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    Summary
    EudraCT Number:2020-005097-10
    Sponsor's Protocol Code Number:IM011-054
    National Competent Authority:Romania - National Agency for Medicines and Medical Devices
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2024-10-11
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedRomania - National Agency for Medicines and Medical Devices
    A.2EudraCT number2020-005097-10
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Psoriatic Arthritis who are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active Psoriatic Arthritis (PsA) who are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
    A.3.2Name or abbreviated title of the trial where available
    POETYK PsA-1
    A.4.1Sponsor's protocol code numberIM011-054
    A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1259-9443
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorBristol-Myers Squibb International Corporation
    B.1.3.4CountryBelgium
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBristol-Myers Squibb International Corporation
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBristol-Myers Squibb International Corporation
    B.5.2Functional name of contact pointGSM-CT
    B.5.3 Address:
    B.5.3.1Street AddressParc de l'Alliance - Avenue de Finlande, 4
    B.5.3.2Town/ cityBraine-l'Alleud
    B.5.3.3Post code1420
    B.5.3.4CountryBelgium
    B.5.6E-mailclinical.trials@bms.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedeucravacitinib
    D.3.2Product code BMS-986165
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNdeucravacitinib
    D.3.9.1CAS number 1609392-27-9
    D.3.9.2Current sponsor codeBMS-986165
    D.3.9.3Other descriptive nameBMS986165
    D.3.9.4EV Substance CodeSUB180283
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Active Psoriatic Arthritis
    E.1.1.1Medical condition in easily understood language
    Active Psoriatic Arthritis
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the efficacy of deucravacitinib to placebo in the treatment of participants with active PsA
    E.2.2Secondary objectives of the trial
    To compare the efficacy of deucravacitinib to placebo at Week 16:
    - as assessed by DAS28-CRP
    - as assessed by HAQ-DI score
    - as assessed by PASI 75 response
    - as assessed by SF-36 PCS score
    - in enthesitis resolution
    - in MDA response
    - in FACIT-Fatigue
    - in dactylitis resolution
    - as assessed by structural damage
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening
    • Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening
    • Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at screening
    • Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and day 1
    • Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening
    • ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading
    E.4Principal exclusion criteria
    • Nonplaque psoriasis at screening or day 1
    • Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis
    • History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis,
    Lyme disease)
    • Active fibromyalgia
    • Received an approved or investigational biologic therapy for the treatment of PsA or PsO

    Other protocol-defined inclusion/exclusion criteria apply
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR 20) response
    E.5.1.1Timepoint(s) of evaluation of this end point
    At Week 16
    E.5.2Secondary end point(s)
    1. Change from baseline in Disease Activity Score 28 with C-reactive protein (DAS28-CRP) score
    2. Change from baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) score
    3. Proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response
    4. Change from baseline in the Short Form-36 Physical Component Survey (SF-36 PCS)
    5. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Leeds Enthesitis Index (LEI)
    6. Proportion of participants meeting achievement of Minimal Disease Activity (MDA)
    7. Change from baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
    8. Proportion of participants meeting dactylitis resolution at week 16 among the participants with dactylitis at baseline
    9. Change from baseline in PsA-modified Sharp-van der Heijde (SvdH) score
    10. Proportion of participants meeting ACR 20 response
    11. Proportion of participants meeting ACR improvement of 50% (ACR50) response
    12. Proportion of participants meeting ACR improvement of 70% (ACR70) response
    13. Change from baseline in HAQ-DI score
    14. Proportion of participants who achieve a clinically meaningful improvement (≥ 0.35 improvement from baseline) in HAQ-DI score
    among participants with a HAQ-DI score ≥ 0.35 at baseline
    15. Proportion of participants with achievement of PASI 75 response
    16. Proportion of participants with achievement of PASI 90 response
    17. Proportion of participants with achievement of PASI 100 response
    18. Change from baseline in the SF-36 PCS score
    19. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by LEI
    20. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Spondyloarthritis Research
    Consortium of Canada (SPARCC)
    21. Proportion of participants meeting achievement of MDA
    22. Change from baseline in SF-36 Score Mental Component Summary (MCS)
    23. Change from baseline in FACIT-Fatigue
    24. Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline
    25. Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12
    26. Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score
    27. Proportion of participants with achievement of DAPSA low disease activity response
    28. Proportion of participants with achievement of DAPSA disease remission
    29. Proportion of participants meeting achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1 in participants with a baseline PGA-F score of ≥ 3
    30. Change from baseline in DAS28-CRP score
    31. Proportion of participants with achievement of a DAS28-CRP low disease activity response
    32. Proportion of participants with achievement of a DAS28-CRP disease remission
    33. Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
    34. Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score
    35. Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC)
    36. Proportion of participants meeting achievement of improvement from baseline in Bath Ankylosing Spondylitis Disease Activity Index
    (BASDAI) score among participants with spondylitis in addition to peripheral joint involvement as their presentation of PsA 37, 38, 39. Proportion of participants meeting achievement of total PsA
    modified SvdH score of ≤ 0, ≤ 0.5 & ≤ smallest detectable change (SDC)
    40. Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ 0
    41. Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤ 0.5
    42. Proportion of participants meeting achievement of PsA-modified SvdH erosion score change of ≤SDC
    43. Proportion of participants meeting achievement of PsA-modified SvdH joint space narrowing (JSN)score change of ≤ 0
    44. Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of ≤ 0.5
    45. Proportion of participants meeting achievement of PsA-modified SvdH JSN score change of ≤ SDC
    46. Change in PsA-modified SvdH erosion score from baseline
    47. Change in PsA-modified SvdH JSN score
    48. Change from baseline in domain scales scores of SF-36
    49. Change from baseline in PCS of SF-36
    50. Change from baseline in MCS of SF-36
    51. Change from baseline in subcomponents of the Work Productivity and Activity Impairment(WPAI) questionnaire
    52. Change from baseline in 5-level EuroQoL 5-dimension (EQ-5D) utility scores
    53. Change from baseline in 5-level EQ-5D utility score subcomponents
    54. Change from baseline in Patient-Reported Outcome Measures Information System (PROMIS) sleep disturbance (short form)
    55. Incidence of adverse events (AEs)
    56. Incidence of serious adverse events (SAEs)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1 - 9 = At Week 16
    10 - 36 = Up to 16 weeks
    37 - 47 = At Week 16
    48 - 54 = Up to 16 weeks
    55 & 56 = Up to Week 52
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned14
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA67
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Chile
    Colombia
    Taiwan
    Brazil
    China
    Mexico
    Russian Federation
    United Kingdom
    Czechia
    Finland
    France
    Germany
    Hungary
    Ireland
    Italy
    Poland
    Romania
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days6
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 1092
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 208
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 740
    F.4.2.2In the whole clinical trial 1300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Participants completing 52 weeks of treatment in this study may be offered the opportunity to continue treatment with deucravacitinib in a long-term extension or a separate follow-up study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-06-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-09-27
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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