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Title: Study of Solrikitug compared to placebo for adults with Eosinophilic Esophagitis to evaluate its effectiveness and safety

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on Eosinophilic Esophagitis (EoE), a chronic inflammatory condition that affects the esophagus (the tube that connects the mouth to the stomach). The study will test a medication called Solrikitug, which is given through subcutaneous injection (an injection under the skin), comparing it with a placebo to determine how well it works in treating inflammation and swallowing difficulties in adults with this condition.

The study consists of two parts. In the first part, participants will receive either Solrikitug or a placebo to evaluate how effectively the medication reduces inflammation in the esophagus and improves swallowing problems. The second part of the study will focus on understanding the long-term safety of the medication. Throughout the study, participants will receive regular medical check-ups and various tests to monitor their condition.

During the trial, participants may receive up to 500 milligrams of Solrikitug per day. The medication will be provided as a powder for injection that will be prepared before use. The study team will monitor participants for any side effects and evaluate how well the treatment works by examining tissue samples from the esophagus and tracking improvement in swallowing ability.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening

    Your eligibility will be assessed based on specific criteria, including age (18-75 years), weight (minimum 40 kg), and confirmed diagnosis of eosinophilic esophagitis (EoE).

    You must have experienced difficulty swallowing (dysphagia) weekly in the last 4 weeks before screening.

    Your diet must have been stable for at least 8 weeks before screening.

  2. Step 2

    Medication washout period

    If you have been taking certain medications, they need to be stopped before the study:

    Stomach acid reducers (PPIs): stop for at least 3 days

    Swallowed steroid medications: stop for at least 8 weeks

    Previous treatments may continue only if medically necessary and the dose has been stable for at least 8 weeks

  3. Step 3

    Part A - Main study phase

    Duration: 24 weeks

    You will receive either Solrikitug or a placebo through injection under the skin

    Regular assessments will include tissue samples and monitoring of swallowing difficulties

    Your safety will be monitored through laboratory tests, vital signs, and heart recordings (ECG)

    The injection site will be checked regularly

  4. Step 4

    Part B - Extension phase

    Duration: Additional 28 weeks (until week 52)

    Continued treatment and monitoring of safety and effectiveness

    Regular tissue samples will be taken to check inflammation levels

    Ongoing assessment of swallowing difficulties

    Regular safety monitoring will continue

  5. Step 5

    Study completion

    Final evaluations will be performed

    Total study duration: approximately 52 weeks

    All study activities will conclude by January 31, 2027

Who can join the trial?

9 criteria

  • Age between 18 and 75 years old at the time of signing consent to participate
  • Body weight must be at least 40 kilograms during initial screening
  • Must have a confirmed diagnosis of Eosinophilic Esophagitis (EoE) before or during screening
  • Must have experienced difficulty swallowing (dysphagia) at least weekly in the 4 weeks before screening
  • Must have previous treatment with proton pump inhibitors (PPIs) - medications that reduce stomach acid. If stopping PPI treatment, must wait at least 3 days before screening
  • If previously treated with swallowed topical corticosteroids (anti-inflammatory medications), must stop treatment at least 8 weeks before screening
  • Must maintain a stable diet for at least 8 weeks before screening
  • If continuing any standard treatments, the dose must remain unchanged for at least 8 weeks and continue throughout the study
  • Cannot be using dupilumab (a medication for allergic conditions) during the study

Who cannot join the trial?

13 criteria

  • History of any autoimmune disorders (conditions where the immune system attacks healthy cells)
  • Current or recent use of systemic corticosteroids (medications that reduce inflammation throughout the body) within 4 weeks before the study
  • Active gastrointestinal infections or conditions other than Eosinophilic Esophagitis
  • History of major surgery of the gastrointestinal tract
  • Current malignancy (cancer) or history of cancer in the past 5 years
  • Severe liver disease or abnormal liver function tests
  • Pregnant or breastfeeding women
  • Participation in another clinical trial within the past 30 days
  • Known allergies to the study medication or its components
  • Immunocompromised condition (weakened immune system)
  • Significant heart, kidney, or lung disease
  • Inability to follow study procedures or attend scheduled visits
  • Use of prohibited medications that might interfere with the study drug
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Investigated drugs

Solrikitug is an investigational medication being studied for the treatment of Eosinophilic Esophagitis (EoE), a condition where the esophagus becomes inflamed due to an excess of white blood cells called eosinophils. This medication is being tested to see if it can reduce inflammation in the esophagus and improve symptoms of difficulty swallowing (dysphagia) in adults with EoE. It is being evaluated both for its immediate effects and long-term safety when used over an extended period.

What is already known about the treatment

Solrikitug – An investigational medication currently being studied in Phase 2 clinical trials for the treatment of Eosinophilic Esophagitis (EoE), a chronic inflammatory condition of the esophagus. This novel therapeutic agent is being evaluated for its ability to reduce tissue inflammation and improve swallowing difficulties (dysphagia) in adult patients with EoE. The medication is being tested in a randomized, double-blind, placebo-controlled study, with an extension phase to assess its long-term safety and effectiveness. While specific details about its mechanism of action and administration form are not provided in the source data, the drug is being investigated as a potential targeted therapy for managing inflammatory conditions of the digestive system.

Investigated diseases

Eosinophilic Esophagitis – A chronic inflammatory condition that affects the esophagus, characterized by the buildup of white blood cells called eosinophils in the esophageal tissue. The inflammation causes the esophagus to become stiff and narrow, making it difficult for food to pass through. People with this condition often experience trouble swallowing, food getting stuck in the throat, chest pain, and heartburn. The condition typically develops slowly over time and can affect both children and adults.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510849-34-00Protocol codeNSI-8226-201Estimated enrolment180 patientsSponsorNI One Inc.

sourced from the EU Clinical Trials Register and site verification

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