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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-001045-39 | EudraCT Number |
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This study is a randomized, active-controlled, double-blind, phase 3 study to compare the efficacy and safety of CT-P43 to Stelara in patients with moderate to severe plaque psoriasis.
CT-P43, containing the active ingredient ustekinumab, is a human IgG1κ monoclonal antibody that is being developed as a biosimilar medicinal product to the reference product, Stelara. The purpose of this study is to demonstrate similar efficacy and safety of CT-P43 and Stelara in patients with moderate to severe plaque psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P43 | Experimental | All patients who were initially randomized to the CT-P43 group on Day 1 (Week 0) will continue their treatment with CT-P43 until Week 40. |
|
| Stelara | Active Comparator | Patients who were initially randomized to Stelara group on Day 1 (Week 0) will be randomized again in a ratio of 1:1 to either continue Stelara or undergo transition to CT-P43 prior to dosing at Week 16. Thereafter, patients will continue their treatment until Week 40. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P43 | Biological | 45mg or 90mg dose subcutaneous administration |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Percent Improvement From Baseline in PASI Score at Week 12 | The percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis). | From baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The PASI Scores at Week 12 | The Psoriasis Area and Severity Index (PASI) score at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis). | Week 12 |
| The Mean Percent Improvement From Baseline in PASI Score Through Week 52 |
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Inclusion Criteria:
- Patient has had diagnosis of plaque-type psoriasis for at least 24 weeks.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Centre | Tartu | Tartu Country, Estonia | 50106 | Estonia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37991693 | Derived | Papp KA, Lebwohl MG, Thaci D, Jaworski J, Kwiek B, Trefler J, Dudek A, Szepietowski JC, Reznichenko N, Narbutt J, Baran W, Kolinek J, Daniluk S, Bartnicka-Maslowska K, Reich A, Andrashko Y, Kim S, Bae Y, Jeon D, Jung J, Lee H, Pyo T, Ko W. Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III Study. BioDrugs. 2024 Jan;38(1):121-131. doi: 10.1007/s40259-023-00630-5. Epub 2023 Nov 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT-P43 | Treatment Period I: Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed >100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight. Treatment Period II: All patients who received CT-P43 during Treatment Period I and continued to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40). |
| FG001 | EU-Stelara | Treatment Period I: Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed >100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight. Treatment Period II: Patients who were initially randomly assigned to EU-Stelara at Day 1 (Week 0) were to continue to receive EU-Stelara in Treatment Period II (at Weeks 16, 28 and 40). |
| FG002 | Switched to CT-P43 | Treatment Period I: Not applicable Treatment Period II: Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period I (Weeks 0 to 16) |
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| Treatment Period II (Weeks 16 to 52) |
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| ID | Title | Description |
|---|---|---|
| BG000 | CT-P43 | Treatment Period I: Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed >100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight. |
| BG001 | EU-Stelara |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | The Mean Percent Improvement From Baseline in PASI Score at Week 12 | The percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis). | Modified ITT Set | Posted | Least Squares Mean | Standard Error | percentage of improvement in PASI score | From baseline to Week 12 |
|
Through 52 weeks
Treatment Period I: Week 0 to Week 16 pre-dose; Treatment Period II: Week 16 to Week 52 (End-of-study visit)
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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 | Treatment Period I: CT-P43 | Patients who were initially randomly assigned to CT-P43 45 mg (who weighed ≤100 kg) or 90 mg (who weighed >100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal inflammation | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
Due to the conflict in Ukraine, sponsor provided guideline for exceptional allowance regarding visit window and study assessments (only EOS visit was affected) in order to ensure patients' safety and the robustness and integrity of data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Planning | CELLTRION, Inc. | +82-32-850-4160 | YunJu.Bae@celltrion.com |
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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 | Jul 14, 2021 | May 2, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 22, 2022 | May 2, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Stelara |
| Biological |
45mg or 90mg dose subcutaneous administration |
|
The percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score through Week 52. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis).
| Through Week 52 |
| The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12 | The number of participants achieving at least 50%/75%/90%/100% improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis). | Week 12 |
| The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12 | The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the erythema, average thickness, and scaling of all psoriatic lesions at a given time point. The sum of the 3 scales will be divided by 3 to obtain a final sPGA score. | Week 12 |
| The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52 | This DLQI is a 10-item patient-reported outcome questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Total scores range from 0 to 30 (less to more impairment). | Through Week 52 |
|
| NOT COMPLETED |
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|
Treatment Period I: Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed >100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
Treatment Period I: Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed >100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight.
|
|
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| Secondary | The PASI Scores at Week 12 | The Psoriasis Area and Severity Index (PASI) score at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis). | Modified ITT Set (participants analysed at Week 12) | Posted | Mean | Standard Deviation | score on a scale | Week 12 |
|
|
|
| Secondary | The Mean Percent Improvement From Baseline in PASI Score Through Week 52 | The percent improvement from baseline in Psoriasis Area and Severity Index (PASI) score through Week 52. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis). | Modified ITT Set | Posted | Mean | Standard Deviation | percentage of improvement in PASI score | Through Week 52 |
|
|
|
| Secondary | The Number of Patients Achieving PASI 50, PASI 75, PASI 90, and PASI 100 Responses at Week 12 | The number of participants achieving at least 50%/75%/90%/100% improvement from baseline in Psoriasis Area and Severity Index (PASI) at Week 12. PASI score can range from 0 (no psoriasis) to 72 (severe psoriasis). | Modified ITT Set | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | The Number of Patients With sPGA Score of Clear (0) or Almost Clear (1) at Week 12 | The sPGA is a 5-point score ranging from 0 to 4, based on the physician's assessment of the erythema, average thickness, and scaling of all psoriatic lesions at a given time point. The sum of the 3 scales will be divided by 3 to obtain a final sPGA score. | Modified ITT Set | Posted | Count of Participants | Participants | Week 12 |
|
|
|
| Secondary | The Change From Baseline in Dermatology Life Quality Index (DLQI) Through Week 52 | This DLQI is a 10-item patient-reported outcome questionnaire that, in addition to evaluating overall QoL, can be used to assess 6 different aspects that may affect QoL: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships, and treatment. Total scores range from 0 to 30 (less to more impairment). | Modified ITT set | Posted | Mean | Standard Deviation | score on a scale | Through Week 52 |
|
|
|
| 0 |
| 256 |
| 4 |
| 256 |
| 14 |
| 256 |
| EG001 | Treatment Period I: EU-Stelara | Patients who were initially randomly assigned to EU-Stelara 45 mg (who weighed ≤100 kg) or 90 mg (who weighed >100 kg) administered subcutaneously in Treatment Period I (at Weeks 0 and 4) based on patient's baseline body weight. | 0 | 253 | 4 | 253 | 20 | 253 |
| EG002 | Treatment II: CT-P43 Maintenance | All patients who received CT-P43 during Treatment Period I and continued to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40). | 1 | 253 | 5 | 253 | 35 | 253 |
| EG003 | Treatment Period II: EU-Stelara Maintenance | Patients who were initially randomly assigned to EU-Stelara at Day 1 (Week 0) were to continue to receive EU-Stelara in Treatment Period II (at Weeks 16, 28 and 40). | 0 | 125 | 3 | 125 | 25 | 125 |
| EG004 | Treatment Period II: Switched to CT-P43 | Patients who received EU-Stelara during Treatment Period I and re-randomized to receive CT-P43 in Treatment Period II (at Weeks 16, 28 and 40). | 0 | 124 | 2 | 124 | 28 | 124 |
| COVID-19 pneumonia | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Subarachnoid haemorrhage | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 24.1 | Systematic Assessment |
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| Bipolar disorder | Psychiatric disorders | MedDRA 24.1 | Systematic Assessment |
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| Menstrual disorder | Reproductive system and breast disorders | MedDRA 24.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 24.1 | Systematic Assessment |
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| Pancreatitis acute | Gastrointestinal disorders | MedDRA 24.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Colon adenoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
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| Tubular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 24.1 | Systematic Assessment |
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| Guillain-Barre syndrome | Nervous system disorders | MedDRA 24.1 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 24.1 | Systematic Assessment |
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| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 24.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Latent tuberculosis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 24.1 | Systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 24.1 | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 24.1 | Systematic Assessment |
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| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| PASI 90 |
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| PASI 100 |
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