Efficacy and Safety of Rosnilimab in Subjects with Ulcerative Colitis
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab in Subjects with Moderate to Severe Ulcerative Colitis
IRAS ID
1008840
Contact name
Gerlee Thomas
Contact email
Sponsor organisation
AnaptysBio, Inc.
Research summary
This study will test an experimental drug called rosnilimab for the potential treatment of Ulcerative Colitis (UC). Rosnilimab is a new treatment under investigation for people with UC who didn't feel better with prior treatments. Subjects will have a 1 in 3 chance (33%) to be assigned to receive rosnilimab low dose or high dose separately, and 1 in 3 chance (33%) to be assigned to receive a placebo (looks like the study drug but has no actual therapeutic effect). So subjects will have a 2 in 3 chance (66%) to receive rosnilimab. This is a “blinded” study meaning that neither the study Sponsor, the study doctor, the participant, or the study staff will know which type of study drug treatment the participant is receiving. The study drug will be given to the participant via subcutaneous injections (by needle under into the skin). Maximum participation in this study is 39 weeks and will consist of a Screening Period, Treatment Period and Safety Follow-up Period (3 more clinic visits). The Treatment Period in the study will be divided in two parts: First treatment period: Rosnilimab or Placebo (Up to 12 weeks). Secondary Study Treatment Assignment (Up to Week 24). At week 12, an assessment will be done to measure how the subject has done on the study so far. Based on the outcome, if the subject received placebo and has not responded, then they will begin a 12-week period of receiving rosnilimab study drug. The rest of the subjects will continue during the 12-week period of receiving study drug or placebo as they did in their first 12 weeks of study participation. The trial is planned to run in 3 hospitals in the UK and a further 95 hospitals around the world. Study assessments will include endoscopies and colon biopsies, blood and urine samples, physical examinations and a chest X-ray/CT scan.
REC name
London - Fulham Research Ethics Committee
REC reference
23/LO/0999
Date of REC Opinion
26 Jan 2024
REC opinion
Further Information Favourable Opinion