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

Study Purpose

Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06598462
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Uniquity One (UNI)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Andrew W Lee, MD
Principal Investigator Affiliation	Vice President, Clinical Research
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Australia, Belgium, Italy, Poland, Spain, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Eosinophilic Esophagitis (EoE)

Additional Details

This is a 24-week randomized, double-blind, placebo-controlled Phase 2 clinical study with a 28-week extension to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of 3 dose levels of solrikitug versus placebo on top of standard of care in adult participants with EoE. Approximately 180 adult participants with EoE will be randomized at approximately 80 sites. Participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 24-week treatment period followed by a 28-week extension period. The study also includes a post-treatment follow-up period of 16 weeks.

Arms & Interventions

Arms

Experimental: Solrikitug low dose

Solrikitug

Experimental: Solrikitug mid dose

Solrikitug

Experimental: Solrikitug high dose

Solrikitug

Placebo Comparator: Placebo

Placebo

Interventions

Drug: - Solrikitug Low Dose

Solrikitug low dose subcutaneous injection

Drug: - Solrikitug Mid Dose

Solrikitug mid dose subcutaneous injection

Drug: - Solrikitug High Dose

Solrikitug high dose subcutaneous injection

Other: - Placebo

Placebo subcutaneous injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site 1039, Dothan 4059102, Alabama 4829764

Status

Recruiting

Address

Research Site 1039

Dothan 4059102, Alabama 4829764, 36305

Site Contact

Research Site

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