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New drug shows promise for swallowing disorder

NCT ID NCT06598462

Disease control Sponsor: Uniquity One (UNI) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests an experimental drug called NSI-8226 (solrikitug) in adults with eosinophilic esophagitis, a condition that causes trouble swallowing due to inflamed esophagus. About 184 participants will receive either the drug or a placebo to see if it reduces inflammation and improves swallowing symptoms. The goal is to find a safer, more effective treatment for this chronic condition.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

184 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

eosinophilic esophagitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Eosinophilic esophagitis (EOE)

Contacts and locations

Locations

  • Research Site 1001

    Jacksonville, Florida, 32256, United States

  • Research Site 1002

    Ogden, Utah, 84405, United States

  • Research Site 1003

    Tucson, Arizona, 85715, United States

  • Research Site 1004

    Boston, Massachusetts, 02111, United States

  • Research Site 1005

    Irvine, California, 92618, United States

  • Research Site 1006

    Plymouth, Minnesota, 55446, United States

  • Research Site 1007

    Boise, Idaho, 83706, United States

  • Research Site 1008

    Houston, Texas, 77494, United States

  • Research Site 1012

    Columbus, Ohio, 43213, United States

  • Research Site 1013

    Wyoming, Michigan, 49519, United States

  • Research Site 1014

    Dallas, Texas, 75230, United States

  • Research Site 1015

    San Diego, California, 92120, United States

  • Research Site 1016

    Reno, Nevada, 89511, United States

  • Research Site 1017

    Sandy City, Utah, 84092, United States

  • Research Site 1018

    Glendale, Arizona, 85306, United States

  • Research Site 1018

    Peoria, Arizona, 85306, United States

  • Research Site 1019

    Salt Lake City, Utah, 84132, United States

  • Research Site 1020

    Harrisburg, Pennsylvania, 17110, United States

  • Research Site 1021

    High Point, North Carolina, 27265, United States

  • Research Site 1022

    Iowa City, Iowa, 52242, United States

  • Research Site 1023

    Englewood, California, 90301, United States

  • Research Site 1024

    Ann Arbor, Michigan, 48109, United States

  • Research Site 1026

    Chapel Hill, North Carolina, 27599, United States

  • Research Site 1027

    Cromwell, Connecticut, 06416, United States

  • Research Site 1030

    Philadelphia, Pennsylvania, 19104, United States

  • Research Site 1032

    Chevy Chase, Maryland, 20815, United States

  • Research Site 1033

    Topeka, Kansas, 66606, United States

  • Research Site 1034

    Aurora, Colorado, 80045, United States

  • Research Site 1036

    Pearland, Texas, 77584, United States

  • Research Site 1037

    Scottsdale, Arizona, 85258, United States

  • Research Site 1039

    Dothan, Alabama, 36305, United States

  • Research Site 1040

    Inverness, Florida, 34452, United States

  • Research Site 1041

    Rockwell, Texas, 75032, United States

  • Research Site 1042

    Creve Coeur, Missouri, 63141, United States

  • Research Site 1043

    Jackson, New Jersey, 08527, United States

  • Research Site 1045

    Freehold, New Jersey, 07728, United States

  • Research Site 1048

    Glenview, Illinois, 60026, United States

  • Research Site 1049

    Miami, Florida, 33155, United States

  • Research Site 1101

    Parkville, Victoria, 3010, Australia

  • Research Site 1102

    Fitzroy, Victoria, 3065, Australia

  • Research Site 1103

    South Brisbane, Queensland, 4101, Australia

  • Research Site 1106

    Box Hill, Victoria, 3128, Australia

  • Research Site 1107

    Woolloongabba, Queensland, 4102, Australia

  • Research Site 1107

    Woolloongabba, QLD 4102, Australia

  • Research Site 1108

    Newcastle, New South Wales, 02111, Australia

  • Research Site 1109

    Murdoch, Western AUS, 6050, Australia

  • Research Site 1110

    Maroochydore, Queensland, 4558, Australia

  • Research Site 1111

    Maroochydore, QLD 4558, Australia

  • Research Site 1151

    Leuven, VLG, 3000, Belgium

  • Research Site 1152

    Bruges, 8310, Belgium

  • Research Site 1153

    Tournai, 7500, Belgium

  • Research Site 1201

    Warsaw, 04-501, Poland

  • Research Site 1202

    Szczecin, 04-501, Poland

  • Research Site 1203

    Warsaw, 00-189, Poland

  • Research Site 1204

    Warsaw, 04-141, Poland

  • Research Site 1205

    Tychy, 43-100, Poland

  • Research Site 1206

    Warsaw, 02-781, Poland

  • Research Site 1207

    Lodz, 90-752, Poland

  • Research Site 1252

    Milan, Ca'Granada, 20122, Italy

  • Research Site 1253

    Padova, IT, 35128, Italy

  • Research Site 1255

    Roma, IT, 00168, Italy

  • Research Site 1256

    Campobasso, IT, 86100, Italy

  • Research Site 1258

    Verona, 37134, Italy

  • Research Site 1259

    Pieve Emanuele, MI, 20072, Italy

  • Research Site 1302

    Rotterdam, 3000, Netherlands

  • Research Site 1303

    Maastricht, AZ, 6202, Netherlands

  • Research Site 1351

    Tomelloso, 13700, Spain

  • Research Site 1352

    Madrid, 28040, Spain

  • Research Site 1353

    Madrid, 28006, Spain

  • Research Site 1354

    Barcelona, 08022, Spain

  • Research Site 1402

    Zurich, 8044, Switzerland

  • Research Site 1551

    Whitechapel, London, E1 1BB, United Kingdom

  • Research Site 1553

    London, Tooting, SW17 0GT, United Kingdom

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