#1 Clinical Trials Search in Europe

Solrikitug

Clinical trials are investigating Solrikitug in adults with eosinophilic esophagitis, a condition that causes inflammation in the esophagus and trouble swallowing. These studies are looking at whether Solrikitug can improve signs of disease and how safe and tolerable it is over time.

Table of Contents

Trial overview

The clinical trial NCT06598462 is an interventional Phase 2 study of Solrikitug in adults with eosinophilic esophagitis (EoE).[1] The study is authorised and plans to enroll 180 participants.[1]

This trial is designed to look at both efficacy (whether the treatment helps) and safety (whether it can be used safely in the study setting).[1]

Who can participate

The trial is for adults with eosinophilic esophagitis.[1] The source data do not list more detailed eligibility rules, so the exact age limits, symptom requirements, and other entry criteria are not provided here.[1]

Because the study compares Solrikitug with placebo in Part A, some participants will receive the study drug and some will receive a matching placebo.[1] A placebo is a look-alike treatment that does not contain the active study medicine.[1]

What is being measured

In Part A, researchers are checking whether Solrikitug lowers the peak eosinophil count in biopsy samples to 6 or fewer eosinophils per high-power field at Week 24.[1] Eosinophils are a type of white blood cell, and a high count in the esophagus can show inflammation.[1]

They are also measuring the change in the DSQ total score from baseline to Week 24.[1] The DSQ is a symptom score for swallowing problems, so a change in this score helps show whether dysphagia is improving or worsening.[1]

In Part B, the study focuses on long-term safety and tolerability.[1] The main safety outcomes include the incidence and severity of treatment-emergent adverse events (new medical problems that happen during the study), laboratory evaluations, vital signs, 12-lead ECG results, and injection site tolerability.[1]

Study parts and design

The study has two parts.[1] Part A compares Solrikitug with placebo to assess effects on tissue inflammation and dysphagia symptoms.[1]

Part B looks at longer-term safety and tolerability of Solrikitug.[1] The trial uses a subcutaneous injection form of Solrikitug at 500 mg, as listed in the study data.[1]

What this means for patients

For adults living with eosinophilic esophagitis, this study is trying to answer two main questions: does Solrikitug improve signs of disease, and is it safe enough for longer use in the study setting?[1]

The trial is not a completed treatment guide; it is a research study meant to collect evidence about outcomes that matter to patients, such as swallowing symptoms, tissue inflammation, and safety checks.[1]

Trial ID Phase Condition studied Status Enrollment
NCT06598462 Phase 2 Eosinophilic Esophagitis Authorised 180

FAQ

  • What is being studied in Solrikitug trials? The trials are studying whether Solrikitug can reduce inflammation in the esophagus and improve swallowing symptoms in adults with eosinophilic esophagitis.
  • Who can take part in these trials? The study is for adults with eosinophilic esophagitis. The trial data do not list other detailed eligibility rules.
  • What phase is the Solrikitug study? This is a Phase 2 trial. Phase 2 studies usually look at early signs of benefit and continue to collect safety information.
  • What outcomes are the researchers measuring? Researchers are measuring eosinophil counts in biopsy samples, changes in dysphagia symptom scores, and safety measures such as lab tests, vital signs, ECG results, and injection site tolerability.
  • Is the trial only about short-term results? No. Part A looks at efficacy at Week 24, and Part B looks at longer-term safety and tolerability.

Ongoing Clinical Trials on Solrikitug

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

    Not recruiting

    1
    Investigated diseases:
    Investigated drugs:
    Belgium Italy The Netherlands Poland Spain

Glossary

  • Eosinophilic esophagitis: A disease where a type of white blood cell called eosinophils builds up in the esophagus and causes swelling and trouble swallowing.
  • Esophagus: The tube that carries food and liquids from the mouth to the stomach.
  • Eosinophils: White blood cells that are part of the immune system. Too many in the esophagus can be a sign of inflammation.
  • Biopsy: A small sample of tissue taken for testing under a microscope.
  • HPF: High-power field, a microscope viewing area used to count cells in tissue samples.
  • Dysphagia: Difficulty swallowing.
  • DSQ total score: A symptom score used to measure swallowing problems. A change in the score can show whether symptoms are getting better or worse.
  • Placebo: A treatment that looks like the study drug but does not contain the active medicine.
  • Adverse events: Unwanted medical problems that happen during a study. They may or may not be caused by the study treatment.
  • ECG: Electrocardiogram, a test that records the heart’s electrical activity.

References