E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Atopic dermatitis |
Dermatitis atópica |
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E.1.1.1 | Medical condition in easily understood language |
Atopic dermatitis (AD) or eczema is a common inflammatory skin disease characterized by dry skin, red and crusting rash and intense pruritus (itch) that may affect people of all ages. |
Dermatitis atópica o eccema: enfermedad cutánea inflamatoria común caracterizada por piel seca, erupción enrojecida, con costras y picazón intenso que puede afectar a personas de todas las edades. |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003639 |
E.1.2 | Term | Atopic dermatitis |
E.1.2 | System Organ Class | 100000004858 |
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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 |
The objective of this study is to assess the long-term safety and efficacy of lebrikizumab in patients with moderate-to-severe AD. |
El objetivo de este estudio es evaluar la seguridad y eficacia a largo plazo de lebrikizumab en pacientes con DA de moderada a grave. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Received treatment in a Dermira -or Lilly- sponsored lebrikizumab study, DRM06-AD04, DRM06-AD05, DRM06-AD06, DRM06-AD17 or DRM06-AD18 (parent trial) and have adequately completed the study treatments and last patient visit of the parent trial. 2. Willing and able to comply with all clinic visits and study-related procedures. 3. For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo. NOTE: A woman of childbearing potential (WOCBP) is defined as a postmenarcheal female, who has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause) and has not undergone surgical sterilization (removal of ovaries and/or uterus). NOTE: The following are highly effective contraceptive methods: combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal) associated with inhibition of ovulation, progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, intrauterine device (IUD), bilatural tubal, intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner, or sexual abstinence. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception. If the highly effective contraceptive methods are contraindicated or strictly declined by the patient, acceptable birth control methods may be considered. These may include a combination of the following methods: • male or female condom with spermicide and • cap, diaphragm, or sponge with spermicide. 4. Male patients are not required to use any contraception except in compliance with specific local government study requirements. 5. Provide signed informed consent/assent as described in Section 10.2. |
1. Recibió el tratamiento en un estudio de lebrikizumab patrocinado por Dermira (o Lilly), DRM06-AD04, DRM06-AD05, DRM06-AD06, DRM06-AD17 o DRM06-AD18 (ensayo principal) y completó adecuadamente los tratamientos del estudio y la última visita del paciente del ensayo principal. 2. Disposición para acudir a todas las visitas y realizar los procedimientos del estudio. 3. Para mujeres en edad fértil: deben aceptar no mantener relaciones sexuales con hombres o emplear un método anticonceptivo de alta eficacia durante el tratamiento y, al menos, durante las 18 semanas siguientes tras recibir la última dosis de lebrikizumab o placebo. NOTA: Una mujer en edad fértil (MEF) se define como una mujer posmenárquica, que no ha alcanzado el periodo posmenopaúsico (12 meses continuos de amenorrea sin causa identificada diferente a la menopausia) y no se ha sometido a una esterilización quirúrgica (extracción de los ovarios y/o el útero). NOTA: Los siguientes son métodos anticonceptivos de alta eficacia: método anticonceptivo hormonal (oral, intravaginal, transdérmico) combinado (contiene estrógeno y progestágeno) asociado con la inhibición de la ovulación, método anticonceptivo hormonal de progestágeno solo (oral, inyectable, implantable) asociado con la inhibición de la ovulación, dispositivo intrauterino (DIU), tubárica bilateral, sistema intrauterino de liberación de hormonas (SIU), oclusión de trompas bilateral, ligadura de trompas bilateral, pareja sometida a vasectomía o abstinencia sexual. La fiabilidad de la abstinencia sexual se debe evaluar en relación con la duración del ensayo clínico y el estilo de vida habitual y deseado de la paciente. La abstinencia periódica (p. ej., calendario, ovulación o métodos sintotérmico o posovulación) y la marcha atrás no constituyen métodos anticonceptivos válidos. Si los métodos anticonceptivos altamente efectivos están contraindicados o estrictamente rechazados por la paciente, se pueden considerar métodos anticonceptivos aceptables. Estos pueden incluir una combinación de los siguientes métodos: • condón masculino o femenino con espermicida y • gorro, diafragma o esponja con espermicida. 4. Los pacientes varones no están obligados a utilizar ningún método anticonceptivo excepto en cumplimiento de los requisitos específicos del estudio del gobierno local. 5. Proporcionar el consentimiento informado firmado, tal y como se describe en la Sección 10.2 |
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E.4 | Principal exclusion criteria |
1. Patients who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to lebrikizumab, which in the opinion of the investigator or Study Protocol: DRM06-AD07 Lebrikizumab of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the patient. 2. Patients who, during their participation in the parent trial, developed an AE that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the patient. 3. Conditions in the previous parent study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to lebrikizumab or led to investigator - or sponsor-initiated withdrawal of patient from the study (e.g., noncompliance, inability to complete study assessments, etc.). 4. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study. * Note for exclusion criteria # 1, 2, and 3: In studies that are still blinded, conditions deemed related to the study treatment will be considered related to lebrikizumab. |
1. Pacientes que, durante su participación en el ensayo principal, desarrollaron un acontecimiento adverso grave (AAG) que se consideró que estuvo relacionado con lebrikizumab, lo que, en opinión del investigador o del supervisor médico, podría indicar que la continuación del tratamiento con lebrikizumab puede presentar un riesgo no razonable para el paciente.* 2. Pacientes que, durante su participación en el ensayo principal, desarrollaron un AA que se consideró que estuvo relacionado con lebrikizumab y provocó el abandono del tratamiento del estudio, lo que en opinión del investigador o del supervisor médico podría indicar que la continuación del tratamiento con lebrikizumab puede presentar un riesgo no razonable para el paciente.* 3. Afecciones en el estudio principal anterior coherentes con los criterios definidos por el protocolo para la interrupción permanente de la administración del fármaco del estudio, si se considera que están relacionadas con lebrikizumab o provocaron la retirada del estudio, iniciada por el investigador o el promotor (por ej., incumplimiento, incapacidad para completar las evaluaciones del estudio, etc.).* 4. Mujeres embarazadas o en periodo de lactancia, o que tengan planeado quedar embarazadas o dar el pecho, durante el estudio. * Nota para los criterios de exclusión n.º 1, 2 y 3: En los estudios que aún son ciegos, las afecciones que se considere que están relacionadas con el tratamiento del estudio se considerará que están relacionadas con lebrikizumab. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Describe the proportion of patients discontinued from study treatment due to adverse events through the last treatment visit. |
Describa la proporción de pacientes que abandonaron el tratamiento del estudio debido a eventos adversos hasta la última visita de tratamiento. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Through the last treatment visit |
Hasta la última visita de tratamiento |
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E.5.2 | Secondary end point(s) |
• Proportion of patients with a response of IGA 0 or 1 • Proportion of patients achieving response of EASI-75 from baseline of parent study. |
• Proporción de pacientes con una respuesta de IGA 0 o 1 • Proporción de pacientes que lograron una respuesta de EASI-75 desde el inicio del estudio principal. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Over the duration of the study |
Durante la duración del estudio |
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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 | 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 |
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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 | 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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 131 |
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 |
Australia |
Canada |
Korea, Republic of |
Mexico |
Singapore |
Taiwan |
Ukraine |
United States |
Bulgaria |
Estonia |
France |
Germany |
Latvia |
Lithuania |
Poland |
Spain |
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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
|
The end of the study is defined as the date of the last visit of the last patient in the study shown in the Schedule of Visits and Procedures |
El final del estudio se define como la fecha de la última visita del último paciente del estudio que se muestra en el Programa de visitas y procedimientos. |
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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 | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |