In short
Lesigercept (also known as YH35324 or GI-301) is an investigational protein-based medicine being studied for chronic spontaneous urticaria, a skin condition causing persistent hives and itching. It is given by subcutaneous injection and has no marketing authorisation, meaning it is not yet approved for use outside clinical trials. One Phase 2 trial, authorised in the EU, is testing lesigercept against placebo in 159 adults, measuring the change in a weekly urticaria activity score at week 12.
Lesigercept is an investigational substance being developed for allergic and inflammatory conditions. It is a protein-based medicine, specifically a recombinant fusion protein, given as a solution for subcutaneous injection. It is also known by the development codes YH35324 and GI-301.
Key points
- Lesigercept is an investigational recombinant fusion protein, not yet authorised as a medicine.
- It is being studied in chronic spontaneous urticaria, a condition of persistent hives and itching.
- The single EU trial is a Phase 2 study comparing lesigercept with placebo.
- The trial plans to enrol 159 adult participants.
- The main measure is the change in UAS7, a weekly urticaria activity score, at week 12.
- The trial is currently authorised but not yet recruiting or completed.
What is lesigercept?
Lesigercept is a recombinant fusion protein — a protein-based substance created by combining parts of different proteins. It is classified as an allergen, anti-inflammatory, antiallergic and antiasthmatic agent, and a skin disorder therapy. The substance has no marketing authorisation in the product records, meaning it is still an investigational medicine. The company behind its development includes Yuhan Corporation and GI Innovation.
How does lesigercept work?
Lesigercept acts as an immunoglobulin E (IgE) inhibitor. IgE is an antibody involved in allergic reactions, including the release of histamine that causes hives and itching. By blocking IgE, lesigercept aims to reduce the allergic response. It is also described as having immunosuppressant properties.
Which conditions is lesigercept studied for?
- Chronic spontaneous urticaria — a skin condition with recurrent hives and itching lasting more than six weeks without a known trigger. This is the condition being investigated in the current EU trial.
How is lesigercept given?
Lesigercept is prepared as a solution for injection and given by subcutaneous injection, meaning it is injected under the skin. The trial record does not report a specific dose, so the dose used in the study is not stated in the registry.
What do the clinical trials show?
One Phase 2 trial of lesigercept is registered in the EU Clinical Trials Information System. It is a randomised, interventional study comparing lesigercept with a placebo injection in 159 adults with chronic spontaneous urticaria. The trial is currently authorised, meaning it has received regulatory approval to proceed but has not yet reported results.
The main outcome being measured is the change from baseline in the UAS7 score at week 12. UAS7 stands for Urticaria Activity Score over 7 days — a weekly score that combines the number of hives and the intensity of itching reported by the patient.
Participants are adults, and the trial compares those receiving lesigercept by subcutaneous injection with those receiving a placebo injection containing no active ingredient.
What side effects are known?
No side effect information for lesigercept is available from the provided sources, as the trial has not yet reported results and the supplementary source does not detail adverse events.