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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-513348-27 | EudraCT Number |
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The goal of this Phase 3 clinical trial is to compare efficacy and safety of CT-P55 with Cosentyx in patients with moderate to severe plaque psoriasis
CT-P55 is a recombinant humanized monoclonal antibody containing the active ingredient secukinumab. CT-P55 is a drug product being developed by CELLTRION, Inc. and being compared to the EU-approved Cosentyx®. In this study, Efficacy and Safety of CT-P55 will be evaluated in patients with Moderate to Severe Chronic Plaque Psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT-P55 | Experimental |
| |
| EU-approved Cosentyx | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT-P55 | Biological | CT-P55, 300 mg by 2 subcutaneous (SC) injections of 150 mg/mL via Pre-Filled Syringe (PFS) every week for 5 doses (up to Week 4 after starting dose at Day 1), followed by every 4 weeks (Q4W) for 11doses (up to Week 48). |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in Psoriasis Area and Severity Index (PASI) score | A higher percent change indicates a better outcome. While the maximum value is 100%, the minimum value is not fixed and may be negative in cases of worsening symptoms. | Week8 |
| Measure | Description | Time Frame |
|---|---|---|
| Actual PASI scores | Minimum 0 to Maximum 72 Higher scores mean a worse outcome | Up to 56 Weeks |
| Percent change from baseline in PASI score | A higher percent change indicates a better outcome. While the maximum value is 100%, the minimum value is not fixed and may be negative in cases of worsening symptoms. |
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Inclusion Criteria:
- Patient has had a diagnosis of chronic plaque psoriasis for at least 24 weeks.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marek Krogulec | Rheumatology Clinic NZOZ Lecznica MAK-MED s.c. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rheumatology Clinic NZOZ Lecznica MAK-MED s.c. | Nadarzyn | Poland |
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| EU-approved Cosentyx | Biological | European Union (EU)-approved Cosentyx, 300 mg by 2 SC injections of 150 mg/mL via PFS every week for 5 doses (up to Week 4 after starting dose at Day 1), followed by Q4W for 11 doses (up to Week 48). |
|
| Up to 56 Weeks |
| Proportion of patients who achieve at least 50/75/90/100% improvement from baseline in PASI (PASI 50/75/90/100) | Up to 56 Weeks |
| Proportion of patients with Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1) | Up to 56 Weeks |
| Change from baseline in Dermatology Life Quality Index (DLQI) | Minimum -30 to Maximum of 30 Higher scores indicate a worse outcome | Up to 56 Weeks |