A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis

Launched by UNIQUITY ONE (UNI) · Sep 13, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called NSI-8226 for adults with eosinophilic esophagitis (EoE), a condition where the esophagus (the tube that carries food to your stomach) becomes inflamed due to a high number of a type of white blood cell called eosinophils. The study aims to assess how safe and effective this treatment is for participants aged 18 to 75 who have been diagnosed with EoE and experience swallowing difficulties at least twice a week. To qualify, participants must have a stable diet for at least two months before the study and be on certain medications that have not changed in that time.

If eligible, participants will take the treatment and undergo regular assessments to monitor their health and any side effects. They will be closely observed throughout the trial to ensure safety. It’s important to note that certain people, such as those with other serious gastrointestinal conditions or who are pregnant or breastfeeding, will not be able to participate. Overall, this study is an important step in finding new ways to help those suffering from EoE.

Gender

ALL

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.
• • 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.