E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic Arthritis |
Artritis Psoriásica |
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E.1.1.1 | Medical condition in easily understood language |
Psoriatric Arthritis is an inflammatory disease where the immune system attacks healthy joints and skin causing pain, swelling, and stiffness in the joints, and red scaly patches on the skin. |
La AP es una enfermedad inflamatoria donde el sistema inmune ataca las articulaciones sanas y la piel causando dolor, hinchazón y rigidez en las articulaciones y parches escamosos rojos en la piel. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Skin and Connective Tissue Diseases [C17] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
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 |
Assess the safety and tolerability of risankizumab in PsA subjects who have completed all doses of study drug and the Week 24 visit in Study 1311.5. |
Evaluar la seguridad y la tolerabilidad de risankizumab en pacientes con artritis psoriásica (APs) que han recibido todas las dosis del fármaco del estudio y han completado la visita de la semana 24 del estudio 1311.5. |
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E.2.2 | Secondary objectives of the trial |
Assess efficacy of risankizumab, and the impact of risankizumab on the inhibition of structural progression, in PsA subjects who completed all doses of study drug and the Week 24 visit in Study 1311.5. |
Evaluar el efecto de risankizumab, y el impacto de risankizumab en la inhibición de la progresión estructural en pacientes con APs que han recibido todas las dosis del fármaco del estudio y han completado la visita de la semana 24 del estudio 1311.5. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects who have completed all doses of study drug and Week 24 visit of Study 1311.5.
2. Women of childbearing potential who are sexually active, must agree to use at least one accepted method of contraception throughout the study including 16 weeks after last dose of study drug is given. Accepted methods of contraception are as follows: ● combined (estrogen and progestogen containing) hormonal birth control (oral, intravaginal, transdermal) associated with inhibition of ovulation initiated at least 1 month prior to study participation ● progestogen-only hormonal birth control associated with inhibition of ovulation, initiated at least 1 month prior to study participation ● bilateral tubal occlusion/ligation ● intrauterine device (IUD) ● intrauterine hormone-releasing system (IUS). ● Subject must have only vasectomized sexual partner(s) ● True abstinence: Refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable).
Women of childbearing potential are defined as having experienced menarche and are: ● not postmenopausal (12 months with no menses without an alternative medical cause) and are ● not permanently sterilized (e.g., hysterectomy, bilateral oophorectomy or bilateral salpingectomy).
3. Females of childbearing potential must have a negative urine pregnancy test at Baseline (Week 0/V1). |
1. Pacientes que han recibido todas las dosis del fármaco del estudio y han completado la visita de la semana 24 del estudio 1311.5. 2. Las mujeres en edad fértil y sexualmente activas deben comprometerse a utilizar al menos un método anticonceptivo aceptado durante todo el estudio, y hasta un período de 16 semanas después de recibir la última dosis del fármaco del estudio. Los métodos aceptados de anticoncepción son los siguientes: ● Combinación de (que contengan estrógeno y progesterona) anticonceptivos hormonales (orales, intravaginal, transdérmica) asociados con la inhibición de la ovulación; iniciada al menos 1 mes antes de la participación en el estudio. ● Anticonceptivos hormonales sólo de progesterona, asociados con la inhibición de la ovulación, iniciados al menos 1 mes antes de la participación en el estudio. ● Oclusión/ligadura de trompas bilateral ● Dispositivo intrauterino (DIU) ● Sistema intrauterino liberador de hormonas (SIU). ● Los sujetos solo pueden tener parejas sexuales que se hayan realizado una vasectomía. ●Abstinencia real: Abstenerse de relaciones heterosexuales cuando este en línea con el estilo de vida habitual del sujeto (abstinencia periódica [por ejemplo, el calendario, la ovulación, sintotermal, métodos post-ovulación] y la retirada no son aceptables). Las mujeres en edad fértil se definen como aquellas que han experimentado la menarquia y son: ● No posmenopáusica (12 meses sin menstruación sin una causa médica alternativa) ● No esterilizadas de forma permanente (por ejemplo, la histerectomía, ooforectomía bilateral y salpingectomía bilateral). 3. Las mujeres en edad fértil deben aportar una prueba de embarazo negativa realizada en el momento basal (semana 0/V1). |
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E.4 | Principal exclusion criteria |
1. Female subject who is pregnant, breastfeeding or is considering becoming pregnant during study participation, including after the last dose of study drug is given. 2. Premature discontinuation of the treatment in Study 1311.5 for any reason. 3. Use of a biologic treatment other than risankizumab since first dose of study drug in Study 1311.5. 4. Time elapsed is > 8 weeks since the Week 24 visit in Study 1311.5 5. Active systemic infections during the last 2 weeks (exception: common cold) prior to randomization, as assessed by the investigator |
1. Mujeres embarazadas, en período de lactancia o que estén considerando quedarse embarazadas durante su participación en el estudio, incluido hasta la administración de la última dosis del fármaco del estudio. 2. Suspensión prematura del fármaco del estudio en el estudio 1311.5 por cualquier motivo. 3. Uso de un tratamiento biológico distinto de risankizumab desde la primera dosis del fármaco del estudio en el estudio 1311.5. 4. El tiempo transcurrido desde la visita de la semana 24 del estudio 1311.5 supera las 8 semanas. 5. Infecciones sistémicas activas durante las 2 últimas semanas (excepción: resfriado común) previas a la aleatorización, conforme a la evaluación del investigador. |
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E.5 End points |
E.5.1 | Primary end point(s) |
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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) |
● ACR 20 response compared to baseline (from study 1311.5) ● Change in mTSS compared to baseline (from study 1311.5) |
● Respuestas ACR 20 comparado con el momento basal (estudio 1311.5) ● Variación del índice total de Sharp modificado (ITSm) comparado con el momento basal (estudio 1311.5). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
● Weeks 24 and 48 ● Weeks 24 and 48 |
Semanas 24 y 48 Semanas 24 y 48 |
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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 | No |
E.6.12 | Pharmacoeconomic | No |
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) | 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 | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 34 |
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 |
Canada |
European Union |
Japan |
Taiwan |
United States |
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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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Date of the last subject's last visit, 16 weeks after the final dose of study drug. |
Fecha de la última visita del último sujeto, 16 semanas después de la última dosis del fármaco del estudio. |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 13 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 13 |