Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequ… (NCT07415551) | Clinical Trial Compass
RecruitingPhase 2
Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
Bulgaria, China150 participantsStarted 2026-03-26
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
What they're measuring
1
Change from baseline Urticaria Activity Score over 7 days (UAS7) at Week 12