Lesigercept for adults with chronic spontaneous urticaria not controlled by H1-antihistamines

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, placebo-controlled Phase 2 study will enroll about 150 adults with chronic spontaneous urticaria inadequately controlled on H1-antihistamines, including some previously treated with omalizumab. Participants are randomized 2:1 to receive lesigercept or placebo and will receive three doses administered every four weeks during a 12-week treatment period with a 4-week follow-up, for a total of 16 weeks of observation. Study assessments include symptom scores, safety monitoring, pharmacokinetics, pharmacodynamics, and immunogenicity. The trial aims to characterize the benefit-risk profile of lesigercept in this target population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Keimyung University Dongsan Hospital
  Daegu, Dalseo-gu, South Korea Recruiting
• Chung-Ang University Hospital
  Seoul, Dongjak-gu, South Korea Recruiting
• Seoul St. Mary's Hospital, The Catholic University of Korea
  Seoul, Seocho-gu, South Korea Recruiting
• Diagnostic & Consultative Centre Ascendent EOOD
  Sofia, Sofia, Bulgaria Not yet recruiting
• UMHAT "Aleksandrovska"
  Sofia, Sofia, Bulgaria Not yet recruiting
• Medical Center Hera EOOD
  Sofia, Sofia, Bulgaria Not yet recruiting

Study contacts

• Study coordinator: JinHyun Choi
• Email: clinicaltrials@yuhan.co.kr
• Phone: +82-2-828-0850

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• SKINERGY: deep biomarker profiling of immune-driven skin diseases in dermatology clinics

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.