Clinical trial • Phase III • Immunology

DEUCRAVACITINIB for Moderate to severe plaque psoriasis

Phase III trial of DEUCRAVACITINIB for Moderate to severe plaque psoriasis.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Moderate to severe plaque psoriasis
Trial Stage
Phase III
Drug Modality
Small molecule
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
12-06-2025
First CTIS Authorization Date
08-10-2025

Trial design

Randomised, placebo to match deucravacitinib 6mg tablets in bottle, oral use; placebo to match deucravacitinib 2mg minitablets in sachet, oral use (placebo comparator arms).-controlled Phase III trial in Germany, Romania, Italy and others.

Randomised
Yes
Comparator
Placebo to match deucravacitinib 6mg tablets in bottle, oral use; Placebo to match deucravacitinib 2mg minitablets in sachet, oral use (placebo comparator arms).
Target Sample Size
221

Eligibility

Recruits 221 paediatric patients.

Pregnancy Exclusion
Females who are pregnant or breastfeeding
Vulnerable Population
Trial includes adolescent participants (12 to <18 years). Parental/legal guardian consent is required for minors and age-appropriate assent is obtained. Subject information, parental information/consent forms and assent forms are available (e.g. L1 SIS and ICF Assent 12-15y, Assent 16-17y, Parent ICF, Parent/Caregiver brochures) in multiple country/language versions.

Inclusion criteria

  • {"criterion_text":"- Subjects 12 to less than 18 years of age"}
  • {"criterion_text":"- Subjects with moderate to severe stable plaque psoriasis for at least 6 months"}
  • {"criterion_text":"- Subjects that are candidates for systemic (whole body) therapy or phototherapy"}

Exclusion criteria

  • {"criterion_text":"- Females who are pregnant or breastfeeding"}
  • {"criterion_text":"- Received live vaccines or BCG within 60 days prior to Day 1, or plans to receive a live vaccine during the study, or within 60 days after completing study intervention"}
  • {"criterion_text":"- Prior exposure to deucravacitinib"}
  • {"criterion_text":"- Received medication that is specifically prohibited"}
  • {"criterion_text":"- Subjects that has a laboratory finding that is exclusionary"}
  • {"criterion_text":"- Any major illness/condition or evidence of an unstable clinical condition"}
  • {"criterion_text":"- Subjects weighing < 30.0 kg at screening"}
  • {"criterion_text":"- Subjects who have non-plaque psoriasis"}
  • {"criterion_text":"- Subjects who have a psoriasis flare or rebound within 4 weeks prior to Screening"}
  • {"criterion_text":"- History or evidence of outpatient active infection and/or febrile illness within 7 days prior to Day 1"}
  • {"criterion_text":"- History of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1"}
  • {"criterion_text":"- Subjects with any untreated bacterial infection within 60 days prior to Day 1"}
  • {"criterion_text":"- Subjects with any ongoing evidence of chronic bacterial infection (e.g., chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis)"}
  • {"criterion_text":"- Herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Efficacy: Participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16.","definition_or_measurement_approach":"PASI score improvement assessed at Week 16; participants achieving ≥75% improvement from baseline (PASI 75)."}
  • {"endpoint_text":"- Efficacy: Participants achieving a sPGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16.","definition_or_measurement_approach":"sPGA score assessed at Week 16; response defined as sPGA = 0 or 1 plus ≥2-point reduction from baseline."}
  • {"endpoint_text":"- Safety (LTE): AEs and SAEs through study completion.","definition_or_measurement_approach":"Collection and reporting of adverse events (AEs) and serious adverse events (SAEs) through study completion (long-term extension)."}
  • {"endpoint_text":"- Safety (LTE): Monitoring of growth, including body weight and height and sexual maturation, through study completion.","definition_or_measurement_approach":"Periodic monitoring of growth parameters (body weight, height) and sexual maturation assessments through study completion (long-term extension)."}

Secondary endpoints

  • {"endpoint_text":"- Efficacy: Participants achieving at least 90% improvement in PASI (PASI 90) Week 16.","definition_or_measurement_approach":"PASI score improvement assessed at Week 16; participants achieving ≥90% improvement from baseline (PASI 90)."}
  • {"endpoint_text":"- Efficacy: Change from baseline in PASI at Week 16.","definition_or_measurement_approach":"Absolute or mean change in PASI score from baseline to Week 16."}
  • {"endpoint_text":"- Efficacy: Change from baseline in BSA involvement at Week 16.","definition_or_measurement_approach":"Change in Body Surface Area (BSA) affected by psoriasis from baseline to Week 16."}
  • {"endpoint_text":"- Safety: Treatment emergent AEs and SAEs, laboratory parameters, physical examination, and vital signs through study completion.","definition_or_measurement_approach":"Monitoring and reporting of treatment-emergent AEs/SAEs, lab results, physical exams and vital signs through study completion."}
  • {"endpoint_text":"- Safety: Participants with protective titers of antibodies to measles, tetanus, and pertussis at Week 16.","definition_or_measurement_approach":"Measurement of antibody titers (measles, tetanus, pertussis) at Week 16 and reporting of participants with protective titers."}
  • {"endpoint_text":"- Safety: Monitoring of growth including body weight and height, and sexual maturation through study completion.","definition_or_measurement_approach":"Periodic assessments of body weight, height, and sexual maturation through study completion."}
  • {"endpoint_text":"- Efficacy (LTE): Participants achieving 75% improvement in PASI (PASI 75) over time through study completion.","definition_or_measurement_approach":"Longitudinal assessment of PASI 75 achievement over time through study completion."}
  • {"endpoint_text":"- Efficacy (LTE): Participants achieving an sPGA score of 0 (clear) or 1(almost clear) with at least a 2-point reduction from baseline over time through study completion.","definition_or_measurement_approach":"Longitudinal assessment of sPGA 0/1 with ≥2-point reduction from baseline through study completion."}

Recruitment

Planned Sample Size
221
Recruitment Window Months
108
Consent Approach
Parental/legal guardian informed consent required for minors with age-appropriate assent obtained from adolescent participants. Multiple age-specific information sheets, consent and assent forms are provided (e.g. Assent 12-15y, Assent 16-17y, Parent ICF, Pregnant participant/partner forms) in multiple country/language versions as supplied in the documentation.

Methods

  • Use of country-specific recruitment arrangements (K1 recruitment arrangements documents available for DE, BE, PL, IT, HU, ES, RO).
  • Provision of recruitment materials including adolescent brochures, parent/caregiver brochures, posters, PI-to-Patient letters and Study Visit Guides (K2 recruitment materials; Adolescent Brochure; Parent/Caregiver Brochure; Posters).
  • Site-based recruitment via participating hospitals/clinics/universities (site listings and site contacts provided per country).

Geography

Total Number Of Sites
31
Total Number Of Participants
145

Germany

Earliest CTIS Part Ii Submission Date
04-09-2025
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
224
Number Of Sites
5
Number Of Participants
17

Sites

Site Name
BAG Dres. med. Quist PartG
Department Name
Dermatologie Quist - BAG Dres. Quist PartG
Contact Person Name
Sven Quist
Contact Person Email
studie@dermatologie-quist.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Psoriasis Forschungs- und BehandlungsCentrum
Contact Person Name
Sonja Christine Molin
Site Name
Universitaetsklinikum Erlangen AöR
Department Name
Hautklinik-Studienambulanz
Contact Person Name
Lukas Sollfrank
Contact Person Email
lukas.sollfrank@uk-erlangen.de
Site Name
Universitaet Muenster
Department Name
Klinik für Hautkrankheiten
Contact Person Name
Nina Magnolo
Contact Person Email
nina.magnolo@ukmuenster.de
Site Name
Technische Universitaet Dresden
Department Name
Klinik und Poliklinik für Dermatologie
Contact Person Name
Susanne Abraham

Romania

Earliest CTIS Part Ii Submission Date
24-09-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
208
Number Of Sites
4
Number Of Participants
18

Sites

Site Name
Lotus Med S.R.L.
Department Name
Dermato Venereology
Contact Person Name
Adelina Maria Sendrea
Contact Person Email
contact@lotus-med.ro
Site Name
Policlinica Providența
Department Name
Dermato Venereology
Contact Person Name
Elena Crihan
Contact Person Email
elenacrihan@outlook.com
Site Name
Centrul de Medicina de Familie
Department Name
Dermato Venereology
Contact Person Name
Petronela Cozma
Contact Person Email
petronelacozma@yahoo.com
Site Name
New Derm Clinical SRL
Department Name
Dermato Venereology
Contact Person Name
Stefania Avram
Contact Person Email
dr.avram.stefania@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
05-09-2025
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
223
Number Of Sites
3
Number Of Participants
12

Sites

Site Name
Universita Cattolica Del Sacro Cuore
Department Name
U.O.C Dermatology
Contact Person Name
Ketty Peris
Contact Person Email
ketty.peris@unicatt.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
U.O. C Dermatology
Contact Person Name
Luca Bianchi
Contact Person Email
luca.bianchi@uniroma2.it
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
Dermatology
Contact Person Name
Iria Neri
Contact Person Email
iria.neri@aosp.bo.it

Hungary

Earliest CTIS Part Ii Submission Date
06-08-2025
Latest Decision Or Authorization Date
16-04-2026
Processing Time Days
253
Number Of Sites
3
Number Of Participants
16

Sites

Site Name
University Of Debrecen
Department Name
University of Debrecen, DE Clinical Centre (DEKK), Health Service Units, Clinics, Dermatology Clinic
Contact Person Name
Andrea Szegedi
Contact Person Email
aszegedi@med.unideb.hu
Site Name
Clinexpert Kft.
Department Name
Clinexpert Budapest
Contact Person Name
Dorottya Asboth
Contact Person Email
info@clinexpert.hu
Site Name
University Of Szeged
Department Name
Department of Dermatology and Allergology
Contact Person Name
Zsanett Csoma
Contact Person Email
trial.office@szte.hu

Belgium

Earliest CTIS Part Ii Submission Date
15-09-2025
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
211
Number Of Sites
3
Number Of Participants
8

Sites

Site Name
Universitair Ziekenhuis Gent
Department Name
Dermatology
Contact Person Name
Sofie De Schepper
Contact Person Email
sofie.deschepper@uzgent.be
Site Name
Centre hospitalier universitaire de Liege
Department Name
Dermatology
Contact Person Name
Arjen Nikkels
Contact Person Email
af.nikkels@chuliege.be
Site Name
Cliniques Universitaires Saint-Luc
Department Name
Dermatology
Contact Person Name
Piere-Dominique Ghislain

Spain

Earliest CTIS Part Ii Submission Date
14-08-2025
Latest Decision Or Authorization Date
15-04-2026
Processing Time Days
244
Number Of Sites
5
Number Of Participants
15

Sites

Site Name
Grupo Pedro Jaen
Department Name
DERMATOLOGIA
Contact Person Name
ALVARO GONZALEZ CANTERO
Site Name
Hospital Sant Joan de Déu
Department Name
DERMATOLOGIA
Contact Person Name
ASUNCIÓN VICENTE VILLA
Contact Person Email
asuncion.vicente@sjd.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
DERMATOLOGIA
Contact Person Name
HELENA IZNARDO RUIZ
Contact Person Email
hiznardo@santpau.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
DERMATOLOGIA
Contact Person Name
RAQUEL RIVERA-DÍAZ
Contact Person Email
rriveradiaz@hotmail.com
Site Name
CHUS - Hospital Clinico Universitario
Department Name
DERMATOLOGIA
Contact Person Name
ISABEL RODRIGUEZ BLANCO

Poland

Earliest CTIS Part Ii Submission Date
08-09-2025
Latest Decision Or Authorization Date
20-04-2026
Processing Time Days
224
Number Of Sites
8
Number Of Participants
59

Sites

Site Name
Dermed Centrum Medyczne Sp. z o.o.
Contact Person Name
Andrzej Kaszuba
Contact Person Email
gabinety@dermed.com.pl
Site Name
Klinika Ambroziak Sp. z o.o.
Department Name
Klinika Ambroziak Dermatologia
Contact Person Name
Monika Kalowska
Contact Person Email
recepcja@klinikaambroziak.pl
Site Name
La Clinique Centrum Dermatologii i Estetyki
Contact Person Name
Monika Rogala
Contact Person Email
saskaderm@gmail.com
Site Name
LUXDERM Specjalistyczny Gabinet Dermatologiczny Prof. dr hab. n. med. Dorota Krasowska
Contact Person Name
Dorota Krasowska
Contact Person Email
dor.krasowska@gmail.com
Site Name
Specderm Poznanska Sp. j.
Contact Person Name
Maria Poznanska
Contact Person Email
specderm@gmail.com
Site Name
Futuremeds Sp. z o.o.
Department Name
Futuremeds Targowek
Contact Person Name
Patrycja Wislinska
Contact Person Email
info.targowek@futuremeds.com
Site Name
Etyka Osrodek Badan Klinicznych Tomasz Pesta S.K.A.
Department Name
Etyka Ośrodek Badań Klinicznych
Contact Person Name
Agata Maciejewska-Radomska
Contact Person Email
tomaszpesta@etykaosrodek.pl
Site Name
Royalderm Sp. z o.o.
Department Name
ROYALDERM Agnieszka Nawrocka
Contact Person Name
Witold Owczarek
Contact Person Email
badania.royalderm@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
Signant Health Global LLC
Responsibilities
Other - IVRS – treatment randomisation, Subject Number assignment, Treatment/Arm assignment, Drug (re)supplies assignment, PRO/COA
Name
Iqvia Inc.
Name
WCG Clinical Inc.
Responsibilities
Investigator Rater Trainings;
Name
Yprime LLC
Responsibilities
IVRS – treatment randomisation; Core Technology Services
Name
Q2 Solutions LLC
Responsibilities
Flow cytometry, Sample mgmt, Kit building, Storage and distribution of samples to other vendors for analysis

Third parties

  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Other - IVRS – treatment randomisation, Subject Number assignment, Treatment/Arm assignment, Drug (re)supplies assignment, PRO/COA","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Sample storage for IM011-1128","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"Flow cytometry, Sample mgmt, Kit building, Storage and distribution of samples to other vendors for analysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"Investigator Rater Trainings;","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Yprime LLC","duties_or_roles":"IVRS – treatment randomisation; Core Technology Services","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Other - 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 Rater Trainings","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
Investigational Product Name
deucravacitinib
Active Substance
DEUCRAVACITINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Investigational Product Name
Placebo to match deucravacitinib 6mg tablets in bottle, oral use
Modality
Other
Investigational Product Name
Placebo to match deucravacitinib 2mg minitablets in sachet, oral use
Modality
Other

Related trials

Other published trials that may interest you.