with moderate to severe plaque psoriasis.
Subjects will be randomised in a 1:1 ratio to receive either SB17 or Stelara® via subcutaneous injection. At Week 28, subjects receiving Stelara® will be randomised again in a 1:1 ratio to either continue on Stelara® or be transitioned to SB17. Investigational products (IPs) (SB17 or Stelara®) will be administered at Week 0, 4, and then every 12 weeks up to Week 40, and the last assessment will be done at Week 52.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SB17 (Proposed Ustekinumab Biosimilar) | Experimental |
| |
| Stelara® (Ustekinumab) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stelara® (Ustekinumab) | Drug | Subjects randomised into Stelara® group will receive Stelara® (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in PASI at Week 12 | Psoriasis area severity index (PASI) measures the activity of psoriasis through erythema, induration and scaling and can range from 0 to 72. The degree of PASI improvement in terms of percent change from baseline at Week 12 is measured. | Baseline and Week 12 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SB Investigative Site | Brno | Czechia | ||||
| SB Investigative Site |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | SB17 (Proposed Ustekinumab Biosimilar) | Subjects were randomised into SB17 (Proposed Ustekinumab Biosimilar) group to receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16). At Week 28, subjects in the SB17 group were re-randomised (to maintain blindness) but continued to receive SB17 during the transition period (i.e., Week 28 and Week 40). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Main Period |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 15, 2021 | Dec 24, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
| SB17 (Proposed Ustekinumab Biosimilar) | Drug | Subjects randomised into SB17 group will receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40. Starting at Week 28, subjects transited from Stelara® to SB17 will receive SB17 via subcutaneous injection. |
|
| Ostrava |
| Czechia |
| SB Investigative Site | Pardubice | Czechia |
| SB Investigative Site | Prague | Czechia |
| SB investigative site | Tallinn | Estonia |
| SB Investigative Site | Tartu | Estonia |
| SB Investigative Site | Zalaegerszeg | Hungary |
| SB Investigative Site | Riga | Latvia |
| SB Investigative Site | Talsi | Latvia |
| SB Investigative Site | Kaunas | Lithuania |
| SB Investigative Site | Vilnius | Lithuania |
| SB Investigative Site | Elblag | Poland |
| SB Investigative Site | Kielce | Poland |
| SB Investigative Site | Krakow | Poland |
| SB Investigative Site | Lodz | Poland |
| SB Investigative Site | Lublin | Poland |
| SB Investigative Site | Rzeszów | Poland |
| SB Investigative Site | Siedlce | Poland |
| SB Investigative Site | Skierniewice | Poland |
| SB Investigative Site | Świdnik | Poland |
| SB Investigative Site | Warsaw | Poland |
| SB Investigative Site | Seongnam | South Korea |
| SB Investigative Site | Suwon | South Korea |
| SB Investigative Site | Dnipro | Ukraine |
| SB Investigative Site | Kharkiv | Ukraine |
| SB Investigative Site | Kherson | Ukraine |
| SB Investigative Site | Kyiv | Ukraine |
| SB Investigative Site | Lviv | Ukraine |
| SB Investigative Site | Odesa | Ukraine |
| SB Investigative Site | Uzhhorod | Ukraine |
| SB Investigative Site | Vinnytsia | Ukraine |
| SB Investigative Site | Zaporizhzhia | Ukraine |
| FG001 | Stelara (Ustekinumab) | Subjects were randomised into Stelara (Ustekinumab) group to receive Stelara (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16). At Week 28, subjects in the Stelara (Ustekinumab) group were re-randomised and either transitioned to SB17 or continued to receive Stelara during the transition period (i.e., Week 28 and Week 40). |
| FG002 | Stelara to SB17 | Subjects, who were randomised at Week 0 to receive Stelara (Ustekinumab) in the Main Period, were re-randomised at Week 28 to receive SB17 once every 12 weeks during the transition period (i.e., Week 28 and Week 40). |
| FG003 | Stelara to Stelara | Subjects, who were randomised at Week 0 to receive Stelara (Ustekinumab) in the Main Period, were re-randomised at Week 28 to receive Stelara (Ustekinumab) once every 12 weeks during the transition period (i.e., Week 28 and Week 40). |
| COMPLETED |
|
| NOT COMPLETED |
|
| Transition Period |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | SB17 (Proposed Ustekinumab Biosimilar) | Subjects were randomised into SB17 (Proposed Ustekinumab Biosimilar) group to receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16). At Week 28, subjects in the SB17 group were re-randomised (to maintain blindness) but continued to receive SB17 during the transition period (i.e., Week 28 and Week 40). |
| BG001 | Stelara (Ustekinumab) | Subjects were randomised into Stelara (Ustekinumab) group to receive Stelara (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16). At Week 28, subjects in the Stelara (Ustekinumab) group were re-randomised and either transitioned to SB17 or continued to receive Stelara during the transition period (i.e., Week 28 and Week 40). |
| 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
| |||||||||||||||||
| Total psoriasis BSA involvement | Mean | Standard Deviation | % |
| |||||||||||||||||
| Duration of psoriasis | Mean | Standard Deviation | years |
| |||||||||||||||||
| PASI at baseline | Mean | Standard Deviation | index |
| |||||||||||||||||
| PGA Score of ≥ 4 (Marked or Severe) at baseline | Count of Participants | Participants |
| ||||||||||||||||||
| Dermatology Life Quality Index (DLQI) at baseline | DLQI score ranges from 0 to 30 (a lower score means better quality of life). | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||||
| History of psoriatic arthritis | Count of Participants | Participants |
|
| 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 | Percent Change From Baseline in PASI at Week 12 | Psoriasis area severity index (PASI) measures the activity of psoriasis through erythema, induration and scaling and can range from 0 to 72. The degree of PASI improvement in terms of percent change from baseline at Week 12 is measured. | Posted | Least Squares Mean | Standard Error | Percent change | Baseline and Week 12 |
|
|
|
Overall Period (up to 52 weeks)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SB17 (Proposed Ustekinumab Biosimilar) | Subjects were randomised into SB17 (Proposed Ustekinumab Biosimilar) group to receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16). At Week 28, subjects in the SB17 group were re-randomised (to maintain blindness) but continued to receive SB17 during the transition period (i.e., Week 28 and Week 40). | 0 | 249 | 7 | 249 | 50 | 249 |
| EG001 | Stelara (Ustekinumab) | Subjects were randomised into Stelara (Ustekinumab) group to receive Stelara (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks until Week 28 (i.e., Week 0, Week 4, and Week 16). At Week 28, subjects in the Stelara (Ustekinumab) group were re-randomised and either transitioned to SB17 or continued to receive Stelara during the transition period (i.e., Week 28 and Week 40). | 0 | 254 | 6 | 254 | 62 | 254 |
| EG002 | Stelara to SB17 | Subjects, who were randomised at Week 0 to receive Stelara (Ustekinumab) in the Main Period, were re-randomised at Week 28 to receive SB17 once every 12 weeks during the transition period (i.e., Week 28 and Week 40). | 0 | 122 | 2 | 122 | 28 | 122 |
| EG003 | Stelara to Stelara | Subjects, who were randomised at Week 0 to receive Stelara (Ustekinumab) in the Main Period, were re-randomised at Week 28 to receive Stelara (Ustekinumab) once every 12 weeks during the transition period (i.e., Week 28 and Week 40). | 0 | 122 | 3 | 122 | 31 | 122 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | Systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| ||
| Salivary gland calculus | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Systematic Assessment |
| ||
| Fibula fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Joint dislocation | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Meniscus injury | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Tibia fracture | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Ischaemic stroke | Nervous system disorders | Systematic Assessment |
| ||
| Prerenal failure | Renal and urinary disorders | Systematic Assessment |
| ||
| Ovarian cyst torsion | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Pelvic adhesions | Reproductive system and breast disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| COVID-19 | Infections and infestations | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Samsung Bioepis Co., Ltd | +82-32-728-0371 | sbregistry@samsung.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2022 | Dec 24, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| 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 |
Not provided
Not provided
| >=65 years |
|
| Male |
|
| Mixed Ethnicity |
|
| Other |
|
| White |
|
| No |
|