E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ulcerative Colitis |
Colitis Ulcerosa |
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E.1.1.1 | Medical condition in easily understood language |
A long-term (chronic) condition where the colon and rectum (large intestine or large bowel) become inflamed. |
Condiciones a largo plazo (crónico) en las que el colon y el recto (intestino grueso) está inflamado. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045365 |
E.1.2 | Term | Ulcerative colitis |
E.1.2 | System Organ Class | 100000004856 |
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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 characterize the efficacy, safety, and tolerability of ABBV-323 as induction treatment in subjects with moderately to severely active UC. |
Caracterizar la eficacia, seguridad y tolerabilidad de ABBV-323 como tratamiento de inducción en pacientes con Colitis Ulcerosa de moderada a severa. |
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E.2.2 | Secondary objectives of the trial |
1. To assess pharmacokinetics (PK) and receptor occupancy (RO) of ABBV-323 in subjects with moderately to severely active UC. 2. To characterize the efficacy, safety, and tolerability of ABBV-323 as maintenance therapy in subjects with clinical response to ABBV-323 following induction therapy. |
1. Evaluar la farmacocinética y la ocupación del receptor de ABBV-323 en pacientes con Colitis Ulcerosa de moderada a severa. 2. Caracterizar la eficacia, seguridad y tolerabilidad de ABBV-323 como terapia de mantenimiento en pacientes con respuesta clínica a ABBV-323 después de la terapia de inducción. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
·Subjects must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures. ·Adult male or female, between 18 and 75 years of age, inclusive, at time of the Baseline visit. ·Diagnosis of UC for at least 3 months prior to Baseline. Appropriate documentation of biopsy results consistent with the diagnosis of UC or in the assessment of the Investigator, must be available. ·Subject meets the following disease activity criteria: Active UC with an Adapted Mayo score of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central review). ·History of inadequate response, loss of response, or intolerance to one or more of the approved biologic therapies: infliximab, adalimumab, golimumab, vedolizumab, and/or tofacitinib (Note: If tofacitinib was received in a clinical trial, subject must have received open-label drug). ·Laboratory values that meet the following criteria: - Serum aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2 × upper limit of normal (ULN);Total white blood cell (WBC) count ≥ 3.0 × 10^9 /L; |
· Los pacientes deben firmar y fechar el consentimiento informado voluntariamente, aprobado por un comité ético (CEIm), antes de iniciar cualquier procedimiento de selección o específico del estudio. · Varones o Mujeres adultas entre 18 y 75 años, en el momento de la visita basal. · Diagnóstico de Colitis Ulcerosas desde al menos hace tres meses antes de la selección. Documentar apropiadamente los resultados de una biopsia con diagnóstico de colitis ulcerosa o evaluación del investigador, debe estar disponible. · Los pacientes deben reunir los siguientes criterios de actividad de la enfermedad: Colitis Ulcerosa Activa con Adapten Mayo de 5 a 9 puntos y una puntación sub-endoscópica de 2 a 3 confirmado por un revisor central. ·Historial de respuesta inadecuada, perdida de respuesta o intolerancia a una o más terapias biológicas: Infliximab, adalimumab, golimumab, vedolizumab, y/o tofacitinib (Nota: Si tofacitinib se recibió en ensayos clínicos, los pacientes deben haberlo reicibido en abierto) · Los valores de laboratorio deben reunir los siguientes criterios: - Aspartato transaminasa sérica (AST) y Alanina transaminada sérica (ALT) ≤ 2 × límite superior normal); El recuento total de células blancas sanguíneas ≥ 3.0 × 10^9 /L; |
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E.4 | Principal exclusion criteria |
- Subject must not have an active, chronic, or recurrent infection that based on the Investigator's clinical assessment makes the subject an unsuitable candidate for the study
- Subject must not have any malignancy except for successfully treated non metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
- Subject must not have history of dysplasia of the gastrointestinal tract or evidence of dysplasia in any biopsy performed during the Screening endoscopy |
- Los pacientes no tienen que tener infección activa, recurrente o crónica que en opinión de la evaluación clínica del investigador el paciente no sea un buen candidato para el estudio. - Los pacientes no tienen que tener ninguna malignidad excepto para los tratados con éxito en carcinoma metastásico de células cutáneas escamosas o carcinoma de células basales o carcinoma localizado in situ de cérvix. - Los pacientes no tienen que tener historial de displasia o evidendia de displasia gastrointestinal en alguna biopsia de la endoscopia en el screening. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of subjects with endoscopic improvement (Mayo endoscopic subscore of 0 or 1) at Week 8. |
La proporción de pacientes con mejora en la endoscopia (Subpuntación endoscópica de mayo de 0 o 1) en la semana 8 |
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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) |
Secondary Endpoints for Double-Blind Induction Period (Weeks 0 to 12): - Proportion of subjects with clinical remission per Adapted Mayo score at Week 8 - Proportion of subjects with clinical response per Adapted Mayo score at Week 8 - Proportion of subjects with clinical response per Partial Adapted Mayo score over time - Proportion of subjects with clinical remission per Full Mayo score at Week 8 in subjects with a Full Mayo score of 6 to 12 at Baseline. - Proportion of subjects with endoscopic remission at Week 8 |
Variables secundarias para doble ciego en el periodo de inducción (semanas 0 a 12): - Proporción de pacientes con remisión clínica por la puntuación de Adapted Mayo en la semana 8 - Proporción de pacientes con respuesta clínica por la puntuación de Adapted Mayo en la semana 8 - Proporción de pacientes con respuesta clínica pro Adapted Mayo a lo largo del tiempo - Proporción de pacientes con remisión clínica por puntuación de Full Mayo en la semana 8 en los pacientes con Full Mayo de 6 a 12 en el momento basal. - Proporción de pacientes con remisión en la endoscopia en la semana 8 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Time points provided in E.5.2 |
Puntos de tiempo en E.5.2 |
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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 | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 |
France |
Germany |
Italy |
Netherlands |
Spain |
United Kingdom |
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
|
84 days after the last subject last dose of study drug |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 24 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial days | 24 |