CROSSING
Research type
Research Study
Full title
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Patients with Eosinophilic Esophagitis (CROSSING)
IRAS ID
1008134
Contact name
Manika Azad
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2022-001294-31
Research summary
CROSSING study is designed to learn more about a biologic drug called tezepelumab and to know if it could be an effective and safe treatment for eosinophilic esophagitis (EoE) in patients aged 12 to 80 years old.
Tezepelumab is approved by the US Food and Drug Administration (FDA) and also in other countries as a treatment for adults and adolescents with severe asthma. Tezepelumab is not approved for EoE by any health authority, except for use in research studies.
In the oesophagus of people suffering from EoE there can be an elevated level of white blood cells called eosinophils that are involved in the inflammation of the oesophagus. A protein made by the body, called thymic stromal lymphopoietin (TSLP), appears to play a major role in causing this inflammation. Tezepelumab is an antibody that has been made to block the effects of TSLP. Tezepelumab may help decrease inflammation of the oesophagus in people with EoE and improve difficulties in swallowing.
About 360 people (in study sites located in approximately 20 countries) will take part in CROSSING study to investigate tezepelumab for the treatment of EoE.
The dose of tezepelumab required in EoE is unknown, therefore this study will compare two doses of tezepelumab every 4 weeks to a placebo. The study groups are assigned in a 1:1:1 ratio for one year, followed by an active treatment extension period of six months where all participants will be given active study drug.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
23/LO/0555
Date of REC Opinion
22 Dec 2023
REC opinion
Further Information Favourable Opinion