Solrikitug High Dose: Solrikitug high dose subcutaneous injection
Placebo: Placebo subcutaneous injection
Study summary
Phase 2 study to evaluate the safety, tolerability, PK, immunogenicity, and pharmacodynamics of solrikitug in adult participants with eosinophilic esophagitis.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Histological response of peak esophageal eosinophil per HPF count of ≤6 — Week 24
Change from baseline in DSQ (Dysphagia Symptom Questionnaire) score — Week 24 The DSQ score is calculated over 14-day period and ranges from 0 to 84, with a lower score indicating less severe dysphagia.
Trial sites (73)
Facility
City
Region
Status
Research Site 1039
Dothan
Alabama
Research Site 1018
Glendale
Arizona
Research Site 1018
Peoria
Arizona
Research Site 1037
Scottsdale
Arizona
Research Site 1003
Tucson
Arizona
Research Site 1023
Englewood
California
Research Site 1005
Irvine
California
Research Site 1015
San Diego
California
Research Site 1034
Aurora
Colorado
Research Site 1027
Cromwell
Connecticut
Research Site 1040
Inverness
Florida
Research Site 1001
Jacksonville
Florida
Research Site 1049
Miami
Florida
Research Site 1007
Boise
Idaho
Research Site 1048
Glenview
Illinois
Research Site 1022
Iowa City
Iowa
Research Site 1033
Topeka
Kansas
Research Site 1032
Chevy Chase
Maryland
Research Site 1004
Boston
Massachusetts
Research Site 1024
Ann Arbor
Michigan
Research Site 1013
Wyoming
Michigan
Research Site 1006
Plymouth
Minnesota
Research Site 1042
Creve Coeur
Missouri
Research Site 1016
Reno
Nevada
Research Site 1045
Freehold
New Jersey
Research Site 1043
Jackson
New Jersey
Research Site 1026
Chapel Hill
North Carolina
Research Site 1021
High Point
North Carolina
Research Site 1012
Columbus
Ohio
Research Site 1020
Harrisburg
Pennsylvania
Research Site 1030
Philadelphia
Pennsylvania
Research Site 1014
Dallas
Texas
Research Site 1008
Houston
Texas
Research Site 1036
Pearland
Texas
Research Site 1041
Rockwell
Texas
Research Site 1002
Ogden
Utah
Research Site 1019
Salt Lake City
Utah
Research Site 1017
Sandy City
Utah
Research Site 1108
Newcastle
New South Wales
Research Site 1110
Maroochydore
Queensland
+ 33 more sites — see the full list on the official registry below.
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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