E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderately to Severely Active Ulcerative Colitis |
Colite ulcerosa attiva da moderata a grave |
|
E.1.1.1 | Medical condition in easily understood language |
Inflammatory bowel disease (IBD) |
Malattia infiammatoria intestinale (IBD) |
|
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). |
Valutare l’efficacia di JNJ-78934804 alla Settimana 48 rispetto a ciascuna monoterapia (guselkumab in monoterapia e golimumab in monoterapia). |
|
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 Valutare l’efficacia di JNJ-78934804 rispetto a ciascuna monoterapia mediante una serie di misure di esito. 2 Valutare l’efficacia di JNJ-78934804 alla Settimana 24 rispetto al placebo. 3 Valutare la sicurezza di JNJ-78934804 rispetto a ciascuna monoterapia e placebo. 4 Valutare la farmacocinetica (PK) e l’immunogenicità di JNJ-78934804 rispetto a ciascuna 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. |
• Diagnosi confermata di colite ulcerosa (CU) da almeno 3 mesi prima del basale. • CU attiva da moderata a grave valutata mediante il punteggio Mayo modificato. • Risposta inadeguata dimostrata, perdita di risposta o intolleranza ad almeno un farmaco biologico o nuovo farmaco orale con attività biologica. • Se di sesso femminile e in età fertile, deve soddisfare i requisiti di contraccezione e riproduzione. Per una panoramica di tutti i criteri di inclusione, si prega di far riferimento alla sezione 5.1 del protocollo. |
|
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. |
• Presenza di colite estesa grave, come definita nel protocollo. • Estensione della malattia infiammatoria limitata al retto. • Partecipanti con diagnosi attuale di colite indeterminata, colite microscopica, colite ischemica o Malattia di Crohn (MC). • Anamnesi o presenza di malattia infettiva cronica o ricorrente in corso. • Presenta attualmente un tumore maligno o un’anamnesi di tumore maligno nei 5 anni precedenti lo screening (ad eccezione del tumore della pelle non melanoma o del carcinoma cervicale in situ che è stato trattato senza alcuna evidenza di recidiva nei 12 mesi. precedenti la prima dose del trattamento dello studio). Per una panoramica di tutti i criteri di esclusione, si faccia riferimento alla sezione 5.2 del protocollo. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Clinical remission at Week 48 |
Remissione clinica alla Settimana 48 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At Week 48 |
Alla settimana 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 Combinazione di remissione istologica e miglioramento endoscopico. 2 Remissione clinica di JNJ-78934804 alla Settimana 24 rispetto al placebo. 3 Frequenza e tipo di EA ed eventi avversi seri (SAE). 4 Concentrazioni sieriche di guselkumab e golimumab nel tempo. 5 Incidenza e titoli degli anticorpi anti-guselkumab e anti-golimumab. 6 Incidenza di anticorpi neutralizzanti anti-guselkumab e anti-golimumab. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 - At Week 48 2 - At Week 24 |
1- Alla Setttimana 48 2- Alla Setttimana 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 |
Immunogeniticità |
|
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 | Yes |
E.8.1.7.1 | Other trial design description |
Guselkumab and Golimumab (Monoterapia) |
Guselkumab and Golimumab (Monotherapy) |
|
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 | 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 | 14 |
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 | Information not present in EudraCT |
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. |
La fine dello studio sarà considerata come l’ultima valutazione dello studio programmata indicata nel calendario delle attività (SoA) dell’ultimo partecipante o se lo sponsor decide di non perseguire un’indicazione per la CU e se il follow-up appropriato è stato completato. |
|
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 |