Recruiting

A study to evaluate the efficacy and safety of lesigercept in adults with chronic spontaneous urticaria who do not have enough relief from antihistamines

Verified siteInvestigational

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study aims to evaluate the effectiveness and safety of a new medication called lesigercept for adults living with Chronic Spontaneous Urticaria. This condition is characterized by the sudden appearance of hives, redness, and swelling on the skin that occurs without a known external trigger and lasts for an extended period. This research focuses on individuals whose symptoms are not sufficiently managed by H1-antihistamines, which are a common type of medication used to reduce allergic reactions and itching.

Participants in this study will receive either lesigercept or a placebo through a subcutaneous injection, which is a method of delivering medication via a needle into the fatty layer of tissue just beneath the skin. The study is designed so that neither the participants nor the researchers know which substance is being administered at any given time. Over a period of time, the way the medication affects the frequency and severity of the hives will be observed to determine if it is a safe and effective option for managing the disease.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study participation
Participation in the study involves receiving either the test medication, known as lesigercept, or a placebo, which is a subcutaneous injection (an injection under the skin) that contains no active ingredient.
The assignment of the medication is randomized, meaning the specific treatment is determined by chance, and double-blind, meaning neither the patient nor the investigators know which substance is being administered.
Step 2
Treatment phase
The lesigercept or placebo is administered via subcutaneous injection.
The effects of the medication are monitored for a period of 12 weeks.
Step 3
Evaluation of results
At week 12, the effectiveness of the treatment is measured by tracking changes in urticaria activity (skin hives) and the dermatology life quality index, which is a tool used to assess how skin conditions affect daily life.
The safety and tolerability of the medication are monitored by observing any adverse events, which are unexpected medical occurrences or side effects that happen during the study.

Who can join the trial?

10 criteria

You must have been diagnosed with Chronic Spontaneous Urticaria, which is a condition involving long-term hives and itching that appear without an obvious cause, for at least 6 months.
Your condition must not be well-managed by 2nd-generation H1-antihistamines, which are a common type of allergy medication used to reduce itching and hives.
You must have experienced itching and hives for more than 6 weeks in a row at some point before the study, even while taking allergy medication.
You must have been taking a stable dose of your allergy medication for at least 7 days before the study begins and must be able to continue taking that same dose throughout the study.
Your symptoms must meet specific severity scores, including a UAS7 (Urticaria Activity Score over 7 days) of 16 or higher, an ISS7 (Itch Severity Score over 7 days) of 8 or higher, and an HSS7 (Hive Severity Score over 7 days) of 8 or higher, measured during the week before the study starts.
Women who are able to become pregnant must have a negative pregnancy test, must not be breastfeeding, and must agree to use reliable contraception (methods to prevent pregnancy) from the start of the study until 6 months after the last dose.
Men who are sexually active with women capable of becoming pregnant must agree to use reliable contraception from the start of the study until 6 months after the last dose and must not donate sperm during this time.
You must be an adult between the ages of 18 and 75 years.
You must have taken your prescribed allergy medication at least 80% of the time during the initial screening period.
You must sign the Informed Consent Form, which is a document explaining all details of the study, and agree to follow all rules and restrictions listed in that document.

Who cannot join the trial?

19 criteria

You may be excluded if medical tests or physical exams suggest that an existing health condition is worsening or becoming unstable.
You cannot participate if you have used biological agents, which are specialized medicines made from living cells to target specific parts of the immune system, within the last 4 months or a specific timeframe based on how long the drug stays in your body.
You cannot participate if you have used doxepin (a medication used for sleep or anxiety) regularly for 5 or more consecutive days within the 2 weeks before starting the study.
You cannot participate if you have used H2 antihistamines (a type of medicine used to reduce stomach acid or allergies) or leukotriene receptor antagonists (medicines used to prevent asthma or allergy symptoms) within 1 week before the study begins.
You cannot participate if you have regularly used systemic or topical corticosteroids (strong medicines that reduce inflammation), hydroxychloroquine, methotrexate, cyclosporine, azathioprine, cyclophosphamide, tacrolimus, or mycophenolate mofetil within 4 weeks before starting the study.
You cannot participate if you have received a live vaccine (a vaccine that uses a weakened form of a germ) within 4 weeks before starting the study.
You cannot participate if you have undergone intravenous immunoglobulin G (a treatment involving antibodies given through a vein) or plasmapheresis (a process that filters the blood to remove certain substances) within 4 weeks before starting the study.
You cannot participate if you have had major surgery in the last 8 weeks or if you have surgery scheduled during the study.
In Japan, you cannot participate if you have used neurotropin, glycyrrhizin, tranexamic acid, or herbal medicines to treat hives within 2 weeks before starting the study.
You cannot participate if you have used another investigational product (a drug currently being tested in clinical trials) within the last 30 days or a specific timeframe based on how long the drug stays in your body.
You cannot participate if the doctor believes you are unable to follow the study rules, procedures, or requirements.
You cannot participate if you have significant health problems involving your heart (such as a heart attack or irregular heartbeat), brain, lungs, kidneys, liver, hormones, blood, digestive system, or immune system that could make the study unsafe or make the results hard to read.
You cannot participate if you have had a malignant tumor (cancer) in any part of your body within the last 5 years, unless it was certain specific, cured types of skin cancer.
You cannot participate if your hives are caused by something other than Chronic Spontaneous Urticaria, such as hives triggered by heat, cold, sunlight, or pressure, or if they are caused by other diseases like lupus or leukemia.
You cannot participate if you have other skin conditions that cause itching, such as atopic dermatitis (eczema) or psoriasis, or skin conditions that cause wheals (swollen skin) without itching.
You cannot participate if you have a history of hypersensitivity (severe allergic reaction) or anaphylaxis (a life-threatening allergic reaction) to the study drug or similar types of medicines.
You cannot participate if you have an active endoparasitic infection (an infection caused by tiny organisms like worms living inside the body) or are at high risk for one due to travel or health status.
You cannot participate if you have a known or suspected ongoing infectious disease, such as tuberculosis or chronic infections like Hepatitis B, Hepatitis C, or HIV.
You cannot participate if you have a history of drug or alcohol abuse within the 6 months before starting the study.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Verified
Cracow, Poland
Diagnostic Consultative Centre Ascendent OOD
Verified
Sofia, Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD
Verified
Sofia, Bulgaria

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Lesigercept is a medication given as a shot under the skin to help treat adults with chronic spontaneous urticaria (hives) that do not improve well enough with standard antihistamine medicines.

What is already known about the treatment

Lesigercept - This medication is administered as a solution through a subcutaneous injection under the skin. Currently being studied in clinical trials, it is being investigated as a potential treatment for adults suffering from chronic spontaneous urticaria, a condition involving long-lasting hives. As a fusion protein, it works at the molecular level by binding to specific proteins in the body to block the inflammatory signals that cause skin swelling and itching. It is classified pharmacologically as a biological agent designed to regulate the immune response.

Investigated diseases

Chronic Spontaneous Urticaria - This condition is characterized by the repeated appearance of itchy, raised red or skin-colored welts on the skin. These welts, known as hives, occur without an identifiable external trigger or cause. The condition is considered chronic when these skin reactions persist for six weeks or longer. The symptoms can vary in size, shape, and intensity, often appearing and disappearing throughout the day. The skin may also experience a sensation of stinging or burning alongside the itching.