The "EvolvE" Study
Research type
Research Study
Full title
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Barzolvolimab (CDX-0159) in Adults with Active Eosinophilic Esophagitis (The "EvolvE" Study)
IRAS ID
1006384
Contact name
Keryn Woodman
Contact email
Sponsor organisation
Celldex Therapeutics, Inc.
Eudract number
2022-001786-12
Research summary
Eosinophilic oesophagitis (EoE) is an allergic condition affecting the oesophagus - causing symptoms of oesophageal dysfunction (eg. food bolus obstruction, difficulty swallowing and chest pain), and inflammation in the oesophagus. EoE is the most common cause of food bolus obstruction in young adults with a rapidly increasing prevalence in the last 15 years. It can occur at any age but is commonly diagnosed in young adulthood.
Currently only one licensed treatment exists for this condition. Further treatment options are required for those either not tolerant or refractory to currently available therapy.
CDX0159-08 is a Phase 2 clinical trial funded by Celldex Therapeutics, Inc. It is a randomised, double-blind, placebo-controlled study, which means that participants may receive the study drug (CDX-0159), or they may receive a placebo drug. Both the study doctor and participant will not know what they have been assigned. This study will assess if CDX-0159 helps to reduce inflammation and other symptoms of EoE in adults.
This study aims to enrol approximately 60 participants, aged 18 and over, across 55 to 65 centres globally. The study consists of four phases (6-week Screening period, 16-week Placebo-controlled Treatment period, 12-week Active Treatment period, and 16-week Follow-up period) and will run for approximately 50 weeks per participant.
During the first (16-week) treatment phase, participants will have a 50/50 chance of receiving the active treatment or inactive placebo. During the second (12-week) treatment phase, all participants will receive active study drug.
The primary study objective is to evaluate the efficacy of CDX-0159 in reducing cells involved in inflammation with EoE. Additionally, difficulty swallowing (dysphagia) is characteristic of those with EoE which can have a detrimental impact on daily life. This study will explore the efficacy of CDX-0159 in reducing symptoms of dysphagia as well as exploring the safety profile of CDX-0159.REC name
Wales REC 1
REC reference
23/WA/0104
Date of REC Opinion
7 Sep 2023
REC opinion
Further Information Favourable Opinion