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

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Alergo Med Osrodek Badan Klinicznych Sp. z o.o. Tarnow Poland
Gyncentrum Sp. z o.o. Katowice Poland
ALL-MED Specialistyczna Opieka Medyczna. Medyczny Instytut Badawczy Wroclaw Poland

Other Sites

Site Name City Country Status
Medical Center Hera EOOD Sofia Bulgaria
Centrum Medyczne All-Med Badania Kliniczne Cracow Poland
Bio Zdrowie Sp. z o.o. Bialystok Poland
Uniwersytecki Szpital Kliniczny W Opolu Opole Poland
Diagnostic Consultative Centre Ascendent OOD Sofia Bulgaria
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov Sofia Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Alergologia Plus Sp. z o.o. Poznan Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Cracow Poland
Centrum Nowoczesnych Terapii Dobry Lekarz Sp. z o.o. Cracow Poland
Dtkiunzvk Shr z ojts Wroclaw Poland
Pisohis Sdx z ozyr Katowice Poland
Ljajojs Sioisgxzmchaxkw Gyxzfex Dxhvoftcfzhnmob Lublin Poland
Mbacxkc Cjqiie Meyeicfjzb &wpnbtn Bhkfrn Burgas Bulgaria
Mkhfvuu Cwzerp Muuobxhvri Pltcmz Ozo Pleven Bulgaria
Ucyh Crqtoijl Tviobv Sat z oomt Lodz Poland
Palqiibk Gtbkwmk Idrtbbcqozxjagiwkdajigjbnfxag Zhpdj Seevomlbqh Bialystok Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
14.05.2026
Poland Poland
Recruiting
14.05.2026

Trial locations

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.

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.

Trial ID:
2025-524006-14-00
Protocol code:
YH35324-201
Trial Phase:
Therapeutic exploratory (Phase II)

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