Unknown Digestion, Kidneys & Other Organs NIHR-supported project

ALAMERE: 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 Esophagitis ( ALAMERE)

In plain English

AI plain-English summary

A drug called solrikitug is being tested in a Phase 2 clinical trial to see if it can stop the immune attack that makes swallowing painful for people with eosinophilic esophagitis (EoE). In EoE, a type of white blood cell builds up in the oesophagus, causing inflammation, scarring, and narrowing that makes food get stuck. Current treatments—steroids or strict elimination diets—are burdensome and often ineffective long-term. Solrikitug works by blocking TSLP, a protein that acts as an early trigger for the allergic immune cascade driving the disease. By intercepting this signal at the top of the chain, the drug aims to quiet the entire inflammatory response rather than treating symptoms downstream. If the trial shows solrikitug is safe and effective, it could offer EoE patients a targeted, injection-based therapy that replaces daily steroids or extreme dietary restrictions. For a condition that primarily affects children and young adults, a treatment that reduces the risk of oesophageal narrowing and emergency food impactions would be a meaningful shift in disease management. The open-label extension will also provide early data on long-term safety and durability of response.

View original technical description
Solrikitug (International Nonproprietary Name for NSI-8226, formerly known as MK-8226) is a humanized immunoglobulin (Ig) G1 monoclonal antibody (mAb) that binds to human thymic stromal lymphopoietin (TSLP). TSLP is an up-stream regulator of the T-helper 2 (Th2) immune response and has been shown to drive the Th2 inflammatory responses that are involved in allergic inflammatory disorders, including eosinophilic esophagitis (EoE). Uniquity One is developing solrikitug for the treatment of patients with EoE and other immunologic conditions. This is a Phase 2 study to assess the efficacy, safety, tolerability, pharmacokinetics (PK), and immunogenicity of solrikitug in patients with EoE.

Researchers

Jamal Hayat (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

An open-label, multicenter, dose escalation, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered ro7507062 in participants with systemic lupus erythematosus
AMETRINE-1 A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study To Assess The Efficacy And Safety Of Induction And Maintenance Therapy With Ro7790121 In Patients With Moderately To Severely Active Ulcerative Colitis - GA45329
A Phase 1/2 Study of Linvoseltamab in patients with Relapsed or Refractory Systemic Light Chain Amyloidosis
BP44315 - An open-label, multicenter, dose escalation, first-in-human study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of subcutaneously administered RO7507062 in participants with systemic lupus erythematosus
Pre-clinical efficacy and safety evaluation of MOv18 IgE, a novel class of antibody targeting alpha folate receptor for CRUKD/14/001 a Phase I first in class clinical trial.

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.