Trial Profile
A Phase I, Open-Label, Randomized, Pharmacokinetic, Pharmacodynamic, And Safety Study Of Etrolizumab Followed By Open-Label Extension And Safety Monitoring In Pediatric Patients From 4 Years To Less Than 18 Years Of Age With Moderate To Severe Ulcerative Colitis Or Moderate To Severe Crohn's Disease
Status:
Discontinued
Phase of Trial:
Phase I
Latest Information Update: 04 Dec 2023
Price :
$35
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At a glance
- Drugs Etrolizumab (Primary)
- Indications Crohn's disease; Ulcerative colitis
- Focus Pharmacodynamics; Pharmacokinetics
- Acronyms FENNEL
- Sponsors Roche
- 01 Nov 2023 Status changed from active, no longer recruiting to discontinued due to program discontinuation, based on mixed efficacy results in the adult ulcerative colitis and Crohn's disease studies. There were no safety concerns.
- 05 Oct 2023 This trial has been discontinued in Spain, according to the European Clinical Trials Database record.
- 01 Oct 2023 This trial has been discontinued in Belgium.