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

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)

Phase 2 Interventional Yuhan Corporation · NCT07415551

This trial tests whether lesigercept, given every four weeks, can reduce symptoms in adults whose chronic spontaneous urticaria is not controlled by second-generation H1-antihistamines.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment150 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorYuhan Corporation Industry-sponsored
Drugs / interventionsomalizumab
Locations30 sites (Sofia, Sofia and 29 other locations)
Trial IDNCT07415551 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults 18–75 with chronic spontaneous urticaria for at least six months and inadequate control on second-generation H1-antihistamines (meeting the specified symptom-score thresholds) are the intended participants.

Not a fit: Patients with urticaria due to a known alternative cause (for example inducible urticaria or autoimmune disease), significant uncontrolled comorbidities, recent malignancy, active high-risk infections, or pregnancy are unlikely to be eligible or to benefit from this protocol.

Why it matters

Potential benefit: If successful, lesigercept could reduce urticaria symptoms for patients who do not respond adequately to H1-antihistamines and expand treatment options.

How similar studies have performed: Other biologic therapies such as omalizumab have shown clear benefit in antihistamine-refractory CSU, but lesigercept is a newer agent with limited published clinical data to date.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Sofia, Sofia and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Allergic DiseasesChronic Spontaneous UrticariaCSUYH35324Allergic diseaseYuhanGI-301Lesigercept
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.