E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
moderate to severe Crohn’s Disease (CD), moderate to severe Ulcerative Colitis (UC) |
Enfermedad de Crohn de moderada a grave, colitis ulcerosa de moderada a grave |
|
E.1.1.1 | Medical condition in easily understood language |
Crohn’s Disease, Ulcerative Colitis |
Enfermedad de Crohn, colitis ulcerosa |
|
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 | 10017947 - Gastrointestinal disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10011401 |
E.1.2 | Term | Crohn's disease |
E.1.2 | System Organ Class | 10017947 - Gastrointestinal disorders |
|
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 assess the safety and tolerability of long-term use of BMS-986165 in participants with moderate to severe Crohn's Disease or with moderate to severe Ulcerative Colitis. |
Evaluar la seguridad y tolerabilidad del uso a largo plazo de BMS-986165 en pacientes con enfermedad de Crohn de moderada a grave o colitis ulcerosa de moderada a grave |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adults having previously completed Open-label extension treatment in 1 of the parent BMS-986165 CD or UC studies |
Adultos que hayan completado previamente el tratamiento abierto en uno de los ensayos originales de BMS-986165 de enfermedad de Crohn o colitis ulcerosa |
|
E.4 | Principal exclusion criteria |
Any disease or medical condition that, in the opinion of the investigator, would make the participant unsuitable for this study, would interfere with the interpretation of participant safety or study results, or is considered unsuitable by the investigator for any other reason |
Cualquier enfermedad o condición médica que, en opinión del investigador, haría que el paciente no fuera adecuado para este estudio, interferiría con la interpretación de la seguridad del participante o los resultados del estudio, o el investigador lo consideraría inadecuado por cualquier otra razón. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- Number and proportion of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEIs. - Number and proportion of participants experiencing abnormalities in laboratory testing, ECG, and vital sign parameters over time. - Changes from Day 1 for laboratory testing, ECG, and vital signs. |
- numero y proporción de pacientes que experimentan AAs AAGs, AAs que llevan una discontinuación del tratamiento y AA seleccionados. - número y proporción de pacientes que experimentan alteraciones de los parámetros de laboratorio, ECG y de las constantes vitales a lo largo del tiempo - Cambios desde el Día 1 de los parámetros de laboratorio, ECG y de las constantes vitales |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Approximately every 2 years |
Aproximadamente cada 2 años |
|
E.5.2 | Secondary end point(s) |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
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 |
Brazil |
Canada |
China |
Israel |
Japan |
Korea, Republic of |
Mexico |
Russian Federation |
Taiwan |
United States |
Belgium |
Czechia |
Denmark |
France |
Germany |
Hungary |
Ireland |
Italy |
Poland |
Portugal |
United Kingdom |
Netherlands |
Romania |
Spain |
Switzerland |
|
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 último paciente |
|
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 | 11 |
E.8.9.1 | In the Member State concerned days | 25 |
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 | 11 |
E.8.9.2 | In all countries concerned by the trial days | 18 |