E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderately to Severely Active Ulcerative Colitis |
Colitis ulcerosa activa de grado moderado o severo |
|
E.1.1.1 | Medical condition in easily understood language |
Inflammatory bowel disease (IBD) |
Enfermedad inflamatoria intestinal (EII) |
|
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 | 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 |
|
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 JNJ-78934804 at Week 48 compared with each monotherapy (guselkumab alone and golimumab alone) |
Evaluar la eficacia de JNJ-78934804 en la semana 48 frente a cada producto en monoterapia (guselkumab solo y golimumab solo) |
|
E.2.2 | Secondary objectives of the trial |
1 To evaluate the efficacy of JNJ-78934804 compared with each monotherapy across a range of outcome measures 2 To evaluate the efficacy of JNJ-78934804 at Week 24 compared with placebo 3 To evaluate the safety of JNJ-78934804 compared with each monotherapy and placebo 4 To evaluate the pharmacokinetics (PK) and immunogenicity of JNJ-78934804 compared with each monotherapy |
1. Evaluar la eficacia de JNJ-78934804 frente a cada producto en monoterapia en cuanto a diversos resultados 2. Evaluar la eficacia de JNJ-78934804 en la semana 24 frente al placebo 3. Evaluar la seguridad de JNJ-78934804 frente a cada producto en monoterapia y frente al placebo 4. Evaluar la farmacocinética (pharmacokinetics, PK) y la inmunogenia de JNJ-78934804 frente a cada producto en monoterapia |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Confirmed diagnosis of ulcerative colitis (UC) for at least 3 months prior to baseline •Moderately to severely active UC as assessed by the modified mayo score •Demonstrated inadequate response, loss of response, or intolerance to at least one biologic or novel oral with biologic-like activity •If female and of childbearing potential, must meet the contraception and reproduction requirements
For an overview of all the inclusion criteria please refer to protocol section 5.1 |
- Diagnosis confirmada de colitis ulcerosa (CU) durante al menos 3 meses antes de la referencia. - CU activa de moderada a severa determinada por la escala Mayo modificada. - Respuesta inadecuada demostrada, perdida de respuesta o intolerancia a al menos un tratamiento biológico o tratamiento oral novedoso con actividad similar a la de un biológico. - Si el paciente es mujer y con potencial de concebir, debe cumplir los requerimientos de reproducción y de anticoncepción.
Para un resumen de todos los criterios de inclusión, refiérase a la sección 5.1 del protocolo. |
|
E.4 | Principal exclusion criteria |
•Has severe extensive colitis as defined in the protocol •Extent of inflammatory disease limited to the rectum •Participants with current diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, or crohn's disease (CD) •Has a history of, or ongoing, chronic or recurrent infectious disease •Currently has a malignancy or a history of malignancy within 5 years before screening (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ that has been treated with no evidence of recurrence within 12 months of first dose of study intervention)
For an overview of all the exclusion criteria please refer to protocol section 5.2 |
- Tiene colitis extensiva severa como se define en el protocolo. - La extensión de la enfermedad inflamatoria de limita al recto. - Pacientes con una diagnosis actual de colitis indeterminada, colitis microscópica, colitis isquémica o enfermedad de Crohn (EC). - Tiene un historial de, o padece actualmente, una enfermedad infecciosa crónica o recurrente. - Actualmente tiene un tumor maligno o un historial de tumor/es maligno/s en los 5 años previos a la selección (con la excepción de cáncer de piel no melanoma o carcinoma de cuello uterino in situ que haya sido tratado sin evidencia de recurrencia dentro de los 12 meses posteriores a la primera dosis de la intervención del estudio)
Para un resumen de todos los criterios de inclusión, refiérase a la sección 5.2 del protocolo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Clinical remission at Week 48 |
Remisión clínica en la semana 48 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At Week 48 |
En la semana 48 |
|
E.5.2 | Secondary end point(s) |
1 Combination of histological remission and endoscopic improvement 2 Clinical remission of JNJ-78934804 at Week 24 compared with placebo 3 Frequency and type of AEs, serious adverse events (SAEs) 4 Serum concentrations of guselkumab and golimumab over time 5 Incidence and titers of antibodies to guselkumab and golimumab 6 Incidence of neutralizing antibodies to guselkumab and golimumab |
1. Combinación de remisión histológica y mejora endoscópica 2. Remisión clínica de JNJ-78934804 en la semana 24 comparada con placebo 3. Frecuencia y tipo de acontecimientos adversos (adverse events, AE) y acontecimientos adversos graves (serious adverse events, SAE) 4. Concentraciones séricas de guselkumab y golimumab a lo largo del tiempo 5. Incidencia y títulos de anticuerpos contra el guselkumab y golimumab 6. Incidencia de anticuerpos neutralizantes contra el guselkumab y golimumab |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 - At Week 48 2 - At Week 24 |
1- En la semana 48 2- En la semana 24 |
|
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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Guselkumab y Golimumab (Monoterapia) |
Guselkumab and Golimumab (Monotherapy) |
|
E.8.2.4 | Number of treatment arms in the trial | 6 |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 115 |
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 |
Argentina |
Australia |
Brazil |
Canada |
Chile |
China |
Egypt |
Hong Kong |
India |
Israel |
Japan |
Jordan |
Korea, Republic of |
Malaysia |
Mexico |
New Zealand |
Taiwan |
United States |
Austria |
Estonia |
Finland |
France |
Latvia |
Lithuania |
Poland |
Sweden |
Bulgaria |
Netherlands |
Spain |
Switzerland |
Czechia |
Germany |
Greece |
Italy |
Belgium |
Bosnia and Herzegovina |
Croatia |
Denmark |
Georgia |
Hungary |
Ireland |
Norway |
Portugal |
Russian Federation |
Slovakia |
Slovenia |
Turkey |
Ukraine |
United Kingdom |
Serbia |
|
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 study is considered as the last scheduled study assessment shown in the SoA ( Schedule of activities) for the last participant or if a decision has been made by the sponsor not to pursue an indication in UC and appropriate follow-up has been completed. |
Se considerará que se ha alcanzado el fin del estudio cuando el último participante se haya sometido a la última evaluación programada del estudio que se muestra en el Calendario de actividades (Schedule of activities, SoA) o si el promotor toma la decisión de no proseguir el desarrollo en la indicación de CU y se ha completado el seguimiento |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |