A safety, tolerability, and PK study of Ent001 in patients with moderately to severely active UC
Research type
Research Study
Full title
A Phase Ib multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, preliminary pharmacodynamics, immunogenicity, and exploratory efficacy of Ent001 in adult patients with moderately to severely active ulcerative colitis.
IRAS ID
1009618
Contact name
Lisa Olson
Contact email
Sponsor organisation
Enthera S.r.l.
ISRCTN Number
ISRCTN93130126
Research summary
This trial is a Phase 1b multicentre, randomised, double blind, placebo-controlled study in \nadult males and females (of non-childbearing potential) patient(s) between the ages of 18 and 70 years. The Sponsor (Enthera S.r.l.) is developing the clinical trial medicine (Ent001) for treating active ulcerative colitis. Ulcerative colitis is a chronic inflammatory bowel disease, which is characterised by chronic relapsing and remitting inflammation of the colon, with persistent diarrhoea, abdominal pain, rectal bleeding, and weight loss. Ent001 is being developed with a new mechanism of action to help the gut lining to heal and work properly as a protective barrier and thus preventing the inflammatory processes that causes ulcerative colitis.\n\nThe main purpose of the clinical trial is to see how safe the clinical trial medicine is and how well it is tolerated after dosing. The clinical trial will also investigate how the body interacts with the administered clinical trial medicine. The clinical trial will also collect first data on the efficacy of this medicine in treating adult patients with moderately to severely active ulcerative colitis.\n\nThe clinical trial consists of 3 Screening Visits (up to 45 days in case of repeated analyses), 1 Treatment Period of 12 weeks and 1 Follow-up Period of another 12 weeks.\nPatient (s) will receive the treatment every 2 weeks between Day 1 (first dose) to Day 84 (last dose), in total 7 doses. For the first and the last dose patients might be required to stay in the Unit for 3 days and 2 nights and have assessments performed until 48 hours after dosing. All other visits will be for 1 day. \nThe total clinical trial duration for each patient including the Screening phase will be approximately 29 to 31 weeks.
REC name
London - Riverside Research Ethics Committee
REC reference
24/LO/0180
Date of REC Opinion
3 Apr 2024
REC opinion
Further Information Favourable Opinion