Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
153
Countries
1
Sites
12
Plaque psoriasis
To demonstrate that CT-P55 is equivalent to EU-approved Cosentyx, in terms of efficacy as determined by the percent change from baseline in Psoriasis Area and Severity Index (PASI) score at Week 8
Key facts
- Sponsor
- Celltrion Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Trial duration
- 9 May 2025 → ongoing
- Decision date (initial)
- 2025-02-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- CELLTRION, Inc.
External identifiers
- EU CT number
- 2024-513348-27-00
- ClinicalTrials.gov
- NCT06630559
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To demonstrate that CT-P55 is equivalent to EU-approved Cosentyx, in terms of efficacy as determined by the percent change from baseline in Psoriasis Area and Severity Index (PASI) score at Week 8
Secondary objectives 1
- To evaluate additional efficacy, pharmacokinetics (PK) and overall safety including immunogenicity up to Week 56
Conditions and MedDRA coding
Plaque psoriasis
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10071117 | Plaque psoriasis | 10040785 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment period The patient will receive either CT-P55 or EU-approved Cosentyx, as per the first and second randomization, by SC injection every week until Week 4 and then every 4 weeks from Week 8 to Week 48.
|
Randomised Controlled | Double | [{"id":164674,"code":4,"name":"Analyst"},{"id":164671,"code":3,"name":"Monitor"},{"id":164675,"code":2,"name":"Investigator"},{"id":164673,"code":5,"name":"Carer"},{"id":164672,"code":1,"name":"Subject"}] | CT-P55: 300 mg by 2 SC injections of 150 mg/mL via PFS every week for CT-P55 5 doses, followed by every 4 weeks for CT-P55 11 doses EU-approved Cosentyx (Cosentyx maintenance group): 300 mg by 2 SC injections of 150 mg/mL via PFS every week for EU-approved Cosentyx 5 doses, followed by every 4 weeks for EU-approved Cosentyx 11 doses EU-approved Cosentyx (switching group): 300 mg by 2 SC injections of 150 mg/mL via PFS every week for EU-approved Cosentyx 5 doses, EU-approved Cosentyx at Week 8, followed by every 4 weeks for CT-P55 10 doses |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Patient is male or female aged 18 to 75 years old, both inclusive.
- Patient has a body weight of <110 kg.
- Patient has had a diagnosis of chronic plaque psoriasis for at least 24 weeks prior to the first administration of the study drug (Day 1).
- Patient has stable moderate to severe psoriasis with or without psoriatic arthritis at both Screening and at the time of the first administration of the study drug (Day 1) as defined by; a) PASI score of 12 or greater and b) Investigator’s Global Assessment (IGA) score of 3 or greater (based on a scale of 0 to 4) and c) Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater.
Exclusion criteria 5
- Patient diagnosed with forms of psoriasis other than chronic plaque-type or medication-induced psoriasis.
- Patient who currently has or has a history of human immunodeficiency virus, hepatitis B/C, tuberculosis, or certain other infections.
- Patient who has the following medical conditions; uncontrolled diabetes mellitus, uncontrolled hypertension or cardiac disease, ongoing inflammatory disease, current or history of inflammatory bowel disease, ongoing eczematous eruptions, history of lymphoproliferative disease or malignancy within the 5 years, or clinically significant demyelinating disorders.
- Patient who has received or plans to receive any of the prohibited medications or treatments.
- Patient not willing to limit ultraviolet light exposure.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Percent change from baseline in PASI score at Week 8
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11550481 · Product
- Active substance
- Secukinumab
- Other product name
- Secukinumab
- Pharmaceutical form
- INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 4800 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELLTRION INC.
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
Cosentyx 150 mg solution for injection in pre-filled syringe
PRD2398836 · Product
- Active substance
- Secukinumab
- Substance synonyms
- Recombinant human monoclonal antibody to human interleukin (IL)-17A of the IgG1/k class, AIN457
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 4800 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- L04AC10 — -
- Marketing authorisation
- EU/1/14/980/003
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celltrion Inc.
- Sponsor organisation
- Celltrion Inc.
- Address
- 13-1 Songdo-Dong
- City
- Incheon
- Postcode
- 22014
- Country
- Korea, Republic of
Scientific contact point
- Organisation
- Celltrion Inc.
- Contact name
- Clinical Planning
Public contact point
- Organisation
- Celltrion Inc.
- Contact name
- Clinical Operation
Locations
1 EU/EEA country · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruitment ended | 153 | 12 |
| Rest of world | — | 0 | — |
Investigational sites
Royalderm Agnieszka Nawrocka
Dermatology, ul. Krzysztofa Kieślowskiego 3B/3, 02-962, Warszawa
Clinical Best Solutions Sp. z o.o. S.K.
Dermatology, Ul. Ludwika Idzikowskiego 16, 00-710, Warsaw
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Dermatology, Ul. Na Zaspe 3, 80-546, Gdansk
Dermmedica Sp. z o.o.
Dermatology, Ul. Krzysztofa Kolumba 6, 51-503, Wroclaw
Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy Marek Brzewski Paweł Brzewski s.c.
Dermatology, ul. Zbozowa 2/25, 30-002, Krakow
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Dermatology, Ul. Fryderyka Szopena 2, 35-055, Rzeszow
Klinika Reuma Park Sp. z o.o. S.K.
Rheumatology, Aleja Wilanowska 333, 02-665, Warsaw
Wromedica I Bielicka A Strzalkowska s.c.
Dermatology, Ul. Adama Mickiewicza 91, 51-685, Wroclaw
Zdrowie Osteo-Medic S.C. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
Dermatology, ul Wiejska 81, 15-351, Białystok
Dermoklinika-Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
Dermatology, Al. Tadeusza Kościuszki 93, 90-436, Łódź
NZOZ Lecznica Mak Med s.c.
Rheumatology, Ul. Wisniowa 22, 05-830, Nadarzyn
Clinicmed Daniluk Nowak Sp. k.
Rheumatology, Ul. Stoleczna 7/200, 15-879, Bialystok
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Poland | 2025-05-09 | 2025-05-09 | 2025-09-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-513348-27_Public | 5.0 |
| Protocol (for publication) | D3_11 point NRS_pl | 1.1 |
| Protocol (for publication) | D3_DLQI_pl | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_pl | 1 |
| Subject information and informed consent form (for publication) | L1_Biomarker-ICF_pl_public | 1.4 |
| Subject information and informed consent form (for publication) | L1_Main-ICF_pl_public | 4.2 |
| Subject information and informed consent form (for publication) | L1_Pregnant-Partner-ICF_pl_public | v1.4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cosentyx | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_en_2024-513348-27_Public | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_pl_2024-513348-27_Public | 5.0 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | Poland | Acceptable 2025-02-10
|
2025-02-17 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-01 | Poland | Acceptable 2025-02-10
|
2025-07-01 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-10-27 | Poland | Acceptable 2026-02-06
|
2026-02-09 |