A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis
NCT ID: NCT06598462
Last Updated: 2026-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
184 participants
INTERVENTIONAL
2024-10-16
2027-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Solrikitug low dose
Solrikitug
Solrikitug Low Dose
Solrikitug low dose subcutaneous injection
Solrikitug mid dose
Solrikitug
Solrikitug Mid Dose
Solrikitug mid dose subcutaneous injection
Solrikitug high dose
Solrikitug
Solrikitug High Dose
Solrikitug high dose subcutaneous injection
Placebo
Placebo
Placebo
Placebo subcutaneous injection
Interventions
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Solrikitug Mid Dose
Solrikitug mid dose subcutaneous injection
Solrikitug High Dose
Solrikitug high dose subcutaneous injection
Placebo
Placebo subcutaneous injection
Solrikitug Low Dose
Solrikitug low dose subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Uniquity One (UNI)
INDUSTRY
Responsible Party
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Principal Investigators
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Andrew W Lee, MD
Role: STUDY_CHAIR
Vice President, Clinical Research
Locations
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Research Site 1039
Dothan, Alabama, United States
Research Site 1037
Paradise Valley, Arizona, United States
Research Site 1018
Peoria, Arizona, United States
Research Site 1037
Scottsdale, Arizona, United States
Research Site 1003
Tucson, Arizona, United States
Research Site 1023
Englewood, California, United States
Research Site 1015
San Diego, California, United States
Research Site 1027
Bristol, Connecticut, United States
Research Site 1027
Cromwell, Connecticut, United States
Research Site 1040
Inverness, Florida, United States
Research Site 1001
Jacksonville, Florida, United States
Research Site 1007
Boise, Idaho, United States
Research Site 1048
Glenview, Illinois, United States
Research Site 1048
Gurnee, Illinois, United States
Research Site 1022
Iowa City, Iowa, United States
Research Site 1033
Topeka, Kansas, United States
Research Site 1032
Chevy Chase, Maryland, United States
Research Site 1004
Boston, Massachusetts, United States
Research Site 1013
Wyoming, Michigan, United States
Research Site 1006
Plymouth, Minnesota, United States
Research Site 1016
Reno, Nevada, United States
Research Site 1045
Freehold, New Jersey, United States
Research Site 1043
Jackson, New Jersey, United States
Research Site 1026
Chapel Hill, North Carolina, United States
Research Site 1021
High Point, North Carolina, United States
Research Site 1012
Columbus, Ohio, United States
Research Site 1020
Harrisburg, Pennsylvania, United States
Research Site 1014
Dallas, Texas, United States
Research Site 1008
Houston, Texas, United States
Research Site 1036
Pearland, Texas, United States
Research Site 1002
Ogden, Utah, United States
Research Site 1017
Sandy City, Utah, United States
Research Site 1108
Newcastle, New South Wales, Australia
Research Site 1110
Maroochydore, Queensland, Australia
Research Site 1103
South Brisbane, Queensland, Australia
Research Site 1107
Woolloongabba, Queensland, Australia
Research Site 1106
Box Hill, Victoria, Australia
Research Site 1102
Fitzroy, Victoria, Australia
Research Site 1109
Murdoch, Western AUS, Australia
Research Site 1111
Maroochydore, , Australia
Research Site 1107
Woolloongabba, , Australia
Research Site 1152
Bruges, , Belgium
Research Site 1153
Tournai, , Belgium
Research Site 1258
Verona, , Italy
Research Site 1207
Lodz, , Poland
Research Site 1202
Szczecin, , Poland
Research Site 1202
Szczecin, , Poland
Research Site 1205
Tychy, , Poland
Research Site 1203
Warsaw, , Poland
Research Site 1206
Warsaw, , Poland
Research Site 1204
Warsaw, , Poland
Research Site 1201
Warsaw, , Poland
Research Site 1354
Barcelona, , Spain
Research Site 1353
Madrid, , Spain
Research Site 1351
Tomelloso, , Spain
Research Site 1551
Whitechapel, London, United Kingdom
Countries
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Other Identifiers
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NSI-8226-201
Identifier Type: -
Identifier Source: org_study_id
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