A Study to Investigate the Efficacy and Safety of Solrikitug in Adults with Eosinophilic Esophagitis
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study with an Open-Label Extension to Investigate the Efficacy and Safety of Solrikitug in Adults with Eosinophilic Esophagitis (ALAMERE)
IRAS ID
1010418
Contact name
Jiten Rana
Contact email
Sponsor organisation
NI One Inc. (doing business as “Uniquity One”)
Clinicaltrials.gov Identifier
Research summary
Solrikitug is an investigational drug for the treatment of Eosinophilic Esophagitis (EoE), an inflammatory disease caused by eosinophils (white blood cells) releasing substances, which causes inflammation and results in symptoms of oesophageal dysfunction and poor quality of life. Human thymic stromal lymphopoietin (TSLP) is the protein that drives the inflammatory process in EoE. Solrikitug is a highly selective antibody (protein of the immune system that helps fight infections) that binds to human TSLP. Solrikitug is designed to stop TSLP from causing eosinophils to build up in the oesophagus. This decreases the inflammation and could thereby also decrease the symptoms of EoE. The goal of the study is to see if the study medication can help reduce the number of eosinophils in the oesophagus and ease the symptoms associated with EoE.
Researchers will test the effectiveness and safety of the Solrikitug in patients with EoE. To be eligible for this study participants must have confirmed documented diagnosis of EoE. The study population will be males or females, aged 18 to 75 years.
The study consists of screening period, treatment period, open-label treatment period and safety follow up. The overall duration of this study is 72 weeks. Researchers will compare the effects of solrikitug to a placebo. There will be 3 groups receiving solrikitug with each a different dose and 1 group will receive a placebo. Participants will have a 5 in 7 chance of receiving solrikitug, and a 2 in 7 chance of receiving placebo. Participants will receive the study medicine once every four weeks. Participants who complete the treatment period will be invited to participate in the open-label period where all will receive solrikitug at a set dose.Approximately 157 adult participants will take part in this study at study sites worldwide. NI One, Inc. doing business as Uniquity One is the Sponsor that will be responsible for funding the research of this clinical study.
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
24/LO/0676
Date of REC Opinion
29 Oct 2024
REC opinion
Further Information Favourable Opinion