Age Range
16 - 80
Trial Purpose
Inhloso yale phrothokholi ukuhlola ukusebenza kahle nokuphepha kwe-tulisokibart kubahlanganyeli abanesifo sika-Crohn esisebenza ngokusesilinganisweni kuya esibi kakhulu. Imibono eyinhloko ye-Study 1 iwukuthi okungenani ileveli yomthamo we-tulisokibart engu-1 iphakeme kune-placebo engxenyeni yabahlanganyeli abazuza ukukhululwa emtholampilo ngokwesilinganiso se-Crohn’s Disease Activity Index (<150, US/FDA) noma imvamisa yesitulo kanye nesikolo sobuhlungu besisu (EU/EMA) kanye nengxenye yabahlanganyeli be-US / EMA-US kanye nempendulo ye-FDA5 kanye nempendulo ye-FDA5 EU/EMA), kanye nokuthi okungenani ileveli yomthamo we-tulisokibart engu-1 iphakeme kune-placebo engxenyeni yabahlanganyeli abazuza ukukhululwa emtholampilo ngokwesilinganiso se-Crohn’s Disease Activity Index (<150, US/FDA) noma imvamisa yesitulo ngasinye kanye nesikolo sobuhlungu besisu (EU/EMA) kanye nengxenye yabahlanganyeli abazuza impendulo ye-US/EMA1 ku-Endoscopic ye-US/EMA2 I-hypothesis eyinhloko ye-Study 2 iwukuthi okungenani ileveli yomthamo we-tulisokibart engu-1 iphakeme kune-placebo esilinganisweni sabahlanganyeli abazuza ukukhululwa emtholampilo ngokwesilinganiso se-Crohn’s Disease Activity Index (<150, US/FDA) noma imvamisa yokuquba kanye nesilinganiso sobuhlungu besisu (EU/EMA) kanye nengxenye yabahlanganyeli be-EU/EMA ekuphenduleni kwe-EU/e-EU kanye nokufeza i-EU/i-FDA1 ezuzayo e-EU/e-EU2.
NATIONAL TRIAL REFERENCE NUMBER
I-NCT06430801
EU CT Number
2023-508636-61-00
When speaking to your doctor or clinical trial representative, please have the trial reference number available.
About The Study
Trial Phase
Trial start and end dates
- Actual study start date Juni 5, 2024
- Estimated primary completion date Okthoba 30, 2028
- Estimated study completion date Novemba 12, 2029