E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Active Psoriatic Arthritis | Artritis psoriásica activa | |
E.1.1.1 | Medical condition in easily understood language | Chronic, inflammatory disease of the joints and the places where tendons and ligaments connect to bone. | Enfermedad inflamatoria crónica de las articulaciones y los lugares donde los tendones y ligamentos se conectan al hueso. | |
E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
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 | |
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 evaluate the efficacy of 3 different dose regimens of sonelokimab (120 mg once every 2 weeks [Q2W], 60 mg Q2W, and 60 mg once every 4 weeks [Q4W]) compared with placebo in the treatment of participants with active psoriatic arthritis (PsA). | Evaluar la eficacia de 3 pautas posológicas diferentes de sonelokimab (120 mg una vez cada 2 semanas [C2S], 60 mg C2S y 60 mg una vez cada 4 semanas [C4S]) en comparación con placebo en el tratamiento de participantes con artritis psoriásica (APs) activa | |
E.2.2 | Secondary objectives of the trial | 1. To evaluate the safety and tolerability of 3 different dose regimens of sonelokimab (120 mg Q2W, 60 mg Q2W, and 60 mg Q4W) compared with placebo in the treatment of participants with active PsA; 2. To assess the pharmacokinetics (PK) and immunogenicity of 3 different dose regimens of sonelokimab (120 mg Q2W, 60 mg Q2W, and 60 mg Q4W) in the treatment of participants with active PsA. | 1. Evaluar la seguridad y la tolerabilidad de 3 pautas posológicas diferentes de sonelokimab (120 mg C2S, 60 mg C2S y 60 mg C4S) en comparación con placebo en el tratamiento de participantes con APs activa. 2. Evaluar la farmacocinética (FC) y la inmunogenia de 3 pautas posológicas diferentes de sonelokimab (120 mg C2S, 60 mg C2S y 60 mg C4S) en el tratamiento de participantes con APs activa. | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria | 1. Participant is ≥18 years of age; 2. Participant has a confirmed diagnosis of PsA per the 2006 ClASsification criteria for Psoriatic ARthritis (CASPAR) with symptoms for ≥6 months prior to the Screening Visit; 3. Participant has active disease (defined by a TJC68 of ≥3 and a SJC66 of ≥3); 4. Participant has either current active PsO or a history of PsO; in either case, this diagnosis must have been confirmed by a dermatologist; 5. Participant tests negative for rheumatoid factor (RF) at the Screening Visit; 6. Participant tests negative for anti-cyclic citrullinated peptide (CCP) antibodies at the Screening Visit; 7. Participant must be, in the opinion of the investigator at both the Screening Visit and study treatment initiation, a suitable candidate for treatment with adalimumab per approved local product information. If a chest X-ray or computer tomography (CT) scan for tuberculosis (TB) screening is required per local guidance, the X-ray or CT scan must be taken within 3 months prior to the Screening Visit; 8. Participant has had an inadequate response at the Screening Visit (lack of efficacy after ≥12-week duration of therapy) to previous or current treatment with ≥1 non-biologic disease-modifying anti-rheumatic drug (DMARD) at maximally tolerated dose, or participant has an intolerance to or contraindication for DMARDs as defined by the investigator; 9. If the participant is female, she must be of non-childbearing potential or – if of childbearing potential, participant must agree to use highly effective methods of contraception. 10. Women of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) pregnancy test at the Screening Visit and a negative urine pregnancy test at Week 0/Day 1 prior to the first administration of study treatment; 11. If male, participant must be willing to use a condom when sexually active with a partner of childbearing potential during the study and for 12 weeks after the last dose of study treatment, unless surgically sterile; 12. Participant is considered reliable and capable of adhering to the protocol, visit schedule, or medication intake according to the judgment of the investigator; 13. Participant is able to understand and provide signed informed consent. | 1.El participante tiene ≥18 años de edad. 2.El participante tiene un diagnóstico confirmado de APs conforme a los criterios de la Clasificación de la artritis psoriásica de 2006 (CASPAR) y ha presentado síntomas durante ≥6 meses anteriores a la visita de selección. 3.La enfermedad del participante está activa (definido por un TJC68 ≥3 y un SJC66 ≥3). 4.El participante presenta psoriasis activa o antecedentes de psoriasis confirmados por un dermatólogo. 5.El participante obtiene un resultado negativo en la prueba de anticuerpos reumatoideos (AR) en la visita de selección. 6.El participante obtiene un resultado negativo en la prueba de anticuerpos contra el péptido cíclico citrulinado (PCC) en la visita de selección. 7.El participante debe ser, a criterio del investigador un candidato adecuado para el tratamiento con adalimumab conforme a la información sobre el producto autorizada local. Si, con arreglo a las directrices locales, es necesario hacer una tomografía computarizada (TC) o radiografía torácica para detectar la tuberculosis (TB), dicha TC o radiografía debe llevarse a cabo durante los 3 meses anteriores a la visita de selección. 8.El participante ha presentado una respuesta inadecuada en la visita de selección (falta de eficacia tras ≥12 semanas de tratamiento) al tratamiento previo o actual con ≥1 fármaco antirreumático modificador de la enfermedad (FARME) en la dosis máxima tolerada, o el participante ha sufrido una intolerancia o contraindicación a los FARME, conforme a lo definido por el investigador. 9.Si la participante es mujer, no debe tener capacidad para quedar embarazada o, si la tiene, debe aceptar utilizar métodos anticonceptivos de gran eficacia. 10.Las mujeres con capacidad de quedarse embarazadas deben haber obtenido un resultado negativo en la prueba de embarazo de coriogonadotropina (hCG) humana en suero realizada en la visita de selección, además de un resultado negativo en la prueba de embarazo en orina realizada en la semana 0/día 1 antes de la primera administración del tratamiento del estudio. 11.Si el participante es hombre, debe estar dispuesto a utilizar un preservativo al mantener relaciones sexuales con una pareja que puede quedarse embarazada durante el estudio y las 12 semanas posteriores a la última dosis del tratamiento del estudio, salvo que sea estéril por intervención quirúrgica. 12.Al participante se le considera fiable y capaz de cumplir con el protocolo, el calendario de visitas o la ingesta de medicamentos, a criterio del investigador. 13.El participante puede entender y proporcionar el consentimiento informado firmado. | |
E.4 | Principal exclusion criteria | 1. Known hypersensitivity to sonelokimab, adalimumab or any of its excipients; 2. Subjects who currently uses or plans to use 1 or more prohibited treatments specified in this protocol. Prohibited treatments and washout periods detailed in the protocol must be adhered to; 3. Subjects who has previously failed on anti (IL)-17 therapy, after at least 16 weeks of treatment; or is unsuitable for anti-IL-17 therapy for any reason according to the investigator’s discretion; 4. Subjects who has previously failed on anti-tumor necrosis factor alpha (TNFα) therapy, after at least 16 weeks of treatment; or is unsuitable for anti-TNFα therapy for any other reason according to the investigator’s discretion; 5. Subjects who has had previous exposure to more than 2 biologic agents of any type to treat PsA prior to the Screening Visit, including but not limited to IL-17 inhibitors, IL-23 inhibitors, TNFα inhibitors, etc; 6. Subjects who has a diagnosis of chronic inflammatory conditions other than PsO or PsA, including but not limited to rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus, Crohn’s disease, or ulcerative colitis; 7. Has a diagnosis of arthritis mutilans; 8. Has an active infection or history of infections, as defined in the protocol; 9. Subjects who received a live (including attenuated) vaccination within 8 weeks before study treatment initiation, or planned to receive a live vaccination during the study and up to at least 12 weeks after the last dose of study treatment. Examples of restricted vaccinations provided in the protocol; 10. Subjects who received a Bacillus Calmette-Guérin (BCG) vaccination within 1 year before study treatment initiation; 11. Participant with: a. A history of active tuberculosis (TB). b. Evidence of TB infection, unless the criteria as defined by the protocol apply. 12. Any current nontuberculous mycobacterial (NTM) infection or any history of pulmonary NTM infection at the Screening Visit; 13. Evidence of acute ocular inflammation, including active anterior uveitis (i.e., acute episode), within the last 4 weeks before study treatment initiation; 14. Concurrent malignancy or a history of malignancy during the past 5 years of the Screening Visit, exceptions providing in the protocol; 15. Subjects with fibromyalgia, osteoarthritis symptoms, or any other condition that in the investigator’s opinion may potentially interfere with efficacy assessments; 16. Subjects with erythrodermic, guttate, or pustular form of PsO or drug-induced PsO; 17. History of a lymphoproliferative disorders, including lymphoma, or current signs and symptoms suggestive of lymphoproliferative disease; 18. Primary immunodeficiencies, prior splenectomy, or suppressive conditions, including participants taking immunosuppressive therapy following organ transplants; 19. Had major surgery (including joint surgery) within 6 months, or is planning to have major surgery during the study; 20. Presence of active suicidal ideation, or positive suicidal behaviour, shows any history of suicidal attempt (including an actual attempt, interrupted attempt, or aborted attempt), or suicidal ideation in the past 6 months; 21. Subjects has presence of moderately severe depression or severe depression, indicated by a score of ≥15 using the screening PHQ-9. Subjects are permitted to use 1 medication to treat depression provided dose is stable for 4 weeks prior to initiation of study treatment. Subjects on multiple medications for depression are excluded from the study; 22. Severe cardiovascular comorbidities including history of myocardial infarction, unstable angina pectoris, stroke, heart failure, or uncontrolled hypertension; 23. Clinically significant ECG abnormalities on centrally read ECG at the Screening Visit; 24. Any other clinically significant medical conditions or any other reason, including any physical, psychological, or psychiatric condition, that would compromise the safety or interfere with participation in the study, would make the subjects an unsuitable candidate to receive study treatment, or would put the subjects at risk; 25. Subjects with laboratory abnormalities at the Screening Visit, as defined by the protocol; 26. Subjects is enrolled in another interventional investigational device or drug study, or has been in another investigational device or drug study in the last 28 days or within 5 half-lives of the investigational study treatment prior to the Screening Visit, whichever is greater; 27. Subjects is pregnant or breastfeeding, or plans to become pregnant while enrolled in the study and up to 12 weeks after the last dose of study treatment; 28. History of chronic alcohol or drug abuse in the past year prior to the Screening Visit; 29. Subjects is an employee, or direct relative of an employee, of the sponsor, at a study site, or of a third-party organization involved in the study. | 1.Hipersensibilidad conocida a sonelokimab o a cualquiera de sus excipientes.2.El participante utiliza en la actualidad o tiene previsto utilizar uno o más tratamientos prohibidos especificados en el protocolo. Los tratamientos prohibidos y los periodos de reposo farmacológico se proporcionan en el protocolo.3.El participante no ha respondido previamente a un tratamiento con antiinterleucina (IL)-17, después de al menos 16 semanas de tratamiento; o no es un candidato idóneo para recibir tratamiento con anti-IL-17 por cualquier motivo, a criterio del investigador.4.El participante no ha respondido previamente a un tratamiento con un fármaco antifactor de necrosis tumoral α (FNTα), después de al menos 16 semanas de tratamiento; o no es un candidato idóneo para recibir tratamiento con un anti-FNTα por cualquier motivo, a criterio del investigador.5.El participante ha estado expuesto previamente a más de 2 productos biológicos de cualquier tipo para tratar la APs antes de la visita de selección, incluidos, entre otros, inhibidores de IL 17, inhibidores de IL 23, inhibidores del FNTα, etc.6.El participante tiene un diagnóstico de trastornos inflamatorios crónicos distintos a la psoriasis o a la APs, incluidos, entre otros, la artritis reumatoide, la sarcoidosis, el lupus eritematoso sistémico, la enfermedad de Crohn o la colitis ulcerosa.7.El participante tiene un diagnóstico de artritis mutilante.8.El participante presenta una infección activa o antecedentes de infección, como se define en el protocolo.9.El participante ha recibido una vacuna elaborada con microbios vivos (incluidos atenuados) durante las 8 semanas anteriores al comienzo del tratamiento del estudio, o tiene previsto recibir una vacuna con microbios vivos durante el estudio y hasta, como mínimo, 12 semanas después de la última dosis del tratamiento del estudio. Ejemplos de vacunas restringidas proporcionadas en el protocolo.10.El participante ha recibido la vacuna del bacilo de Calmette-Guérin (BCG) durante el año anterior al comienzo del tratamiento del estudio.11.El participante que presenta:a.antecedentes de TB activa.b.indicios de TB, a menos que se apliquen los criterios definidos por el protocolo.12.El participante presenta cualquier infección micobacteriana no tuberculosa (MNT) actual o cualquier antecedente de infección MNT pulmonar en la visita de selección.13.El participante ha presentado indicios de inflamación ocular aguda, incluido uveítis anterior activa (es decir, un episodio agudo), durante las 4 semanas anteriores al comienzo del tratamiento del estudio.14.El participante presenta neoplasia maligna concurrente o antecedentes de neoplasia maligna durante los 5 años anteriores a la visita de selección, excepciones proporcionadas en el protocolo.15.El participante presenta fibromialgia, síntomas de artrosis o cualquier otro trastorno que, a criterio del investigador, podría interferir con las evaluaciones de la eficacia.16.El participante presenta la forma eritrodérmica, en gotas o pustulosa de la psoriasis o psoriasis medicamentosa.17.El participante presenta antecedentes de trastornos linfoproliferativos, incluido el linfoma, o signos y síntomas actuales que indican trastorno linfoproliferativo.18.El participante presenta inmunodeficiencias primarias, una esplenectomía anterior o trastornos inhibidores, incluidos los participantes que toman tratamiento inmunodepresor tras un trasplante de órgano.19.El participante se ha sometido a una cirugía mayor (también en las articulaciones) durante los 6 meses anteriores a la visita de selección, o tiene previsto someterse a una cirugía mayor durante el estudio.20.El participante tiene ideaciones suicidas activas o una conducta suicida positiva en la visita de selección, detectando cualquier antecedente de intento suicida (incluidos intentos actuales, intentos interrumpidos o intentos fracasados) o ideación suicida durante los últimos 6 meses.21.El participante presenta depresión moderadamente grave o grave, indicada por una puntuación ≥15 en la PHQ 9 que se ha llevado a cabo en la selección. Se permite que los participantes utilicen un medicamento para tratar la depresión, siempre que la dosis se ha mantenga estable durante las 4 semanas anteriores al comienzo del tratamiento del estudio. Los participantes que toman varios medicamentos para la depresión quedan excluidos del estudio.22.El participante presenta enfermedades concomitantes cardiovasculares graves, incluidos los antecedentes de infarto de miocardio, angina de pecho inestable, accidente cerebrovascular, insuficiencia cardiaca o hipertensión no controlada.23.El participante presenta anomalías de interés clínico en un ECG interpretado en un laboratorio central, que se ha realizado en la visita de selección. Ver resto criterios en versión inglesa o en protocolo. | |
E.5 End points |
E.5.1 | Primary end point(s) | Response rate of at least 50% improvement in the American College of Rheumatology (ACR50) response criteria at Week 12 compared with baseline. | Tasa de respuesta de una mejoría de al menos el 50 % según los criterios de respuesta del American College of Rheumatology (ACR50) en la semana 12 en comparación con el momento basal. | |
E.5.1.1 | Timepoint(s) of evaluation of this end point | From Baseline to week 12. | des del momento basal hasta la semana 12. | |
E.5.2 | Secondary end point(s) | 1. ACR20 response rate at Week 12 compared with baseline; 2. Psoriasis Area and Severity Index (PASI) 100 at Week 12 (in the subgroup of participants with psoriasis [PsO] involving at least 3% body surface area [BSA] at baseline). | 1.Tasa de respuesta ACR20 en la semana 12 en comparación con el momento basal. 2.Índice de gravedad y zona de psoriasis (PASI) 100 en la semana 12 (en el subgrupo de participantes con psoriasis que afecta a un mínimo del 3 % de la superficie corporal [SC] en el momento basal). | |
E.5.2.1 | Timepoint(s) of evaluation of this end point | From Baseline to week 12. | des del momento basal hasta la semana 12. | |
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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description | immunogenicity | inmunogenicidad | |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
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 | 5 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 51 |
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 | United States | Poland | Bulgaria | Spain | Czechia | Germany | Hungary | |
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 | LVLS | Ultima visita del ultimo participante | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |