A Study to Investigate the Efficacy and Safety of Solrikitug in Adults with Eosinophilic Esophagitis (ALAMERE)
Summary description of the study
This study tests the investigational drug Solrikitug (NSI-8226, formerly MK-8226) in participants with eosinophilic esophagitis (EoE). The study is "double-blind". Neither the participants nor the doctors, study team, or sponsors know which treatment group the participants are assigned to. Participants initially undergo a run-in phase of ≤ 8 weeks to see if they can continue in the study. Those selected for the study are randomly assigned to a treatment group, like flipping a coin, and receive either Solrikitug or a placebo. The placebo looks like Solrikitug but contains no active ingredient. The study consists of two parts: • In Part A, the safety and tolerability of Solrikitug compared to placebo are investigated; at the same time, it is examined whether the investigational drug reduces inflammation of the esophagus and swallowing difficulties in participants with EoE. • In Part B, the long-term safety and tolerability of Solrikitug are investigated. Other focuses include the longer-term effects of Solrikitug, whether it can prevent tissue damage, how long Solrikitug remains in the body, and whether it leads to the formation of antibodies against Solrikitug. In Part A, 4 groups are formed, i.e. - 3 groups with Solrikitug - 1 group with placebo. Participants have a chance of 3 to 4 (75%) of receiving Solrikitug; the chance of receiving placebo in Part A is 1 to 4 (25%). Participants who complete Part A may have the opportunity to continue with Part B of the study, in which all participants receive Solrikitug for up to 28 weeks. After the last dose of the study treatment (in both Part A and Part B), follow-up visits are planned to assess the safety of the study treatment. Participants who complete the entire study are in the study for a total of 76 weeks and must come to the study center for ≤ 20 visits.
(BASEC)
Intervention under investigation
The treatment of participants varies depending on which treatment group they belong to: In Part A, they receive either Solrikitug or placebo over a period of 24 weeks.
In Part B, all participants receive Solrikitug for 28 weeks. Participants are regularly examined during this time. For example, blood and urine tests, physical examinations, and an endoscopy with biopsy collection are planned. Additionally, participants complete questionnaires about their symptoms and quality of life.
(BASEC)
Disease under investigation
The disease being studied is eosinophilic esophagitis (EoE). In people with EoE, white blood cells called eosinophils accumulate in the esophagus (i.e., where food and liquids are transported from the mouth to the stomach). This leads to inflammation and damages the esophagus, resulting in symptoms such as swallowing difficulties (dysphagia) or pain.
(BASEC)
The following criteria must be met for study participation: 1. Aged between 18 and 75 years 2. A documented EoE diagnosis must be available by the first visit 3. Potential participants must have adhered to a consistent diet for at least 8 weeks prior to the first visit and maintain it throughout the study. (BASEC)
Exclusion criteria
Patients who meet the following criteria are not eligible for the study: 1. Pregnancy or breastfeeding an infant 2. Acute or recently occurring cancer or other serious illness affecting, among other things, the esophagus, stomach, and intestines 3. Active infection with Helicobacter pylori (BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
Medpace Switzerland AG Viaduktstrass 42 4051 Basel, Switzerland
(BASEC)
Contact
Contact Person Switzerland
Luc Biedermann
0041 44255 1111
luc.biedermann@clutterusz.chUniversity Hospital Zurich Raemistrasse 100 8091 Zurich Switzerland
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
07.05.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
A Phase 2, Randomized, Double-Blind, Multicenter, Placebo Controlled Study with an Extension to Investigate the Efficacy and Safety of Solrikitug in Adults with Eosinophilic Esophagitis (ALAMERE) (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
not available
Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
not available
Link to the results in the primary register
not available