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New hope for chronic hives? experimental drug lesigercept enters Mid-Stage trial

NCT ID NCT07415551

Disease control Sponsor: Yuhan Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new drug called lesigercept in 150 adults with chronic spontaneous urticaria (hives lasting 6+ months) that aren't controlled by standard antihistamines. Participants receive either lesigercept or a placebo injection. The main goal is to see if lesigercept reduces hive activity over 12 weeks. The trial also looks at safety and how well people tolerate the drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lesigercept
What this could lead to
If successful, lesigercept could offer a new treatment option for people with chronic hives that don't respond to standard antihistamines.
What could go wrong
This is an early Phase 2 study with only 150 participants, so results may not apply to everyone. The drug may not prove more effective than placebo, and side effects are still being evaluated.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Chronic spontaneous urticaria for ≥6 months, uncontrolled on 2nd-generation H1-antihistamines (UAS7≥16, ISS7≥8, HSS7≥8). * Stable dose of 2nd-generation H1-antihistamines for ≥7 days; symptom diary compliance ≥80%. * Adults 18-75 years; informed consent signed; contraception and pregnancy test requirements for both genders. * ≥80% adherence to antihistamines during screening. Exclusion Criteria: * Any medical or lab findings suggesting risk of worsening co-existing conditions during the study. * Clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematologic, gastrointestinal, or immunodeficiency disorders that may compromise safety or study results. * History of malignancy within 5 years (except certain cured skin/cervical cancers) or chronic urticaria with known etiology other than CSU (e.g., inducible urticaria, autoimmune diseases). * Active or high-risk parasitic infections, chronic/recurrent infections (e.g., TB, HBV, HCV, HIV), or hypersensitivity/anaphylaxis to study drugs or related classes. * Skin diseases affecting assessments (e.g., atopic dermatitis, psoriasis) or history of drug/alcohol abuse within 6 months.

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Conditions

The condition(s) this trial relates to.

allergic disease chronic idiopathic urticaria Chronic Urticaria

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Allergic diseases Chronic spontaneous urticaria (CSU)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    30 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • ALL-MED Specjalistyczna Opieka Medyczna

    NOT_YET_RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 53-201, Poland

  • Ajou University Hospital

    NOT_YET_RECRUITING

    Gyeonggi-do, Suwon, 16499, South Korea

  • Alergo-Med Ośrodek Badań Klinicznych Sp. z o.o.

    NOT_YET_RECRUITING

    Tarnów, Lesser Poland Voivodeship, 33-100, Poland

  • Alergologia Plus Sp. z o. o.

    NOT_YET_RECRUITING

    Poznan, Greater Poland Voivodeship, 60-693, Poland

  • Asan Medical Center

    NOT_YET_RECRUITING

    Seoul, Songpa-gu, 05505, South Korea

  • Bio Zdrowie sp. z o.o.

    NOT_YET_RECRUITING

    Bialystok, Podlaskie Voivodeship, 15-698, Poland

  • Centrum Medyczne ALL-MED

    NOT_YET_RECRUITING

    Krakow, Lesser Poland Voivodeship, 30-033, Poland

  • Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.

    NOT_YET_RECRUITING

    Krakow, Lesser Poland Voivodeship, 31-011, Poland

  • Chung-Ang University Hospital

    RECRUITING

    Seoul, Dongjak-gu, 06973, South Korea

  • Clinic Infertility Treatment Angelius Provita (Centrum Medyczne Angelius Provita)

    NOT_YET_RECRUITING

    Katowice, Silesian Voivodeship, 40-611, Poland

  • DERMACEUM sp. z o.o., DERMACEUM Centrum Medyczne

    NOT_YET_RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 53-613, Poland

  • Dermatology Hospital of Southern Medical University (Guangdong Province Dermatology Hospital)

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, 510000, China

  • Diagnostic & Consultative Centre Ascendent EOOD

    NOT_YET_RECRUITING

    Sofia, Sofia, 1202, Bulgaria

  • Hallym University Kangnam Sacred Heart Hospital

    NOT_YET_RECRUITING

    Seoul, Seoul, 07441, South Korea

  • Inha University Hospital

    NOT_YET_RECRUITING

    Incheon, Incheon, 22332, South Korea

  • Keimyung University Dongsan Hospital

    RECRUITING

    Daegu, Dalseo-gu, 42601, South Korea

  • Korea University Ansan Hospital

    NOT_YET_RECRUITING

    Gyeonggi-do, Danwon-gu, 15355, South Korea

  • Kyung Hee University Hospital at Gangdong

    NOT_YET_RECRUITING

    Seoul, Seoul, 05278, South Korea

  • Medical Center Hera EOOD

    NOT_YET_RECRUITING

    Sofia, Sofia, 1510, Bulgaria

  • NZOZ GynCentrum Oddział Libero

    NOT_YET_RECRUITING

    Katowice, Silesian Voivodeship, 40-600, Poland

  • Prof. Dorota Krasowska LUXDERM Specjalistyczny Gabinet Dermatologiczny

    NOT_YET_RECRUITING

    Lublin, Lublin Voivodeship, 20-573, Poland

  • Prywatny Gabinet Internistyczno-Alergologiczny Prof. dr hab. Zenon Siergiejko

    NOT_YET_RECRUITING

    Bialystok, Podlaskie Voivodeship, 15-010, Poland

  • Pusan National University Yangsan Hospital

    NOT_YET_RECRUITING

    Yangsan, Gyeongsangnam-do, 50612, South Korea

  • Seoul National University Bundang Hospital

    NOT_YET_RECRUITING

    Gyeonggi-do, Bundang-gu, 13620, South Korea

  • Seoul St. Mary's Hospital, The Catholic University of Korea

    RECRUITING

    Seoul, Seocho-gu, 06591, South Korea

  • Severance Hospital, Yonsei University Health System

    NOT_YET_RECRUITING

    Seoul, Seodaemun-gu, 03722, South Korea

  • The University of Hong Kong-Shenzhen Hospital

    NOT_YET_RECRUITING

    Shenzhen, Guangdong, 518053, China

  • UMHAT "Aleksandrovska"

    NOT_YET_RECRUITING

    Sofia, Sofia, 1431, Bulgaria

  • UMHATEM "N. I. Pirogov"

    NOT_YET_RECRUITING

    Sofia, Sofia, 1606, Bulgaria

  • Uniwersytecki Szpital Kliniczny w Opolu

    NOT_YET_RECRUITING

    Opole, Opolskie Voivodeship, 45-401, Poland

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