Investigating a new treatment for eosinophilic esophagitis in adults

A Phase 2, Randomized, Double-Blind, Multicenter, Placebo Controlled Study with an Open Label Extension to Investigate the Efficacy and Safety of NSI-8226 in Adults with Eosinophilic Esophagitis (ALAMERE)

This study is testing a new treatment called solrikitug to see if it helps adults with eosinophilic esophagitis feel better over a 24-week period.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 157 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Uniquity One (UNI) (Industry-sponsored)
• Locations: 13 sites (Dothan, Alabama and 12 other locations)
• Trial ID: NCT06598462 on ClinicalTrials.gov

What this trial studies

This Phase 2 clinical study aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of solrikitug in adults diagnosed with eosinophilic esophagitis (EoE). The study will involve approximately 157 participants who will be randomized to receive either solrikitug at three different dose levels or a placebo, administered via subcutaneous injection over a 24-week treatment period, followed by a 28-week extension. Participants must maintain a stabilized diet and can continue on certain background medications during the study. The study will also include a post-treatment follow-up period of 16 weeks to assess long-term effects.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 with a confirmed diagnosis of eosinophilic esophagitis and a history of dysphagia.

Not a fit: Patients who do not have eosinophilic esophagitis or those who have not responded to standard treatments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of eosinophilic esophagitis, reducing symptoms and enhancing quality of life for patients.

How similar studies have performed: Previous studies have shown promise in treating eosinophilic esophagitis with similar approaches, but this specific treatment is being evaluated for the first time.

Eligibility criteria

Key inclusion criteria

Part A

* Participant must be 18 to 75 years of age inclusive, at the time of signing the informed consent.
* Established diagnosis of EoE with a previous EGD and esophageal biopsy confirming diagnosis of EoE.
* Participants who have symptomatic EoE as defined by a history of on average at least 2 episodes of dysphagia per week in the 4 weeks prior to Screening.
* Must remain on a stabilized diet for at least 8 weeks prior to Visit 1 and during the course of the study.
* May be on any background PPI and/or STC, during the course of the study, as long as background medications have been stable for at least 8 weeks prior to the Screening and must agree to no changes to background medication or dosage unless medically indicated.
* Discontinuation of any marketed investigational drug or biologic (monoclonal or polyclonal antibody) within 30 days or 5 half-lives prior to screening, whichever is longer.
* Participants should have previously documented standard of care treatment, which could include PPI and/or STC and/or diet.

Part B

* Participants who have completed all Part A assessments, doses, and have current negative pregnancy test may have the option to participate in the extension portion of this study (Part B).

Key exclusion criteria

Part A

* Female participant who is pregnant or breastfeeding.
* Have a history or presence of any other gastrointestinal disorders such as active Helicobacter pylori infection, history of achalasia, hyper eosinophilic syndrome and eosinophilic granulomatosis with polyangiitis, esophageal varices, Crohn's disease, ulcerative colitis, inflammatory bowel disease, celiac disease, eosinophilic enteritis, gastritis, colitis, diverticulitis, irritable bowel syndrome, or other clinically significant gastrointestinal conditions as per Investigator discretion.
* Esophageal stricture that prevents the easy passage of a standard endoscope or any critical esophageal stricture that requires dilation at screening.
* Esophageal dilation performed within 8 weeks prior to screening.
* Participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody.

Part B

* Participants who, during Part A, developed a serious adverse event (SAE) and/or adverse event (AE) deemed related to study drug, which in the opinion of the investigator could indicate that continued treatment with study drug may present and unreasonable risk to the participant.
* Participants who became pregnant during Part A.
* Participants who are prematurely discontinued from study drug due to AE (patients who are prematurely discontinued from study drug due to lack of efficacy are eligible to enter Part B).
* Patients who did not undergo endoscopy with biopsies prior to receiving rescue treatment.

Where this trial is running

Dothan, Alabama and 12 other locations

• Research Site 1039 — Dothan, Alabama, United States (Recruiting)
• Research Site 1015 — San Diego, California, United States (Recruiting)
• Research Site 1040 — Inverness, Florida, United States (Recruiting)
• Research Site 1001 — Jacksonville, Florida, United States (Recruiting)
• Research Site 1004 — Boston, Massachusetts, United States (Recruiting)
• Research Site 1006 — Plymouth, Minnesota, United States (Recruiting)
• Research Site 1016 — Reno, Nevada, United States (Recruiting)
• Research Site 1020 — Harrisburg, Pennsylvania, United States (Recruiting)
• Research Site 1002 — Ogden, Utah, United States (Recruiting)
• Research Site 1017 — Sandy, Utah, United States (Recruiting)
• Research Site 1108 — New Castle, North South Wales, Australia (Recruiting)
• Research Site 1103 — South Brisbane, Queensland, Australia (Recruiting)
• Research Site 1102 — Fitzroy, Victoria, Australia (Recruiting)

Study contacts

• Study coordinator: Uniquity One

Conditions Eosinophilic Esophagitis