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)
1 other identifier
interventional
184
9 countries
73
Brief Summary
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2024
Typical duration for phase_2
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 13, 2024
CompletedFirst Posted
Study publicly available on registry
September 19, 2024
CompletedStudy Start
First participant enrolled
October 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
March 20, 2026
March 1, 2026
2.5 years
September 13, 2024
March 18, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Adverse events (AEs) and serious adverse events (SAEs)
To Week 24
Study Arms (4)
Solrikitug low dose
EXPERIMENTALSolrikitug
Solrikitug mid dose
EXPERIMENTALSolrikitug
Solrikitug high dose
EXPERIMENTALSolrikitug
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (73)
Research Site 1039
Dothan, Alabama, 36305, United States
Research Site 1018
Glendale, Arizona, 85306, United States
Research Site 1018
Peoria, Arizona, 85306, United States
Research Site 1037
Scottsdale, Arizona, 85258, United States
Research Site 1003
Tucson, Arizona, 85715, United States
Research Site 1023
Englewood, California, 90301, United States
Research Site 1005
Irvine, California, 92618, United States
Research Site 1015
San Diego, California, 92120, United States
Research Site 1034
Aurora, Colorado, 80045, United States
Research Site 1027
Cromwell, Connecticut, 06416, United States
Research Site 1040
Inverness, Florida, 34452, United States
Research Site 1001
Jacksonville, Florida, 32256, United States
Research Site 1049
Miami, Florida, 33155, United States
Research Site 1007
Boise, Idaho, 83706, United States
Research Site 1048
Glenview, Illinois, 60026, United States
Research Site 1022
Iowa City, Iowa, 52242, United States
Research Site 1033
Topeka, Kansas, 66606, United States
Research Site 1032
Chevy Chase, Maryland, 20815, United States
Research Site 1004
Boston, Massachusetts, 02111, United States
Research Site 1024
Ann Arbor, Michigan, 48109, United States
Research Site 1013
Wyoming, Michigan, 49519, United States
Research Site 1006
Plymouth, Minnesota, 55446, United States
Research Site 1042
Creve Coeur, Missouri, 63141, United States
Research Site 1016
Reno, Nevada, 89511, United States
Research Site 1045
Freehold, New Jersey, 07728, United States
Research Site 1043
Jackson, New Jersey, 08527, United States
Research Site 1026
Chapel Hill, North Carolina, 27599, United States
Research Site 1021
High Point, North Carolina, 27265, United States
Research Site 1012
Columbus, Ohio, 43213, United States
Research Site 1020
Harrisburg, Pennsylvania, 17110, United States
Research Site 1030
Philadelphia, Pennsylvania, 19104, United States
Research Site 1014
Dallas, Texas, 75230, United States
Research Site 1008
Houston, Texas, 77494, United States
Research Site 1036
Pearland, Texas, 77584, United States
Research Site 1041
Rockwell, Texas, 75032, United States
Research Site 1002
Ogden, Utah, 84405, United States
Research Site 1019
Salt Lake City, Utah, 84132, United States
Research Site 1017
Sandy City, Utah, 84092, United States
Research Site 1108
Newcastle, New South Wales, 02111, Australia
Research Site 1110
Maroochydore, Queensland, 4558, Australia
Research Site 1103
South Brisbane, Queensland, 4101, Australia
Research Site 1107
Woolloongabba, Queensland, 4102, Australia
Research Site 1106
Box Hill, Victoria, 3128, Australia
Research Site 1102
Fitzroy, Victoria, 3065, Australia
Research Site 1101
Parkville, Victoria, 3010, Australia
Research Site 1109
Murdoch, Western AUS, 6050, Australia
Research Site 1111
Maroochydore, QLD 4558, Australia
Research Site 1107
Woolloongabba, QLD 4102, Australia
Research Site 1151
Leuven, VLG, 3000, Belgium
Research Site 1152
Bruges, 8310, Belgium
Research Site 1153
Tournai, 7500, Belgium
Research Site 1252
Milan, Ca'Granada, 20122, Italy
Research Site 1256
Campobasso, IT, 86100, Italy
Research Site 1253
Padua, IT, 35128, Italy
Research Site 1255
Roma, IT, 00168, Italy
Research Site 1259
Pieve Emanuele, MI, 20072, Italy
Research Site 1258
Verona, 37134, Italy
Research Site 1303
Maastricht, AZ, 6202, Netherlands
Research Site 1302
Rotterdam, 3000, Netherlands
Research Site 1207
Lodz, 90-752, Poland
Research Site 1202
Szczecin, 04-501, Poland
Research Site 1205
Tychy, 43-100, Poland
Research Site 1203
Warsaw, 00-189, Poland
Research Site 1206
Warsaw, 02-781, Poland
Research Site 1204
Warsaw, 04-141, Poland
Research Site 1201
Warsaw, 04-501, Poland
Research Site 1354
Barcelona, 08022, Spain
Research Site 1353
Madrid, 28006, Spain
Research Site 1352
Madrid, 28040, Spain
Research Site 1351
Tomelloso, 13700, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Andrew W Lee, MD
Vice President, Clinical Research
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2024
First Posted
September 19, 2024
Study Start
October 16, 2024
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
March 20, 2026
Record last verified: 2026-03