RVT-3101 for the Treatment of Moderate to Severe Active Crohn’s Disease
Research type
Research Study
Full title
A Phase 2, Multicenter, Double-blind, Two-arm Study of Subcutaneous RVT-3101 for the Treatment of Subjects with Moderate to Severe Active Crohn’s Disease
IRAS ID
1008156
Contact name
Suzanne Vyvoda
Contact email
Sponsor organisation
Telavant Inc.
Eudract number
2023-504265-23
Clinicaltrials.gov Identifier
Research summary
Crohn’s Disease (CD) is a chronic disease that causes inflammation and can affect any part of the digestive tract (which runs from the mouth to anus), but usually affects the small intestine and the beginning of the large intestine. This study will test the investigational medication RVT-3101 for the treatment of moderate to severe active CD. RVT-3101 works by blocking a protein called tumor necrosis factor (TNF)-like ligand 1A (TL1A); this protein helps control inflammation and fibrosis (thickening/scarring of tissue). This study will try to find out if RVT-3101 can control moderate to severe active CD, if there are side effects and, if so, how serious they are and how the body takes it up, uses it and reacts to it. The study includes, up to 16wks initial treatment period (Part 1), followed by a 40wks Follow-on Treatment period (Part 2) and a Safety Follow-up Period after study treatment is completed. Each participant will be in the study for approximately 70 wks. About 105 participants aged 18 to 75 years, with a confirmed diagnosis of moderate to severe CD and at least 1 previous treatment that was not successful, will be enrolled in the study. RVT-3101 may have side effects that are not known yet and that cannot be predicted, including ones that are life-threatening or fatal. Participants will be required to attend clinic visits were study procedures will be performed. Participants will be monitored throughout the study, participation is voluntary and they will be required to sign the Informed Consent Form before any study procedures can be started.
REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0842
Date of REC Opinion
10 Jan 2024
REC opinion
Further Information Unfavourable Opinion