Clinical trial • Phase III • Dermatology
SECUKINUMAB for Plaque psoriasis
Phase III trial of SECUKINUMAB for Plaque psoriasis.
Overview
- Trial Therapeutic Area
- Dermatology
- Trial Disease
- Plaque psoriasis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 11-10-2024
- First CTIS Authorization Date
- 17-02-2025
Trial design
Randomised, eu-approved cosentyx 150 mg solution for injection in pre-filled syringe: 300 mg by 2 sc injections of 150 mg/ml via pfs every week for 5 doses, followed by every 4 weeks (cosentyx maintenance group). also an eu-approved cosentyx (switching group): 300 mg by 2 sc injections of 150 mg/ml via pfs every week for 5 doses, eu-approved cosentyx at week 8, followed by every 4 weeks for ct-p55 10 doses (switching to ct-p55 after week 8).-controlled Phase III trial across 12 sites in Poland.
- Randomised
- Yes
- Comparator
- EU-approved Cosentyx 150 mg solution for injection in pre-filled syringe: 300 mg by 2 SC injections of 150 mg/mL via PFS every week for 5 doses, followed by every 4 weeks (Cosentyx maintenance group). Also an EU-approved Cosentyx (switching group): 300 mg by 2 SC injections of 150 mg/mL via PFS every week for 5 doses, EU-approved Cosentyx at Week 8, followed by every 4 weeks for CT-P55 10 doses (switching to CT-P55 after Week 8).
- Target Sample Size
- 153
- Trial Duration For Participant
- 392
Eligibility
Recruits 153 No vulnerable population selected; participants are adults aged 18 to 75 years. Assent/consent handling not specified in the available CTIS JSON; participant information and consent forms are listed (Polish language versions) but no additional vulnerable-population consent/assent details are provided..
- Vulnerable Population
- No vulnerable population selected; participants are adults aged 18 to 75 years. Assent/consent handling not specified in the available CTIS JSON; participant information and consent forms are listed (Polish language versions) but no additional vulnerable-population consent/assent details are provided.
Inclusion criteria
- {"criterion_text":"- Patient is male or female aged 18 to 75 years old, both inclusive."}
- {"criterion_text":"- Patient has a body weight of <110 kg."}
- {"criterion_text":"- 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)."}
- {"criterion_text":"- 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
- {"criterion_text":"- Patient diagnosed with forms of psoriasis other than chronic plaque-type or medication-induced psoriasis."}
- {"criterion_text":"- Patient who currently has or has a history of human immunodeficiency virus, hepatitis B/C, tuberculosis, or certain other infections."}
- {"criterion_text":"- 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."}
- {"criterion_text":"- Patient who has received or plans to receive any of the prohibited medications or treatments."}
- {"criterion_text":"- Patient not willing to limit ultraviolet light exposure."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Percent change from baseline in PASI score at Week 8","definition_or_measurement_approach":"Percent change from baseline in Psoriasis Area and Severity Index (PASI) score at Week 8 (assessment of PASI score change from baseline to Week 8)."}
Recruitment
- Planned Sample Size
- 153
- Recruitment Window Months
- 17
- Consent Approach
- Written informed consent by participants (adults aged 18-75). No assent process is applicable (participants are adults). Subject information and informed consent forms are listed and available in Polish (documents: L1_Main-ICF_pl_public, L1_Biomarker-ICF_pl_public, L1_Pregnant-Partner-ICF_pl_public).
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 153
Poland
- Earliest CTIS Part Ii Submission Date
- 24-01-2025
- Latest Decision Or Authorization Date
- 09-02-2026
- Processing Time Days
- 381
- Number Of Sites
- 12
- Number Of Participants
- 153
Sites
- Site Name
- Specjalistyczny Gabinet Dermatologiczny Aplikacyjno Badawczy Marek Brzewski Paweł Brzewski s.c.
- Department Name
- Dermatology
- Principal Investigator Name
- Paweł Brzewski
- Principal Investigator Email
- brzewski@sgd-polska.com
- Contact Person Name
- Paweł Brzewski
- Contact Person Email
- brzewski@sgd-polska.com
- Site Name
- Zdrowie Osteo-Medic S.C. Lidia i Artur Racewicz, Agnieszka i Jerzy Supronik
- Department Name
- Dermatology
- Principal Investigator Name
- Małgorzata Janczyło-Jankowska
- Principal Investigator Email
- jjgosia@gmail.com
- Contact Person Name
- Małgorzata Janczyło-Jankowska
- Contact Person Email
- jjgosia@gmail.com
- Site Name
- Clinical Best Solutions Sp. z o.o. S.K.
- Department Name
- Dermatology
- Principal Investigator Name
- Mariusz Sikora
- Principal Investigator Email
- drmariuszsikora@gmail.com
- Contact Person Name
- Mariusz Sikora
- Contact Person Email
- drmariuszsikora@gmail.com
- Site Name
- Dermoklinika-Centrum Medyczne s.c. M. Kierstan J. Narbutt A. Lesiak
- Department Name
- Dermatology
- Principal Investigator Name
- Joanna Narbutt
- Principal Investigator Email
- joanna.narbutt@onet.pl
- Contact Person Name
- Joanna Narbutt
- Contact Person Email
- joanna.narbutt@onet.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
- Department Name
- Dermatology
- Principal Investigator Name
- Adam Reich
- Principal Investigator Email
- adamandrzejreich@gmail.com
- Contact Person Name
- Adam Reich
- Contact Person Email
- adamandrzejreich@gmail.com
- Site Name
- Centrum Badan Klinicznych Pi-House Sp. z o.o.
- Department Name
- Dermatology
- Principal Investigator Name
- Aleksandra Okuniewska
- Principal Investigator Email
- a.okuniewska@pihouse.pl
- Contact Person Name
- Aleksandra Okuniewska
- Contact Person Email
- a.okuniewska@pihouse.pl
- Site Name
- NZOZ Lecznica Mak Med s.c.
- Department Name
- Rheumatology
- Principal Investigator Name
- Marek Krogulec
- Principal Investigator Email
- marekkrogulec@wp.pl
- Contact Person Name
- Marek Krogulec
- Contact Person Email
- marekkrogulec@wp.pl
- Site Name
- Klinika Reuma Park Sp. z o.o. S.K.
- Department Name
- Rheumatology
- Principal Investigator Name
- Janusz Jaworski
- Principal Investigator Email
- januszjaworski@ymail.com
- Contact Person Name
- Janusz Jaworski
- Contact Person Email
- januszjaworski@ymail.com
- Site Name
- Dermmedica Sp. z o.o.
- Department Name
- Dermatology
- Principal Investigator Name
- Jolanta Weglowska
- Principal Investigator Email
- jolanta.weglowska@dermmedica.pl
- Contact Person Name
- Jolanta Weglowska
- Contact Person Email
- jolanta.weglowska@dermmedica.pl
- Site Name
- Wromedica I Bielicka A Strzalkowska s.c.
- Department Name
- Dermatology
- Principal Investigator Name
- Wojciech Baran
- Principal Investigator Email
- wojciech.baran@umw.edu.pl
- Contact Person Name
- Wojciech Baran
- Contact Person Email
- wojciech.baran@umw.edu.pl
- Site Name
- Royalderm Agnieszka Nawrocka
- Department Name
- Dermatology
- Principal Investigator Name
- Witold Owczarek
- Principal Investigator Email
- witold.owczarek@dermedicus.pl
- Contact Person Name
- Witold Owczarek
- Contact Person Email
- witold.owczarek@dermedicus.pl
- Site Name
- Clinicmed Daniluk Nowak Sp. k.
- Department Name
- Rheumatology
- Principal Investigator Name
- Stefan Daniluk
- Principal Investigator Email
- daniluk@clinicmed.pl
- Contact Person Name
- Stefan Daniluk
- Contact Person Email
- daniluk@clinicmed.pl
Sponsor
Primary sponsor
- Full Name
- Celltrion Inc.
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Korea, Republic of
Investigational products
- Investigational Product Name
- CT-P55
- Active Substance
- SECUKINUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- Subcutaneous injection
- Starting Dose
- 300 mg (two 150 mg SC injections) weekly for initial dosing (5 doses)
- Dose Levels
- 300 mg
- Frequency
- Weekly until Week 4 (5 weekly doses), then every 4 weeks from Week 8 to Week 48
- Maximum Dose
- maxDailyDoseAmount: 300 mg; maxTotalDoseAmount: 4800 mg
- Investigational Product Name
- Cosentyx 150 mg solution for injection in pre-filled syringe
- Active Substance
- SECUKINUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- Subcutaneous injection
- Authorisation Status
- Authorised (marketing authorisation EU/1/14/980/003)
- Starting Dose
- 300 mg (two 150 mg SC injections) weekly for initial dosing (5 doses)
- Dose Levels
- 300 mg
- Frequency
- Weekly until Week 4 (5 weekly doses), then every 4 weeks from Week 8 to Week 48
- Maximum Dose
- maxDailyDoseAmount: 300 mg; maxTotalDoseAmount: 4800 mg
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