Plaque Psoriasis
Conditions
Brief summary
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
Detailed description
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.
Interventions
BIOLOGICALCT-P55
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).
BIOLOGICALEU-approved Cosentyx
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).
Sponsors
Celltrion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\- Patient has had a diagnosis of chronic plaque psoriasis for at least 24 weeks.
Exclusion criteria
* Patient diagnosed with forms of psoriasis other than chronic plaque-type or medication-induced psoriasis. * Patient who has previously received Secukinumab or any other biologic drug directly targeting Interleukin-17 or the IL-17 receptor. * Patient who has allergies to any of the excipients of study drug or materials of device or any other murine and human proteins, or patient with a hypersensitivity to immunoglobulin products.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change from baseline in Psoriasis Area and Severity Index (PASI) score | Week8 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Actual PASI scores | Up to 56 Weeks | Minimum 0 to Maximum 72 Higher scores mean a worse outcome |
| Percent change from baseline in PASI score | Up to 56 Weeks | 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. |
| 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) | Up to 56 Weeks | Minimum -30 to Maximum of 30 Higher scores indicate a worse outcome |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORMarek Krogulec
Rheumatology Clinic NZOZ Lecznica MAK-MED s.c.
Outcome results
None listed