NCT07415551 Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
| NCT ID | NCT07415551 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Yuhan Corporation |
| Condition | Allergic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2026-03-26 |
| Primary Completion | 2027-06-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2026-03-26 with a primary completion date of 2027-06-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07415551 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Allergic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07415551 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07415551 currently recruiting?
Yes, NCT07415551 is actively recruiting participants. Contact the research team at clinicaltrials@yuhan.co.kr for enrollment information.
Where is the NCT07415551 trial being conducted?
This trial is being conducted at Sofia, Bulgaria, Sofia, Bulgaria, Sofia, Bulgaria, Sofia, Bulgaria and 11 additional locations.
Who is sponsoring the NCT07415551 clinical trial?
NCT07415551 is sponsored by Yuhan Corporation. The trial plans to enroll 150 participants.