Clinical trial • Phase III|Phase IV • Immunology|Dermatology
DEUCRAVACITINIB for Moderate-to-severe plaque psoriasis
Phase III|Phase IV trial of DEUCRAVACITINIB for Moderate-to-severe plaque psoriasis.
Overview
- Trial Therapeutic Area
- Immunology|Dermatology
- Trial Disease
- Moderate-to-severe plaque psoriasis
- Trial Stage
- Phase III|Phase IV
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 16-09-2025
- First CTIS Authorization Date
- 19-01-2026
Trial design
Randomised, open-label, ustekinumab: comparator arm using ustekinumab (subcutaneous injection). product entries include dosing strengths represented as 45 mg and 90 mg (listed as maxdailydoseamount values); schedule not specified in the json.-controlled Phase III|Phase IV trial in Spain, Poland, Germany and others.
- Randomised
- Yes
- Open Label
- Yes
- Comparator
- Ustekinumab: comparator arm using ustekinumab (subcutaneous injection). Product entries include dosing strengths represented as 45 mg and 90 mg (listed as maxDailyDoseAmount values); schedule not specified in the JSON.
- Target Sample Size
- 1752
- Trial Duration For Participant
- 1825
Eligibility
Recruits 1752 No vulnerable population selected; participants are adults (age criteria: adults aged 40 years or older). No special assent procedures mentioned..
- Vulnerable Population
- No vulnerable population selected; participants are adults (age criteria: adults aged 40 years or older). No special assent procedures mentioned.
Inclusion criteria
- {"criterion_text":"- Adult participants aged 40 years or older (inclusive)\n- Participants with moderate-to-severe plaque psoriasis as defined by a PASI ≥ 12, BSA ≥ 10% and sPGA score ≥ 3 at the time of the Screening Visit and Day 1 visits\n- Participants who are candidates for phototherapy or systemic treatment of psoriasis\n- Eligible participants should have at least 1 of the following cardiovascular risk factors: Current cigarette smoker, Diagnosis of hypertension or use of blood pressure-lowering medications, Diagnosis of dyslipidemia, Diabetes mellitus type 1 or 2, History of 1 or more of the following CVD events: coronary revascularization procedures including PCI or CABG, MI, cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack, Obesity defined by a body mass index ≥ 30 kg/m2, Family history of premature coronary heart disease"}
Exclusion criteria
- {"criterion_text":"- Recent history of 1 or more of the following cardiovascular events: MI, stroke, history of coronary revascularization, or VTE within 90 days prior to Day 1\n- Evidence of active cancer or a history of cancer or lymphoproliferative disease within the previous 5 years"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Composite cardiovascular endpoint defined as: adjudicated 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) plus coronary revascularization","definition_or_measurement_approach":"Adjudicated composite cardiovascular endpoint defined as adjudicated 3-point MACE (non-fatal MI, non-fatal stroke, and cardiovascular death) plus coronary revascularization (event adjudication implied by wording)."}
Secondary endpoints
- {"endpoint_text":"- Adjudicated events of: Non-fatal MI, non-fatal stroke, cardiovascular death, coronary revascularization, 3-point MACE (non-fatal MI, nonfatal stroke, and cardiovascular death), PE, DVT, the composite of all VTE events of PE, DVT and retinal vein occlusion, arterial thromboembolic events (including retinal artery occlusion), HF requiring hospitalization or urgent care visit, malignancy excluding NMSC, NMSC, and opportunistic infections including TB and complicated herpes zoster","definition_or_measurement_approach":"Adjudicated clinical events (list provided in endpoint text)."}
- {"endpoint_text":"- SAEs, all-cause mortality, and AEs leading to permanent treatment discontinuation","definition_or_measurement_approach":"Standard safety reporting: serious adverse events, all-cause mortality, and AEs causing permanent discontinuation as recorded in trial safety data."}
- {"endpoint_text":"- Laboratory tests: complete metabolic panel, including liver function test and fasting lipid panel at baseline and every 26 weeks thereafter","definition_or_measurement_approach":"Laboratory measurements performed at baseline and every 26 weeks thereafter (complete metabolic panel including liver function tests and fasting lipid panel)."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 1752
- Recruitment Window Months
- 61
- Consent Approach
- Informed consent is obtained from adult participants. Country-specific subject information sheets and informed consent forms (SIS and ICF) are provided; documents are available in multiple languages as shown in file listings (examples include English, French, German, Polish, Spanish, Czech, Italian, Bulgarian, Dutch). There are also specific ICFs/materials for pregnant participants and pregnant partners in several countries.
Methods
- Country-specific recruitment arrangements documents (K1_Recruitment arrangements) — multiple country-specific K1 documents are present in the record (e.g. DE, PL, BE, FR, CZ, IT, SE, etc.)
- Posters (K2_Recruitment Material_Poster) — recruitment posters available in country-specific versions (filenames indicate DE, PL, ES, FR etc.)
- Brochures / Patient Brochure (K2_Recruitment Material_Brochure / K2_Recruitment material Brochure) — patient information brochures available in country-specific versions
- Study Fact Sheet (K2_Recruitment Material_Study Fact Sheet) — study fact sheet materials for potential participants
- Patient Database Letter (K2_Patient Database Letter_PL) — patient database / letter recruitment approach referenced in documents
- Patient Card and other subject information materials (L2_Other subject information material_Patient Card) listed for some countries
Geography
- Total Number Of Sites
- 128
- Total Number Of Participants
- 1289
Spain
- Earliest CTIS Part Ii Submission Date
- 16-01-2026
- Latest Decision Or Authorization Date
- 26-01-2026
- Processing Time Days
- 10
- Number Of Sites
- 10
- Number Of Participants
- 93
Sites
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Dermatology
- Principal Investigator Name
- Josep Riera Monroig
- Principal Investigator Email
- jriera@clinic.cat
- Contact Person Name
- Josep Riera Monroig
- Contact Person Email
- jriera@clinic.cat
Poland
- Earliest CTIS Part Ii Submission Date
- 09-01-2026
- Latest Decision Or Authorization Date
- 26-01-2026
- Processing Time Days
- 17
- Number Of Sites
- 30
- Number Of Participants
- 458
Sites
- Site Name
- Provita Sp. z o.o.
- Principal Investigator Name
- Anita Lewartowska-Białek
- Principal Investigator Email
- badania-kliniczne@angelius.pl
- Contact Person Name
- Anita Lewartowska-Białek
- Contact Person Email
- badania-kliniczne@angelius.pl
Germany
- Earliest CTIS Part Ii Submission Date
- 08-12-2025
- Latest Decision Or Authorization Date
- 20-01-2026
- Processing Time Days
- 43
- Number Of Sites
- 29
- Number Of Participants
- 227
Sites
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Zentrum für entzündliche Hauterkrankungen
- Principal Investigator Name
- Sascha Gerdes
- Principal Investigator Email
- sgerdes@dermatology.uni-kiel.de
- Contact Person Name
- Sascha Gerdes
- Contact Person Email
- sgerdes@dermatology.uni-kiel.de
Romania
- Earliest CTIS Part Ii Submission Date
- 11-12-2025
- Latest Decision Or Authorization Date
- 26-01-2026
- Processing Time Days
- 46
- Number Of Sites
- 11
- Number Of Participants
- 81
Sites
- Site Name
- Spitalul Clinic Cf Nr.2 Bucuresti
- Department Name
- Dermatology
- Principal Investigator Name
- Maria-Magdalena Constantin
- Principal Investigator Email
- ambulatoriu@spcf2.ro
- Contact Person Name
- Maria-Magdalena Constantin
- Contact Person Email
- ambulatoriu@spcf2.ro
Denmark
- Earliest CTIS Part Ii Submission Date
- 16-01-2026
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 17
- Number Of Sites
- 5
- Number Of Participants
- 23
Sites
- Site Name
- Region Hovedstaden
- Department Name
- Department of Dermatology, Bispebjerg Hospital
- Principal Investigator Name
- Simon Francis Thomsen
- Principal Investigator Email
- Simon.francis.thomsen.02@regionh.dk
- Contact Person Name
- Simon Francis Thomsen
- Contact Person Email
- Simon.francis.thomsen.02@regionh.dk
Belgium
- Earliest CTIS Part Ii Submission Date
- 09-12-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 55
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Dermatology
- Principal Investigator Name
- Pierre-Dominique Ghislain
- Principal Investigator Email
- pierre-dominique.ghislain@uclouvain.be
- Contact Person Name
- Pierre-Dominique Ghislain
- Contact Person Email
- pierre-dominique.ghislain@uclouvain.be
France
- Earliest CTIS Part Ii Submission Date
- 21-10-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 104
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Centre Hospitalier Universitaire De La Reunion
- Department Name
- Dermatologie
- Principal Investigator Name
- Antoine BERTOLOTTI
- Principal Investigator Email
- antoine.bertolotti@chu-reunion.fr
- Contact Person Name
- Antoine BERTOLOTTI
- Contact Person Email
- antoine.bertolotti@chu-reunion.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 03-10-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 122
- Number Of Sites
- 8
- Number Of Participants
- 42
Sites
- Site Name
- Humanitas Mirasole S.p.A.
- Department Name
- Unit Dermatology
- Principal Investigator Name
- Antonio Costanzo
- Principal Investigator Email
- antonio.costanzo@hunimed.eu
- Contact Person Name
- Antonio Costanzo
- Contact Person Email
- antonio.costanzo@hunimed.eu
Czechia
- Earliest CTIS Part Ii Submission Date
- 13-12-2025
- Latest Decision Or Authorization Date
- 16-02-2026
- Processing Time Days
- 65
- Number Of Sites
- 13
- Number Of Participants
- 165
Sites
- Site Name
- Fakultni Nemocnice Kralovske Vinohrady
- Department Name
- Dermatovenerologicka klinika
- Principal Investigator Name
- Spyridon Gkalpakiotis
- Principal Investigator Email
- Spyridon.gkalpakiotis@fnkv.cz
- Contact Person Name
- Spyridon Gkalpakiotis
- Contact Person Email
- Spyridon.gkalpakiotis@fnkv.cz
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 13-12-2025
- Latest Decision Or Authorization Date
- 22-01-2026
- Processing Time Days
- 40
- Number Of Sites
- 4
- Number Of Participants
- 71
Sites
- Site Name
- Uniteversity Muliprofile Hospital For Active Treatment Tsaritsa Yoanna-Isul EAD
- Department Name
- clinic – medical oncology, level III
- Principal Investigator Name
- Petranka Troyanova
- Principal Investigator Email
- xxxx@xxxx.com
- Contact Person Name
- Petranka Troyanova
- Contact Person Email
- xxxx@xxxx.com
Sweden
- Earliest CTIS Part Ii Submission Date
- 12-12-2025
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 52
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- ProbarE i Lund AB
- Department Name
- ProbarE i Lund
- Principal Investigator Name
- Anders Luts
- Principal Investigator Email
- anders.luts@probare.se
- Contact Person Name
- Anders Luts
- Contact Person Email
- anders.luts@probare.se
Hungary
- Earliest CTIS Part Ii Submission Date
- 16-01-2026
- Latest Decision Or Authorization Date
- 23-01-2026
- Processing Time Days
- 7
- Number Of Sites
- 9
- Number Of Participants
- 89
Sites
- Site Name
- Medmare Bt.
- Principal Investigator Name
- Levente Pal Kovago
- Principal Investigator Email
- drkovago@gmail.com
- Contact Person Name
- Levente Pal Kovago
- Contact Person Email
- drkovago@gmail.com
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- WCG Clinical Inc.
- Responsibilities
- Investigator trainings for clinical sites
- Name
- Iqvia Inc.
- Responsibilities
- Investigator Site Payments
- Name
- Bioclinica Inc.
- Responsibilities
- Adjudication services for malignancy, cardiovascular and infection events and Data Review
Third parties
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance: Medical review & Cases Data Entry","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Provides electronic payments, travel arrangements, electronic study-related communications to patients","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Investigator trainings for clinical sites","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Investigator Site Payments","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"Core Technology Services","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Providing adjudication services for malignancy, cardiovascular and infection events and Data Review","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long term sample storage for safety samples and biomarker residuals","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- deucravacitinib
- Active Substance
- DEUCRAVACITINIB
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Authorised product referenced (prodAuthStatus: 1)
- Maximum Dose
- Max daily dose listed as 6 mg
- Investigational Product Name
- USTEKINUMAB
- Active Substance
- USTEKINUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Authorisation Status
- Authorised product referenced (prodAuthStatus: 2)
- Starting Dose
- Not specified (product entries list 45 mg and 90 mg strengths)
- Dose Levels
- 45 mg; 90 mg (as listed in product entries)
- Maximum Dose
- Max daily dose entries listed as 45 mg and 90 mg in product records
Related trials
Other published trials that may interest you.