E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active Psoriatic Arthritis |
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E.1.1.1 | Medical condition in easily understood language |
Active Psoriatic Arthritis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the efficacy of deucravacitinib to placebo in the treatment of participants with active PsA |
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E.2.2 | Secondary 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 - 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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) atScreening • 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 |
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E.4 | Principal 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, rheumatoidarthritis, 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1. Change from baseline Disease Activity Score 28 and C-Reactive Protein (DAS28-CRP) 2. Change from baseline Health Assessment Questionnaire - Disability Index (HAQ-DI) 3. Proportion of participants meeting Psoriatic Area and Severity Index (PASI) 75 response 4. Change from baseline 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 among the participants with dactylitis at baseline 9. Proportion of participants meeting ACR 20 response 10. Proportion of participants meeting American College of Rheumatology improvement of 50% (ACR50) response 11. Proportion of participants meeting American College of Rheumatology improvement of 70% (ACR70) response 12. Change from baseline in HAQ-DI score 13. 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 14. Proportion of participants meeting PASI 75 response 15. Proportion of participants meeting PASI 90 response 16. Proportion of participants meeting PASI 100 response 17. Change from baseline in the SF-36 PCS score 18. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by LEI 19. Proportion of participants meeting enthesitis resolution among participants with enthesitis at baseline by Spondyloarthritis Research Consortium of Canada (SPARCC) 20. Proportion of participants meeting achievement of MDA 21. Change from baseline in SF-36 Score Mental Component Summary (MCS) 22. Change from baseline in FACIT-Fatigue 23. Proportion of participants meeting dactylitis resolution among the participants with dactylitis at baseline 24. Change from baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 25. Change from baseline in Disease Activity Index for Psoriatic Arthritis Score (DAPSA) score 26. Proportion of participants with achievement of DAPSA low disease activity response 27. Proportion of participants with achievement of DAPSA disease remission 28. 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 29. Change from baseline in DAS28-CRP score 30. Proportion of participants with achievement of a DAS28-CRP low disease activity response 31. Proportion of participants with achievement of a DAS28-CRP disease remission 32. Change from baseline in Psoriatic Arthritis Disease Activity Score (PASDAS) 33. Change from baseline in modified Composite Psoriatic Disease Activity Index (mCPDAI) score 34. Proportion of participants achieving Psoriatic Arthritis Response Criteria (PsARC) 35. Proportion of participants meeting achievement of improvement from baseline in Bath AnkylosingSpondylitis Disease Activity Index (BASDAI) score among participants with spondylitis in addition toperipheral joint involvement as their presentation of PsA 36. Change from baseline in domain scales scores of SF-36 37. Change from baseline in PCS of SF-36 38. Change from baseline in MCS of SF- 36 39. Change from baseline in the subcomponents of the Work Productivity and Activity Impairment(WPAI) questionnaire 40. Change from baseline in the 5-level EuroQoL 5-dimension (EQ-5D) utility scores 41. Change from baseline in the 5-level EQ-5D utility score subcomponents 42. Change from baseline in Patient- Reported Outcome Measures Information System (PROMIS) sleepdisturbance (short form) 43. Incidence of Adverse Events (AEs) 44. Incidence of Serious Adverse Events (SAEs) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 - 8 = At Week 16 9 - 42 = Up to 16 weeks 43 & 44 = Up to Week 52 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 38 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Brazil |
Chile |
China |
Colombia |
Mexico |
Taiwan |
Russian Federation |
Czechia |
Finland |
France |
Germany |
Hungary |
Ireland |
Italy |
Poland |
Romania |
Spain |
United Kingdom |
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E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 19 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 2 |