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Clinical Trials in the UK / NCT06598462
Active, not recruiting Phase 2

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

NCT06598462 · tracked via the Priya Life Science UK tracker
Sponsor
Uniquity One (UNI)
Phase
Phase 2
Started
2024-10-16
Last updated
2026-03-20

Condition(s) studied

Eosinophilic Esophagitis (EoE)

Investigational drug(s) / intervention(s)

Solrikitug Low DoseSolrikitug Mid DoseSolrikitug High DosePlacebo

Solrikitug Low Dose: Solrikitug low dose subcutaneous injection

Solrikitug Mid Dose: Solrikitug mid dose subcutaneous injection

Solrikitug High Dose: Solrikitug high dose subcutaneous injection

Placebo: Placebo subcutaneous injection

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (73)

FacilityCityRegionStatus
Research Site 1039 Dothan Alabama
Research Site 1018 Glendale Arizona
Research Site 1018 Peoria Arizona
Research Site 1037 Scottsdale Arizona
Research Site 1003 Tucson Arizona
Research Site 1023 Englewood California
Research Site 1005 Irvine California
Research Site 1015 San Diego California
Research Site 1034 Aurora Colorado
Research Site 1027 Cromwell Connecticut
Research Site 1040 Inverness Florida
Research Site 1001 Jacksonville Florida
Research Site 1049 Miami Florida
Research Site 1007 Boise Idaho
Research Site 1048 Glenview Illinois
Research Site 1022 Iowa City Iowa
Research Site 1033 Topeka Kansas
Research Site 1032 Chevy Chase Maryland
Research Site 1004 Boston Massachusetts
Research Site 1024 Ann Arbor Michigan
Research Site 1013 Wyoming Michigan
Research Site 1006 Plymouth Minnesota
Research Site 1042 Creve Coeur Missouri
Research Site 1016 Reno Nevada
Research Site 1045 Freehold New Jersey
Research Site 1043 Jackson New Jersey
Research Site 1026 Chapel Hill North Carolina
Research Site 1021 High Point North Carolina
Research Site 1012 Columbus Ohio
Research Site 1020 Harrisburg Pennsylvania
Research Site 1030 Philadelphia Pennsylvania
Research Site 1014 Dallas Texas
Research Site 1008 Houston Texas
Research Site 1036 Pearland Texas
Research Site 1041 Rockwell Texas
Research Site 1002 Ogden Utah
Research Site 1019 Salt Lake City Utah
Research Site 1017 Sandy City Utah
Research Site 1108 Newcastle New South Wales
Research Site 1110 Maroochydore Queensland

+ 33 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06598462 on ClinicalTrials.gov ↗ ← All trials in the UK