Clinical trial • Phase III • Musculoskeletal
DEUCRAVACITINIB for Juvenile psoriatic arthritis (JPsA)
Phase III trial of DEUCRAVACITINIB for Juvenile psoriatic arthritis (JPsA).
Overview
- Trial Therapeutic Area
- Musculoskeletal
- Trial Disease
- Juvenile psoriatic arthritis (JPsA)
- Trial Stage
- Phase III
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 15-10-2024
- First CTIS Authorization Date
- 18-02-2025
Trial design
Randomised, deucravacitinib placebo 2mg film-coated tablets in sachet, oral use (placebo comparator). dose/schedule not specified in available metadata.-controlled Phase III trial across 13 sites in Italy, Czechia, Bulgaria and others.
- Randomised
- Yes
- Comparator
- Deucravacitinib placebo 2mg film-coated tablets in sachet, oral use (placebo comparator). Dose/schedule not specified in available metadata.
- Target Sample Size
- 35
Eligibility
Recruits 35 paediatric patients.
- Vulnerable Population
- The trial includes a vulnerable population: children and adolescents aged 5 to less than 18 years. Age-appropriate assent and consent procedures are defined: parental/legal representative consent and pediatric assent forms are provided (documents and filenames indicate ICFs and assent forms for age groups such as 5-12, 6-11, 12-14, 13-17 and parent/legal representative forms). Multiple country-specific ICF/assent documents are included in the submission (e.g., English, German, Spanish, Bulgarian, Italian versions are present in the document list).
Inclusion criteria
- {"criterion_text":"- Participants need to have been diagnosed with JPsA. This means a participant has arthritis and skin problems like Psoriasis (PsO), or arthritis with other symptoms like swollen fingers or toes (dactylitis), changes in nails, or a close family member with PsO.\n- Participants need to have at least three joints that are affected by arthritis. This could mean that these joints are swollen, painful, or don't move as well as they should.\n- Participants should have tried at least one type of medicine for JPsA for at least three months, but it didn't work well or caused problems\n- Participants need to have been diagnosed with JPsA. This means a participant has arthritis and skin problems like Psoriasis (PsO), or arthritis with other symptoms like swollen fingers or toes (dactylitis), changes in nails, or a close family member with PsO.\n- Participants need to have at least three joints that are affected by arthritis. This could mean that these joints are swollen, painful, or don't move as well as they should.\n- Participants should have tried at least one type of medicine for JPsA for at least three months, but it didn't work well or caused problems"}
Exclusion criteria
- {"criterion_text":"- Diagnosis of JPsA before 5 years of age, or certain substances in the blood like Antinuclear Antibodies (ANA) or Rheumatoid Factor (RF) above a certain level.\n- Have other types of Juvenile Idiopathic Arthritis (JIA) that aren't JPsA.\n- Have a history of chronic eye inflammation (uveitis), or were diagnosed with uveitis within the last three months\n- Diagnosis of JPsA before 5 years of age, or certain substances in the blood like Antinuclear Antibodies (ANA) or Rheumatoid Factor (RF) above a certain level.\n- Have other types of Juvenile Idiopathic Arthritis (JIA) that aren't JPsA.\n- Have a history of chronic eye inflammation (uveitis), or were diagnosed with uveitis within the last three months"}
Endpoints
Primary endpoints
- {"endpoint_text":"- To see how long it takes for the first flare-up of the disease to happen between weeks 16 to 42 in participants who take the medication compared to participants who stopped taking the drug.","definition_or_measurement_approach":"Time-to-event measure: time to first disease flare between weeks 16 and 42 comparing active treatment versus randomized withdrawal (placebo/stopped drug)."}
- {"endpoint_text":"- To see how long it takes for the first flare-up of the disease to happen between weeks 16 to 42 in participants who take the medication compared to participants who stopped taking the drug.","definition_or_measurement_approach":"Time-to-event measure: time to first disease flare between weeks 16 and 42 comparing active treatment versus randomized withdrawal (placebo/stopped drug)."}
Secondary endpoints
- {"endpoint_text":"- Evaluating amount of deucravacitinib in the body at week 16.","definition_or_measurement_approach":"Pharmacokinetic measurement (drug concentration) at Week 16 (PK sampling/assay)."}
- {"endpoint_text":"- Assessing how many participants have a flare-up and how many reach different levels of improvement at weeks 16 and 42. Assessing how much the disease has improved from start of the trial and how many have low disease activity or no disease activity at weeks 16 and 42. Assessing how many participants have no disease activity for at least 6 months in a row. Assessing how many have a 75% improvement in their skin symptoms by week 42","definition_or_measurement_approach":"Responder and disease activity measures at Weeks 16 and 42: counts of flares, categorical improvement levels from baseline, low/no disease activity status, sustained remission (≥6 months), and skin improvement (e.g., 75% improvement metric) assessed using disease-specific activity and skin outcome instruments."}
- {"endpoint_text":"- Assessing how many participants find the medicine easy to swallow and taste good at week 16.","definition_or_measurement_approach":"Participant-reported palatability and swallowability assessed at Week 16 (questionnaire/acceptability instrument)."}
- {"endpoint_text":"- Assessing how the amount of medicine in the body affects the results at week 16.","definition_or_measurement_approach":"Exposure-response (E-R) analyses linking PK (drug concentrations) at Week 16 to efficacy/safety outcomes."}
- {"endpoint_text":"- Monitoring any side effects, how severe they are, and if they cause anyone to stop the trial. Assessing how many participants develop an eye condition called uveitis.","definition_or_measurement_approach":"Safety monitoring: adverse event reporting and severity grading, discontinuations due to AEs, and specific incidence of uveitis throughout study follow-up."}
- {"endpoint_text":"- Evaluating amount of deucravacitinib in the body at week 16.","definition_or_measurement_approach":"Pharmacokinetic measurement (drug concentration) at Week 16 (PK sampling/assay)."}
- {"endpoint_text":"- Seeing how many people have a flare-up between weeks 16 to 42.","definition_or_measurement_approach":"Incidence (count) of disease flares occurring in the window Weeks 16–42."}
- {"endpoint_text":"- Assessing how many participants find the medicine easy to swallow and taste good at week 16.","definition_or_measurement_approach":"Participant-reported palatability and swallowability at Week 16 (questionnaire)."}
- {"endpoint_text":"- Assessing how the amount of medicine in the body affects the results at week 16.","definition_or_measurement_approach":"Exposure-response analyses linking Week 16 PK to clinical outcomes."}
- {"endpoint_text":"- Monitoring any side effects, how severe they are, and if they cause anyone to stop the trial. Assessing how many participants develop an eye condition called uveitis.","definition_or_measurement_approach":"Safety monitoring including AE severity, discontinuations, and incidence of uveitis assessed throughout follow-up."}
Recruitment
- Planned Sample Size
- 35
- Recruitment Window Months
- 73
- Consent Approach
- Informed consent is obtained from parent(s)/legal representatives; age-appropriate assent is obtained from pediatric participants. Multiple subject information and informed consent/assent documents are included for different age groups (e.g., 5-12, 6-11, 12-14, 13-17) and for parents/legal representatives. Country- and language-specific ICF/assent materials are provided (document list includes English, German, Spanish, Bulgarian, Italian versions among others).
Geography
- Total Number Of Sites
- 13
- Total Number Of Participants
- 29
Italy
- Earliest CTIS Part Ii Submission Date
- 27-01-2025
- Latest Decision Or Authorization Date
- 31-03-2026
- Processing Time Days
- 428
- Number Of Sites
- 2
- Number Of Participants
- 3
Sites
- Site Name
- Azienda Ospedaliera Universitaria Meyer IRCCS
- Department Name
- Dipartimento di Scienze Mediche Traslazionali
- Principal Investigator Name
- Roberta Naddei
- Principal Investigator Email
- roberta.naddei@unina.it
- Contact Person Name
- Roberta Naddei
- Contact Person Email
- roberta.naddei@unina.it
- Site Name
- Azienda Ospedaliera Universitaria Federico II Di Napoli
- Department Name
- SOSa Pediatric Rheumatology
- Principal Investigator Name
- Gabriele Simonini
- Principal Investigator Email
- gabriele.simonini@unifi.it
- Contact Person Name
- Gabriele Simonini
- Contact Person Email
- gabriele.simonini@unifi.it
Czechia
- Earliest CTIS Part Ii Submission Date
- 31-01-2025
- Latest Decision Or Authorization Date
- 02-04-2026
- Processing Time Days
- 426
- Number Of Sites
- 2
- Number Of Participants
- 2
Sites
- Site Name
- Fakultni Nemocnice V Motole
- Department Name
- Oddeleni revmatologie deti a dospelych
- Principal Investigator Name
- Rudolf Horvath
- Principal Investigator Email
- rudolf.horvath@fnmotol.cz
- Contact Person Name
- Rudolf Horvath
- Contact Person Email
- rudolf.horvath@fnmotol.cz
- Site Name
- University Hospital Olomouc
- Department Name
- Detska klinika
- Principal Investigator Name
- Katerina Bouchalova
- Principal Investigator Email
- katerina.bouchalova@fnol.cz
- Contact Person Name
- Katerina Bouchalova
- Contact Person Email
- katerina.bouchalova@fnol.cz
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 12-02-2025
- Latest Decision Or Authorization Date
- 22-04-2026
- Processing Time Days
- 434
- Number Of Sites
- 2
- Number Of Participants
- 10
Sites
- Site Name
- Medical Center for Specialized Care for Cardiovascular Diseases EAD
- Principal Investigator Name
- Stefan Stefanov
- Principal Investigator Email
- info@cardio-center.eu
- Contact Person Name
- Stefan Stefanov
- Contact Person Email
- info@cardio-center.eu
- Site Name
- University Multiprofile Hospital For Active Treatment Saint Georgi EAD
- Department Name
- Clinic of Pediatrics Level III
- Principal Investigator Name
- Krastina Stefanova-Kelly
- Principal Investigator Email
- krastinakelly@yahoo.co.uk
- Contact Person Name
- Krastina Stefanova-Kelly
- Contact Person Email
- krastinakelly@yahoo.co.uk
Romania
- Earliest CTIS Part Ii Submission Date
- 28-10-2024
- Latest Decision Or Authorization Date
- 06-04-2026
- Processing Time Days
- 525
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Spitalul Clinic De Urgenta Pentru Copii Cluj-Napoca
- Department Name
- Reumatology
- Principal Investigator Name
- Mihaela Sparchez
- Principal Investigator Email
- pediatrie2@spitcocluj.ro
- Contact Person Name
- Mihaela Sparchez
- Contact Person Email
- pediatrie2@spitcocluj.ro
- Site Name
- Medaudio-Optica S.R.L.
- Department Name
- Reumatology
- Principal Investigator Name
- Razvan Constantin Ionitescu
- Principal Investigator Email
- albc@yahoo.com
- Contact Person Name
- Razvan Constantin Ionitescu
- Contact Person Email
- albc@yahoo.com
Spain
- Earliest CTIS Part Ii Submission Date
- 27-11-2024
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 496
- Number Of Sites
- 3
- Number Of Participants
- 3
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Pediatric Rheumatology
- Principal Investigator Name
- Lucia La Cruz
- Principal Investigator Email
- lacruz_lucper@gva.es
- Contact Person Name
- Lucia La Cruz
- Contact Person Email
- lacruz_lucper@gva.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Pediatric Rheumatology
- Principal Investigator Name
- MIREIA LOPEZ
- Principal Investigator Email
- mireia.lopez@vhir.org
- Contact Person Name
- MIREIA LOPEZ
- Contact Person Email
- mireia.lopez@vhir.org
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Pediatric Rheumatology
- Principal Investigator Name
- Alina Boteanu
- Principal Investigator Email
- XXXX@XXXX.XX
- Contact Person Name
- Alina Boteanu
- Contact Person Email
- XXXX@XXXX.XX
Germany
- Earliest CTIS Part Ii Submission Date
- 25-04-2025
- Latest Decision Or Authorization Date
- 07-04-2026
- Processing Time Days
- 347
- Number Of Sites
- 2
- Number Of Participants
- 5
Sites
- Site Name
- Zentrum Fuer Kinder Und Jugendrheumatologie
- Department Name
- Pediatric rheumatology
- Principal Investigator Name
- Ivan Foeldvari
- Principal Investigator Email
- foeldvari@t-online.de
- Contact Person Name
- Ivan Foeldvari
- Contact Person Email
- foeldvari@t-online.de
- Site Name
- Universitaetsklinikum Erlangen AöR
- Department Name
- University Children's Hospital Nephrology, Rheumatology
- Principal Investigator Name
- Tobias Krickau
- Principal Investigator Email
- tobias.krickau@uk-erlangen.de
- Contact Person Name
- Tobias Krickau
- Contact Person Email
- tobias.krickau@uk-erlangen.de
Sponsor
Primary sponsor
- Full Name
- Bristol-Myers Squibb Services Unlimited Company
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Ireland
Contract research organisations
- Name
- Iqvia Inc.
- Responsibilities
- Site Payments
- Name
- Medidata Solutions Inc.
- Responsibilities
- Data Management Platform
- Name
- Q2 Solutions LLC
- Responsibilities
- Bioanalytical testing
Third parties
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Pharmacovigilance duties: Medical review and Cases Data Entry","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"Bioanalytical testing","organisation_type":"Laboratory/Research/Testing facility"}
- {"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":"Medidata Solutions Inc.","duties_or_roles":"Data Management Platform","organisation_type":"Non-Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"Embarc operations","organisation_type":"Non-Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"submission administrative support","organisation_type":"Pharmaceutical company"}
- {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Long-Term Sample storage for IM011-1071","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"Site Payments","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 comunications to patients","organisation_type":"Non-Pharmaceutical company"}
- {"country":"India","full_name":"Accenture Solutions Private Limited","duties_or_roles":"","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
- Maximum Dose
- 6 mg (max daily dose)
- Investigational Product Name
- Deucravacitinib placebo 2mg film-coated tablets in sachet, oral use
- Modality
- Other
- Routes Of Administration
- ORAL
- Route
- oral
- Authorisation Status
- Not applicable
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