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ACTIVE NOT RECRUITING

NCT06598462

PHASE2

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

Sponsor: Uniquity One (UNI)

View on ClinicalTrials.gov

Summary

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

Official title: A Phase 2, Randomized, Double-Blind, Multicenter, Placebo Controlled Study With an Extension to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis (ALAMERE)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

184

Start Date

2024-10-16

Completion Date

2027-08-31

Last Updated

2026-03-20

Healthy Volunteers

Conditions

Eosinophilic Esophagitis (EoE)

Interventions

BIOLOGICAL

Solrikitug Low Dose

Solrikitug low dose subcutaneous injection

BIOLOGICAL

Solrikitug Mid Dose

Solrikitug mid dose subcutaneous injection

BIOLOGICAL

Solrikitug High Dose

Solrikitug high dose subcutaneous injection

OTHER

Placebo

Placebo subcutaneous injection

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.

Locations (73)

Research Site 1039

Dothan, Alabama, United States

Research Site 1018

Glendale, 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 1005

Irvine, California, United States

Research Site 1015

San Diego, California, United States

Research Site 1034

Aurora, Colorado, 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 1049

Miami, Florida, United States

Research Site 1007

Boise, Idaho, United States

Research Site 1048

Glenview, 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 1024

Ann Arbor, Michigan, United States

Research Site 1013

Wyoming, Michigan, United States

Research Site 1006

Plymouth, Minnesota, United States

Research Site 1042

Creve Coeur, Missouri, 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 1030

Philadelphia, 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 1041

Rockwell, Texas, United States

Research Site 1002

Ogden, Utah, United States

Research Site 1019

Salt Lake City, 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 1101

Parkville, Victoria, Australia

Research Site 1109

Murdoch, Western AUS, Australia

Research Site 1111

Maroochydore, Australia

Research Site 1107

Woolloongabba, Australia

Research Site 1151

Leuven, VLG, Belgium

Research Site 1152

Bruges, Belgium

Research Site 1153

Tournai, Belgium

Research Site 1252

Milan, Ca'Granada, Italy

Research Site 1256

Campobasso, IT, Italy

Research Site 1253

Padova, IT, Italy

Research Site 1255

Roma, IT, Italy

Research Site 1259

Pieve Emanuele, MI, Italy

Research Site 1258

Verona, Italy

Research Site 1303

Maastricht, AZ, Netherlands

Research Site 1302

Rotterdam, Netherlands

Research Site 1207

Lodz, 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 1352

Madrid, Spain

Research Site 1351

Tomelloso, Spain

Research Site 1402

Zurich, Switzerland

Research Site 1551

Whitechapel, London, United Kingdom

Research Site 1553

London, Tooting, United Kingdom

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (73)