Plaque PsoriasisPhase 3NCT06630559
A Study to Compare Efficacy and Safety of CT-P55 and Cosentyx in Patients With Moderate to Severe Psoriasis
A Phase 3 study testing CT-P55 and EU-approved Cosentyx in people with Plaque Psoriasis, run by Celltrion at 1 site in Poland.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- CT-P55 and EU-approved Cosentyx
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 sitePoland
- Study dates
- 26 May 2025to Oct 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has had a diagnosis of chronic plaque psoriasis for at least 24 weeks.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P55 With Cosentyx in Patients With Moderate to Severe Plaque Psoriasis
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
Read the 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.
- Conditions
- Plaque Psoriasis
- Being tested
- CT-P55, EU-approved Cosentyx
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-P55Biological
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).
EU-approved CosentyxBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| CT-P55 | Experimental | Not described Receives: Biological: CT-P55 |
| EU-approved Cosentyx | Active comparator | Not described Receives: Biological: CT-P55; Biological: EU-approved Cosentyx |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week8
Secondary outcomes (5)
Actual PASI scores
Minimum 0 to Maximum 72 Higher scores mean a worse outcome
Measured: 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.
Measured: 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)
Measured: Up to 56 Weeks
Proportion of patients with Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1)
Measured: 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
Measured: Up to 56 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start26 May 2025
- Primary completion18 Feb 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marek Krogulec, Principal investigator, Rheumatology Clinic NZOZ Lecznica MAK-MED s.c.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06630559
- Sponsor's protocol ID
- CT-P55 3.1
- Other IDs
- 2024-513348-27
- Status last verified
- Feb 2026
- First submitted
- 7 Oct 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Active-Controlled, Double-Blind, Phase 3 Study to Compare Efficacy and Safety of CT-P55 With Cosentyx in Patients With Moderate to Severe Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT06630559
- Acronym / sponsor ID
- CT-P55 3.1
- Conditions
- Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 153 participants (actual)
- Lead sponsor
- CelltrionIndustry (pharma, biotech, devices)
- Study start
- 26 May 2025 (actual)
- Primary completion
- 18 Feb 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-P55 | Experimental | Biological: CT-P55 |
| EU-approved Cosentyx | Active comparator | Biological: CT-P55, Biological: EU-approved Cosentyx |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient has had a diagnosis of chronic plaque psoriasis for at least 24 weeks.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-P55CT-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). | Biological | CT-P55, EU-approved Cosentyx |
| EU-approved CosentyxEuropean 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). | Biological | EU-approved Cosentyx |
Primary outcome
Percent change from baseline in Psoriasis Area and Severity Index (PASI) score
Time frame: 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.
5 secondary outcomes
Actual PASI scores
Time frame: Up to 56 Weeks
Percent change from baseline in PASI score
Time frame: 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)
Time frame: Up to 56 Weeks
Proportion of patients with Investigator's Global Assessment (IGA) score of clear (0) or almost clear (1)
Time frame: Up to 56 Weeks
Change from baseline in Dermatology Life Quality Index (DLQI)
Time frame: Up to 56 Weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marek Krogulec principal investigator
Rheumatology Clinic NZOZ Lecznica MAK-MED s.c.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CT-P55 and EU-approved Cosentyx in people with Plaque Psoriasis, run by Celltrion at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change from baseline in Psoriasis Area and Severity Index (PASI) score (time frame: Week8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.