A Study to Investigate the Efficacy and Safety of Solrikitug in Adults with Eosinophilic Esophagitis (ALAMERE)

Résumé de l'étude

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 étudiée

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)

Maladie en cours d'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)

Sponsor

Medpace Switzerland AG Viaduktstrass 42 4051 Basel, Switzerland

(BASEC)

Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)

Commission cantonale d'éthique du Vaud

(BASEC)

Date d'approbation du comité d'éthique

07.05.2025

(BASEC)

Résultats de l'essai