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Taking peoplePhase 2

Lesigercept for chronic spontaneous urticaria not controlled by antihistamines

Tests lesigercept in adults whose chronic spontaneous urticaria persists despite antihistamine treatment.

Key facts

Who runs it
Yuhan Corporation
Where
Bulgaria, China, Poland, and South Korea30 sites in 4 countriesChoose a country to see its sites
Trial code
Registry title
Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
Status
Recruiting
Phase
Phase 2
People taking part
150 people, planned
Started
26 Mar 2026
Expected to end
24 Jul 2027
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Lesigercept
  • Placebo
Record updated
15 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with chronic spontaneous urticaria (long-lasting hives with no known cause) not controlled by H1-antihistamines. People previously treated with omalizumab can join.

Age
18-75 years
Sex
All sexes
Disease stage
Chronic spontaneous urticaria for ≥6 months, uncontrolled (UAS7≥16, ISS7≥8, HSS7≥8).
Earlier treatment
Must be on a stable dose of 2nd-generation H1-antihistamines for ≥7 days, with ≥80% adherence during screening.

Main reasons for not taking part

  • Cancer within 5 years, except certain treated skin or cervical cancers
  • Chronic hives with another known cause, such as inducible urticaria or autoimmune diseases
  • Active or high-risk parasitic infections, or chronic or recurring infections such as TB, HBV, HCV, HIV
  • Skin diseases that affect assessments, such as atopic dermatitis or psoriasis
  • Serious heart, nerve, mental, lung, kidney, liver, blood or immune disorders, or drug/alcohol abuse within 6 months

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

This trial has no sites in United States.

It has sites in 4 countries. Choose a country to see its sites.

About the trial

What the trial wants to find out

This study aims to evaluate the efficacy and safety of lesigercept in approximately 150 participants with CSU. By enrolling participants with an inadequate response to H1-antihistamines, including those previously treated with omalizumab, this study is expected to provide evidence for the clinical utility of lesigercept and to further characterize its benefit-risk profile in the target participant population.

The 2 groups in the trial

  • LesigerceptTreatment being tested

    * A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group. * Active Dose, Q4W

  • PlaceboPlacebo, for comparison

    * A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group. * Q4W

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Efficacy, Safety and Tolerability of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines (CLEAR)
Plain-language title
Lesigercept for chronic spontaneous urticaria not controlled by antihistaminesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Fit questions
Built from NCT07415551, who can take part
Record updated
15 April 2026