Injongo yocwaningo

Inhloso yale phrothokholi ukuhlola ukusebenza kahle nokuphepha kwe-tulisokibart kubabambiqhaza abanesifo sika-Crohn esisebenza esimweni esimaphakathi kuya kwesibucayi. Imibono eyinhloko Yocwaningo 1 iwukuthi okungenani ileveli yomthamo we-tulisokibart engu-1 iphakeme kunomuthi-mbumbulu engxenyeni yababambiqhaza abazuza ukumisa ukwelashwa ngokwesilinganiso se-Crohn’s Disease Activity Index (<150, US/FDA) noma imvamisa yendle kanye nomphumela wobuhlungu besisu (EU/EMA) kanye nengxenye yababambiqhaza abafinyelela umphumela we-endoscopic Evikini-52 (US/FDA and EU/EMA), nokuthi okungenani ileveli yomthamo we-tulisokibart engu-1 iphakeme kunomuthi-mbumbulu engxenyeni yababambiqhaza abazuza ukumisa ukwelashwa ngokwesilinganiso se-Crohn’s Disease Activity Index (<150, US/FDA) noma imvamisa yendle ngayinye kanye nomphumela wobuhlungu besisu (EU/EMA) kanye nengxenye yababambiqhaza abafinyelela umphumela we-endoscopic Evikini 12 (US/FDA kanye ne-EU/EMA). I-hypothesis eyinhloko Yocwaningo 2 iwukuthi okungenani ileveli yomthamo we-tulisokibart engu-1 iphakeme kunomuthi-mbumbulu esilinganisweni sabahlanganyeli abazuza ukumisa ukwelashwa ngokwesilinganiso se-Crohn’s Disease Activity Index (<150, US/FDA) noma imvamisa yendle kanye nesilinganiso sobuhlungu besisu (EU/EMA) kanye nengxenye yababambiqhaza abafinyelela umphumela we-endoscopic Evikini 12 (US/FDA kanye ne-EU/EMA).

Isihlonzi se- Clinicaltrials.gov

I-NCT06430801

I-EU CT

2023-508636-61-00

Lapho uxoxa nodokotela wakho noma ilungu leqembu locwaningo lwezokwelapha, sicela ube nenombolo yereferensi yocwaningo noma inombolo ye-EudraCT.

Izinsiza

Ukufaneleka

Uchwepheshe wezempilo uyena kuphela onganquma ukuthi uyafaneleka yini ukubamba iqhaza ocwaningweni lwezokwelapha. Nokho, lolu lwazi lungaba usizo ekuqaleni ingxoxo nodokotela wakho.

Izimo Icon

Izimo

Isifo Sikacrohn

Ububanzi Bobudala Icon

Ububanzi Bobudala

16 - 80

Ubulili Icon

Ubulili

Owesilisa/Insikazi

Trial phase Icon Isigaba socwaningo esiqhubekayo

Isigaba ISIGABA3 Socwaningo

Ezingcwaningweni Zesigaba 3, abacwaningi bazama ukuthola ukuthi umuthi ungasebenza yini enanini elikhulu labantu, ngokuvamile ababambiqhaza abayi-1,000 ukuya ku-5,000 abanesimo sempilo esizokwelashwa umuthi. Ezingcwaningweni zomgomo, ababambiqhaza bangaba abanempilo noma abanezifo noma izimo ezithile. Ucwaningo lwesigaba 3 lungenziwa ehhovisi likadokotela, emtholampilo, noma esibhedlela.

Trial start Icon Izinsuku zokuqala nokuqedwa kocwaningo
  • Usuku lokuqala kocwaningo Juni 5, 2024
  • Usuku oluyinhloko lokuqeda olulinganiselwe Okthoba 30, 2028
  • Usuku lokuqeda ucwaningo olulinganiselwe Novemba 12, 2029

Izindawo zocwaningo

Izindawo ezibonisiwe kungenzeka zishintshile kwezinye izimo. Sicela ushayele inombolo esohlwini lwemiphumela yendawo ukuqinisekisa isikhungo socwaningo esiseduze. Xoxa nelungu lesikhungo socwaningo ukuthola ulwazi olwengeziwe.

Yikuphi ongakwenza ngokulandelayo?

Uma ucabanga ukuthi lolucwaningo lwezokwelapha lungakulungela futhi unesithakazela sokubamba iqhaza, ukuthatha isinyathelo esilandelayo ukuze ubone ukuthi uyafaneleka yini.

Xoxa nodokotela wakho noma iqembu lokunakekela

Phrintha leli khasi elinemininingwane yocwaningo noma ulithumele nge-imeyili kudokotela wakho ukuxoxa ngocwaningo lwezokwelapha ekuvakasheni okulandelayo.

Thola usizo ngokuxoxa nodokotela wakho noma iqembu lokunakekela

Isihlonzi se- Clinicaltrials.gov

I-NCT06430801

I-EU CT

2023-508636-61-00

Lapho uxoxa nodokotela wakho noma ilungu leqembu locwaningo lwezokwelapha, sicela ube nenombolo yereferensi yocwaningo noma inombolo ye-EudraCT.

Ukubamba iqhaza ocwaningweni lwezokwelapha kuyisinqumo esibalulekile

Uma ucabangela ukujoyina ucwaningo lwezokwelapha, qala ngokufunda okuningi ngokunokwenzeka ngalo:

  • Umuthi wophenyo ocwaningwayo
  • Yiziphi izingozi noma izinzuzo ezingaba khona zababambiqhaza

Xoxa nodokotela wakho ngocwaningo lwezokwelapha ungakenzi isinqumo sokujoyina.

Funda ikhasi elithi “Ongakucabangela” ukuthola imibuzo eyengeziwe ongayibuza nongacabanga ngayo