A Phase Ib/IIb, randomised, double-blind, placebo-controlled trial to investigate the safety, tolerability and clinical activity of humanised antibody GSK1070806 in the treatment of patients with moderate-to-severe Crohn's disease

niversity of Birmingham0 sites5 target enrollmentOctober 28, 2019

Overview

No summary available.

Registry

who.int

Start Date

October 28, 2019

End Date

June 1, 2020

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

•A patient will be eligible for inclusion in this study only if all of the following criteria apply:
•1\. Written informed consent prior to any of the screening procedures including discontinuation of prohibited medications. (see Section 7\.11 for additional information)
•2\. Patients that have been diagnosed with moderate to severe Crohn’s disease for at least 3 months prior to Screening Visit 1 defined by CDAI score between 220\-450
•3\. Patients are required to have endoscopic evidence of active Crohn’s disease at Baseline (screening visit 1\) defined by endoscopic appearance: SES\-CD excluding the narrowed component of \> \= 6 (or \> \= 4 for patients with isolated ileal disease).
•4\. AST and ALT \< \= 2xULN; alkaline phosphatase and bilirubin \< \= 1\.5xULN (isolated bilirubin \> 1\.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \< 35%)
•5\. Male or female participants aged \> \= 16 years (up to 80 years)
•Male participants:
•6\. A male participant must agree to use contraception as detailed in Appendix 5 of this protocol for at least 180 days post\-dose of study medication and refrain from donating sperm during this period.
•Female participants:
•7\. A female participant is eligible to participate if she is not pregnant or breastfeeding and not a woman of childbearing potential (WOCBP) defined as at least one of the following conditions:

•A participant will not be eligible for inclusion in this trial if any of the following criteria apply:
•1\. Diagnosis of ulcerative or indeterminate colitis
•Crohn’s Disease complications:
•2\. Evidence of an infected abscess by MRI or other examinations
•3\. Bowel surgery other than appendectomy within 12 weeks prior to screen and/or has planned surgery or deemed likely to need surgery for CD during the trial period
•4\. Participants with ileostomies, colostomies or rectal pouches
•5\. Participants with a bowel stricture that is fixed
•6\. Participants with evidence of short bowel syndrome
•7\. Participants requiring enteral or parenteral feeding
•8\. Deep penetrating ulcers at endoscopy thought to be at risk for perforation