Trial Profile
A phase III study of Cobitolimod for the treatment of ulcerative colitis: Induction study 2
Status:
Planning
Phase of Trial:
Phase III
Latest Information Update: 06 Mar 2023
Price :
$35
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At a glance
- Drugs Cobitolimod (Primary)
- Indications Ulcerative colitis
- Focus Registrational; Therapeutic Use
- Sponsors InDex Pharmaceuticals
- 27 Feb 2023 According to an InDex Pharmaceutical media release, the company will attend the annual congress of the European Crohn's and Colitis Organisation (ECCO) to provide information about cobitolimod and the ongoing phase III program CONCLUDE. InDex's team member will take the opportunity to meet Investigators of Induction 1 study of the CONCLUDE program to discuss study progress with the coordinating Investigator Professor Raja Atreya.
- 16 Aug 2022 According to an InDex Pharmaceuticals media release, the PMDA stated overall acceptance for the non-clinical package as well as the study design of the phase III program. Pharmacokinetic data for cobitolimod in Japanese patients will have to be collected prior to applying for market approval, but can be conducted during the remaining phase III program.
- 16 Aug 2022 According to an InDex Pharmaceuticals media release, the company has received positive feedback from the Japanese regulatory authority, the Pharmaceuticals and Medical Devices Agency (PMDA), regarding the clinical development plan for a future marketing authorization application for cobitolimod. The PMDA has accepted enrolment of Japanese ulcerative colitis patients in this trial, without performing specific Japanese studies prior to study start.