Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
Recruiting
Phase 2
Interventional Study
Allergic Diseases
Chronic Spontaneous Urticaria (CSU)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 150 (estimated)
- Sponsor
- Yuhan Corporation · Industry
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About This Trial
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…
Trial Locations
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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 a…
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