FARE - Food Allergy Research & Education Logo

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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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.
Part B.
  • - Participants who have completed all Part A assessments, doses, and have current negative pregnancy test may have the option to participate in the extension portion of this study (Part B).
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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06598462
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Uniquity One (UNI)
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Andrew W Lee, MD
Principal Investigator Affiliation Vice President, Clinical Research
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Eosinophilic Esophagitis (EoE)
Additional Details

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 157 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.

Arms & Interventions

Arms

Experimental: Solrikitug low dose

Solrikitug

Experimental: Solrikitug mid dose

Solrikitug

Experimental: Solrikitug high dose

Solrikitug

Placebo Comparator: Placebo

Placebo

Interventions

Drug: - Solrikitug Low Dose

Solrikitug low dose subcutaneous injection

Drug: - Solrikitug Mid Dose

Solrikitug mid dose subcutaneous injection

Drug: - Solrikitug High Dose

Solrikitug high dose subcutaneous injection

Other: - Placebo

Placebo subcutaneous injection

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Research Site 1039, Dothan, Alabama

Status

Recruiting

Address

Research Site 1039

Dothan, Alabama, 36305

Site Contact

Research Site

[email protected]

484-267-2500

Research Site 1015, San Diego, California

Status

Recruiting

Address

Research Site 1015

San Diego, California, 92120

Site Contact

Research Site

[email protected]

484-267-2500

Research Site 1040, Inverness, Florida

Status

Recruiting

Address

Research Site 1040

Inverness, Florida, 34452

Site Contact

Research Site

[email protected]

484-267-2500

Research Site 1001, Jacksonville, Florida

Status

Recruiting

Address

Research Site 1001

Jacksonville, Florida, 32256

Site Contact

Research Site 1001

[email protected]

484-267-2500

Research Site 1004, Boston, Massachusetts

Status

Recruiting

Address

Research Site 1004

Boston, Massachusetts, 02111

Site Contact

Research Site

[email protected]

484-267-2500

Research Site 1006, Plymouth, Minnesota

Status

Recruiting

Address

Research Site 1006

Plymouth, Minnesota, 55446

Site Contact

Research Site

[email protected]

484-267-2500

Research Site 1016, Reno, Nevada

Status

Recruiting

Address

Research Site 1016

Reno, Nevada, 89511

Site Contact

Research Site

[email protected]

484-267-2500

Research Site 1020, Harrisburg, Pennsylvania

Status

Recruiting

Address

Research Site 1020

Harrisburg, Pennsylvania, 17110

Site Contact

Research Site

[email protected]

484-267-2500

Research Site 1002, Ogden, Utah

Status

Recruiting

Address

Research Site 1002

Ogden, Utah, 84405

Site Contact

Research Site

[email protected]

484-267-2500

Research Site 1017, Sandy, Utah

Status

Recruiting

Address

Research Site 1017

Sandy, Utah, 84092

Site Contact

Research Site

[email protected]

484-267-2500

International Sites

Research Site 1108, New Castle, North South Wales, Australia

Status

Recruiting

Address

Research Site 1108

New Castle, North South Wales,

Site Contact

Research Site

[email protected]

484-267-2500

Research Site 1103, South Brisbane, Queensland, Australia

Status

Recruiting

Address

Research Site 1103

South Brisbane, Queensland, 4101

Site Contact

Research Site

[email protected]

484-267-2500

Research Site 1102, Fitzroy, Victoria, Australia

Status

Recruiting

Address

Research Site 1102

Fitzroy, Victoria, 3065

Site Contact

Research Site

[email protected]

484-267-2500

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.