Active, not recruiting
Phase 2
A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis
Condition(s) studied
Eosinophilic Esophagitis (EoE)
Investigational drug(s) / intervention(s)
Solrikitug Low DoseSolrikitug Mid DoseSolrikitug High DosePlacebo
Solrikitug Low Dose: Solrikitug low dose subcutaneous injection
Solrikitug Mid Dose: Solrikitug mid dose subcutaneous injection
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
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.