Investigating a new treatment for eosinophilic esophagitis in adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 clinical study aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics of solrikitug in adults diagnosed with eosinophilic esophagitis (EoE). The study will involve approximately 157 participants who will be randomized to receive either solrikitug at three different dose levels or a placebo, administered via subcutaneous injection over a 24-week treatment period, followed by a 28-week extension. Participants must maintain a stabilized diet and can continue on certain background medications during the study. The study will also include a post-treatment follow-up period of 16 weeks to assess long-term effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site 1039
  Dothan, Alabama, United States Recruiting
• Research Site 1015
  San Diego, California, United States Recruiting
• Research Site 1040
  Inverness, Florida, United States Recruiting
• Research Site 1001
  Jacksonville, Florida, United States Recruiting
• Research Site 1004
  Boston, Massachusetts, United States Recruiting
• Research Site 1006
  Plymouth, Minnesota, United States Recruiting

Study contacts

• Study coordinator: Uniquity One
• Email: ClinicalTrials@uniquity.com
• Phone: 484-267-2500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.