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

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)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Eosinophilic Esophagitis (EoE)
• Intervention / Treatment: Other: Placebo; Biological: Solrikitug Low Dose; Biological: Solrikitug Mid Dose; Biological: Solrikitug High Dose

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Maroochydore, Australia, QLD 4558
    • Research Site 1111
  • Woolloongabba, Australia, QLD 4102
    • Research Site 1107
  • New South Wales
    • Newcastle, New South Wales, Australia, 02111
      • Research Site 1108
  • Queensland
    • Maroochydore, Queensland, Australia, 4558
      • Research Site 1110
    • South Brisbane, Queensland, Australia, 4101
      • Research Site 1103
    • Woolloongabba, Queensland, Australia, 4102
      • Research Site 1107
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Research Site 1106
    • Fitzroy, Victoria, Australia, 3065
      • Research Site 1102
    • Parkville, Victoria, Australia, 3010
      • Research Site 1101
  • Western AUS
    • Murdoch, Western AUS, Australia, 6050
      • Research Site 1109
• Belgium
  • Bruges, Belgium, 8310
    • Research Site 1152
  • Tournai, Belgium, 7500
    • Research Site 1153
  • VLG
    • Leuven, VLG, Belgium, 3000
      • Research Site 1151
• Italy
  • Verona, Italy, 37134
    • Research Site 1258
  • Ca'Granada
    • Milan, Ca'Granada, Italy, 20122
      • Research Site 1252
  • IT
    • Campobasso, IT, Italy, 86100
      • Research Site 1256
    • Padua, IT, Italy, 35128
      • Research Site 1253
    • Roma, IT, Italy, 00168
      • Research Site 1255
  • MI
    • Pieve Emanuele, MI, Italy, 20072
      • Research Site 1259
• Netherlands
  • Rotterdam, Netherlands, 3000
    • Research Site 1302
  • AZ
    • Maastricht, AZ, Netherlands, 6202
      • Research Site 1303
• Poland
  • Lodz, Poland, 90-752
    • Research Site 1207
  • Szczecin, Poland, 04-501
    • Research Site 1202
  • Tychy, Poland, 43-100
    • Research Site 1205
  • Warsaw, Poland, 00-189
    • Research Site 1203
  • Warsaw, Poland, 02-781
    • Research Site 1206
  • Warsaw, Poland, 04-141
    • Research Site 1204
  • Warsaw, Poland, 04-501
    • Research Site 1201
• Spain
  • Barcelona, Spain, 08022
    • Research Site 1354
  • Madrid, Spain, 28006
    • Research Site 1353
  • Madrid, Spain, 28040
    • Research Site 1352
  • Tomelloso, Spain, 13700
    • Research Site 1351
• Switzerland
  • Zurich, Switzerland, 8044
    • Research Site 1402
• United Kingdom
  • London
    • Whitechapel, London, United Kingdom, E1 1BB
      • Research Site 1551
  • Tooting
    • London, Tooting, United Kingdom, SW17 0GT
      • Research Site 1553
• United States
  • Alabama
    • Dothan, Alabama, United States, 36305
      • Research Site 1039
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Research Site 1018
    • Peoria, Arizona, United States, 85306
      • Research Site 1018
    • Scottsdale, Arizona, United States, 85258
      • Research Site 1037
    • Tucson, Arizona, United States, 85715
      • Research Site 1003
  • California
    • Englewood, California, United States, 90301
      • Research Site 1023
    • Irvine, California, United States, 92618
      • Research Site 1005
    • San Diego, California, United States, 92120
      • Research Site 1015
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Research Site 1034
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • Research Site 1027
  • Florida
    • Inverness, Florida, United States, 34452
      • Research Site 1040
    • Jacksonville, Florida, United States, 32256
      • Research Site 1001
    • Miami, Florida, United States, 33155
      • Research Site 1049
  • Idaho
    • Boise, Idaho, United States, 83706
      • Research Site 1007
  • Illinois
    • Glenview, Illinois, United States, 60026
      • Research Site 1048
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Research Site 1022
  • Kansas
    • Topeka, Kansas, United States, 66606
      • Research Site 1033
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Research Site 1032
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Research Site 1004
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Research Site 1024
    • Wyoming, Michigan, United States, 49519
      • Research Site 1013
  • Minnesota
    • Plymouth, Minnesota, United States, 55446
      • Research Site 1006
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Research Site 1042
  • Nevada
    • Reno, Nevada, United States, 89511
      • Research Site 1016
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Research Site 1045
    • Jackson, New Jersey, United States, 08527
      • Research Site 1043
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Research Site 1026
    • High Point, North Carolina, United States, 27265
      • Research Site 1021
  • Ohio
    • Columbus, Ohio, United States, 43213
      • Research Site 1012
  • Pennsylvania
    • Harrisburg, Pennsylvania, United States, 17110
      • Research Site 1020
    • Philadelphia, Pennsylvania, United States, 19104
      • Research Site 1030
  • Texas
    • Dallas, Texas, United States, 75230
      • Research Site 1014
    • Houston, Texas, United States, 77494
      • Research Site 1008
    • Pearland, Texas, United States, 77584
      • Research Site 1036
    • Rockwell, Texas, United States, 75032
      • Research Site 1041
  • Utah
    • Ogden, Utah, United States, 84405
      • Research Site 1002
    • Salt Lake City, Utah, United States, 84132
      • Research Site 1019
    • Sandy City, Utah, United States, 84092
      • Research Site 1017

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Placebo subcutaneous injection
Experimental: Solrikitug low dose; Solrikitug	Biological: Solrikitug Low Dose; Solrikitug low dose subcutaneous injection
Experimental: Solrikitug mid dose; Solrikitug	Biological: Solrikitug Mid Dose; Solrikitug mid dose subcutaneous injection
Experimental: Solrikitug high dose; Solrikitug	Biological: Solrikitug High Dose; Solrikitug high dose subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histological response of peak esophageal eosinophil per HPF count of ≤6		Week 24
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score	The DSQ score is calculated over 14-day period and ranges from 0 to 84, with a lower score indicating less severe dysphagia.	Week 24

Secondary Outcome Measures

Outcome Measure	Time Frame
Adverse events (AEs) and serious adverse events (SAEs)	To Week 24

Collaborators and Investigators

• Sponsor: Uniquity One (UNI)
• Investigators: Study Chair: Andrew W Lee, MD, Vice President, Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): August 31, 2027

Study Registration Dates

• First Submitted: September 13, 2024
• First Submitted That Met QC Criteria: September 13, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Digestive System Diseases; Gastrointestinal Diseases; Hypersensitivity, Immediate; Hypersensitivity; Eosinophilia; Leukocyte Disorders; Hematologic Diseases; Esophageal Diseases; Gastroenteritis; Esophagitis; Hemic and Lymphatic Diseases; Eosinophilic Esophagitis
• Other Study ID Numbers: NSI-8226-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No