E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active Psoriatic Arthritis |
Artritis Psoriásica Activa (APs) |
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E.1.1.1 | Medical condition in easily understood language |
Active Psoriatic Arthritis |
Artritis Psoriásica Activa (APs) |
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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 |
Comparar la eficacia de deucravacitinib frente a placebo en el tratamiento de pacientes con APs activa |
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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 |
Comparar la eficacia de deucravacitinib frente a placebo en la semana 16: - evaluada por DAS28-PCR - evaluada por HAQ-DI - evaluada por la respuesta PASI 75 - evaluada por SF-36 PCS - evaluada por la resolución de la entesitis - evaluada por la respuesta MDA |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Participant has been diagnosed to have PsA (by any criteria) of at least 3 months duration at Screening. Participant meets the CASPAR criteria at Screening. Participant has active plaque psoriatic skin lesion(s) or documented medical history of plaque PsO at Screening. Participant has active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints (66/68 joint counts) at Screening and Day 1. Participant has hsCRP ≥ 3 mg/L at Screening. Participant has had documented inadequate response, loss of response or intolerance to at least 1 of the following: •A csDMARD at maximally tolerated dose, and/or apremilast, after a minimum of 12 weeks duration of therapy given for the treatment of PsA •An NSAID after a minimum of 4 weeks duration of therapy given for the treatment of PsA, or participant has intolerance to those treatments in the opinion of the investigator •A TNF-inhibitor after a minimum of 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilar), or a minimum of 14 weeks (i.e., at least 4 doses) of infliximab (or biosimilar) given for the treatment of PsA and/or PsO. A shorter duration may be considered if documentation of inadequate response can be obtained and provided to the Medical Monitor for review |
El paciente debe tener un diagnóstico de APs (por cualquier criterio) de al menos 3 meses de duración en la selección. Los pacientes deben cumplir los criterios CASPAR en la selección. El paciente tiene lesión o lesiones cutáneas de psoriasis en placas o antecedentes médicos documentados de PsO en placas en la selección. El paciente tiene artritis activa demostrada por ≥ 3 articulaciones inflamadas y ≥ 3 articulaciones dolorosas (recuentos de 66/68 articulaciones) en la selección y el día 1. El paciente tiene PCRas ≥ 3 mg/l en la selección. El paciente ha tenido respuesta inadecuada documentada, pérdida de respuesta, o intolerancia a al menos 1 de los siguientes: - Un FAMEsc a la máxima dosis tolerada después de un mínimo de duración de 12 semanas de terapia administrada para el tratamiento de la APs - Un AINE después de un mínimo de 4 semanas de duración de terapia administrada para el tratamiento de la APs, - Un TNFi después de un mínimo de 12 semanas de tratamiento con etanercept, adalimumab, golimumab o certolizumab pegol (o biosimilar), o un mínimo de 14 semanas (es decir, al menos 4 dosis) de infliximab (o biosimilar) administrado para el tratamiento de la APs y/o PsO. Se puede considerar una duración más corta si se han podido obtener y facilitar pruebas documentadas al monitor médico para su revisión |
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E.4 | Principal exclusion criteria |
Participant has non-plaque PsO (ie, guttate, pustular, erythrodermic or drug-induced PsO) at Screening or Day 1. Participant has any other autoimmune condition such as, systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis. Participant has prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease). Participant has active (ie, currently symptomatic) fibromyalgia whose symptoms or therapy will significantly impact the assessment of PsA disease manifestations and activity in the opinion of the investigator. |
Los pacientes tienen PsO sin placas (es decir, guttata, pustular, eritrodérmica o PsO inducida por fármacos) en la selección o el día 1. El paciente tiene otra afección autoinmunitaria, por ejemplo, lupus eritematoso sistémico, enfermedad por tejido conectivo mixto, esclerosis múltiple o vasculitis. El paciente tiene antecedentes de enfermedad articular inflamatoria diferente a la APs (por ejemplo, gota, artritis reactiva, artritis reumatoide, espondilitis anquilosante, enfermedad de Lyme). El paciente tiene fibromialgia activa (es decir, actualmente sintomática) cuyos síntomas o terapia afectarán significativamente a la evaluación de las manifestaciones de la enfermedad de la APs y actividad en opinión del investigador. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of participants meeting ACR 20 response |
Porcentaje de pacientes que cumplen la respuesta ACR 20 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
At Week 16 |
En la semana 16 |
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E.5.2 | Secondary end point(s) |
1- Change from baseline in DAS28-CRP score 1- Change from baseline in HAQ-DI score 1- Proportion of participants meeting PASI 75 response 1- Change from baseline in the SF-36 PCS 1- Proportion of participants meeting enthesitis resolution 1- Proportion of participants meeting achievement of MDA 1- Change from baseline in FACIT-Fatigue 1- Proportion of participants meeting dactylitis resolution
2- Additional Secondary Endpoints: Proportion of participants meeting ACR 20, ACR 50, and ACR 70 response Change from baseline in HAQ-DI score Proportion of participants who achieve a clinically meaningful improvement in HAQ-DI score Proportion of participants with achievement of PASI 75/90/100 response Change from baseline in the SF-36 PCS score Proportion of participants meeting enthesitis resolution Proportion of participants meeting achievement of MDA Change from baseline in SF-36 Score MCS Change from baseline in FACIT-Fatigue Proportion of participants meeting dactylitis resolution Change from baseline in PsAID 12 Change from baseline in DAPSA score Proportion of participants meeting achievement of PGA-F of 0/1 Change from baseline in DAS28-CRP score Change from baseline in PASDAS Change from baseline in mCPDAI score Proportion of participants achieving PsARC response Proportion of participants meeting achievement of improvement from baseline in BASDAI score Change from baseline in domain scales scores, PCS, and MCS of SF-36 Change from baseline in the subcomponents of the WPAI questionnaire Change from baseline in the 5-level EQ-5D utility scores and its subcomponents Change from baseline in PROMIS sleep disturbance (short form) |
1- Cambio desde el momento basal en la puntuación de DAS28-PCR 1- Cambio desde el momento basal en la puntuación del HAQ-DI 1- Porcentaje de pacientes que cumplen la respuesta PASI 75 1- Cambio desde el momento basal en el SF-36 PCS 1- Porcentaje de pacientes que cumplen la resolución de la entesitis 1- Porcentaje de pacientes que consiguen la MDA 1- Cambio desde el momento basal en la escala FACIT-Fatiga 1- Porcentaje de pacientes que cumplen la resolución de dactilitis
2- Criterios de valoración secundarios adicionales: Porcentaje de pacientes que cumplen la respuesta ACR 20, ACR 50, y ACR 70 Cambio desde el momento basal en la puntuación del HAQ-DI Porcentaje de pacientes que cumplen una mejoría clínicamente significativa del HAQ-DI Porcentaje de pacientes que cumplen la respuesta de PASI 75/90/100 Cambio desde el momento basal en la puntuación del SF-36 PCS Porcentaje de pacientes que cumplen la resolución de la entesitis Porcentaje de pacientes que consiguen la MDA Cambio desde el momento basal en la puntuación de SF-36 MCS Cambio desde el momento basal en la escala FACIT-Fatiga Porcentaje de pacientes que cumplen la resolución de dactilitis Cambio desde el momento basal en PsAID 12 Cambio desde el momento basal en la escala DAPSA Porcentaje de pacientes que consiguen la PGA-F de 0/1 Cambio desde el momento basal en la escala DAS28-CRP Cambio desde el momento basal en PASDAS Cambio desde el momento basal en la escala mCPDAI Porcentaje de pacientes que cumplen la respuesta de PsARC Porcentaje de pacientes que cumplen una mejoría desde el momento basa en la escala BASDAI Cambio desde el momento basal en las puntuaciones de las escalas de dominio PCS y MCS de SF-36 Cambio desde el momento basal en los subcomponentes del cuestionario WPAI Cambio desde el momento basal en las puntuaciones de utilidad de 5-level EQ-5D y sus subcomponentes Cambio desde el momento basal en PROMIS de la alteración del sueño (forma corta) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1- At Week 16 2- At Each Time Point up to Week 16 |
1- En la semana 16 2- En cada momento hasta la semana 16 |
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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 | 4 |
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 |
Brazil |
Chile |
China |
Colombia |
Mexico |
Russian Federation |
Taiwan |
Finland |
France |
Germany |
Hungary |
Ireland |
Italy |
Poland |
Romania |
Spain |
United Kingdom |
Czechia |
Argentina |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 13 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
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 | 5 |