Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lesigercept, Placebo.
- Who it may be relevant to
- Registry conditions: Allergic Diseases, Chronic Spontaneous Urticaria (CSU). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bulgaria, China, Poland, South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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)
Overview
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.
Detailed description
A total of 150 participants will be randomized in a 2:1 ratio to either the lesigercept or placebo group. The study will proceed with a 12-week treatment period, during which the IP will be administered every 4 weeks for a total of three doses, followed by a 4-week follow-up. In total, participants will be observed for 16 weeks to evaluate efficacy, safety, PK, PD, and immunogenicity.
Interventions
- Drug Lesigercept
Subcutaneous injection of Lesigercept - Drug Placebo
Subcutaneous injection of None of active ingredient
Primary outcome measures
- Change from baseline Urticaria Activity Score over 7 days (UAS7) at Week 12 [Time frame: From first dose to Week 12]
Secondary outcome measures (5)
- Proportion of participants achieving complete control (Urticaria Activity Score over 7 days=0) at Week 12 [Time frame: From first dose to Week 12]
- Proportion of participants achieving well-controlled urticaria (Urticaria Activity Score over 7 days ≤6) at Week 12 [Time frame: From first dose to Week 12]
- Cumulative number of weeks with an Angioedema Activity Score over 7 days (AAS7)=0 response between baseline and Week 12 [Time frame: From first dose to Week 12]
- Change from baseline in Dermatology Life Quality Index(DLQI) score at Week 12 [Time frame: From first dose to Week 12]
- Occurrence and severity of adverse events (AEs) [Time frame: Through study completion, approximately 113days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Poland · 12 centers
- Alergologia Plus Sp. z o. o. — Poznan
- Centrum Medyczne ALL-MED — Krakow
- Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o. — Krakow
- Alergo-Med Ośrodek Badań Klinicznych Sp. z o.o. — Tarnów
- ALL-MED Specjalistyczna Opieka Medyczna — Wroclaw
- DERMACEUM sp. z o.o., DERMACEUM Centrum Medyczne — Wroclaw
- Prof. Dorota Krasowska LUXDERM Specjalistyczny Gabinet Dermatologiczny — Lublin
- Uniwersytecki Szpital Kliniczny w Opolu — Opole
- … and 4 more centers
South Korea · 12 centers
- Seoul National University Bundang Hospital — Gyeonggi-do
- Keimyung University Dongsan Hospital — Daegu
- Korea University Ansan Hospital — Gyeonggi-do
- Chung-Ang University Hospital — Seoul
- Pusan National University Yangsan Hospital — Yangsan
- Inha University Hospital — Incheon
- Seoul St. Mary's Hospital, The Catholic University of Korea — Seoul
- Severance Hospital, Yonsei University Health System — Seoul
- … and 4 more centers
Bulgaria · 4 centers
- Diagnostic & Consultative Centre Ascendent EOOD — Sofia
- UMHAT "Aleksandrovska" — Sofia
- Medical Center Hera EOOD — Sofia
- UMHATEM "N. I. Pirogov" — Sofia
China · 2 centers
- Dermatology Hospital of Southern Medical University (Guangdong Province Dermatology Hospit — Guangzhou
- The University of Hong Kong-Shenzhen Hospital — Shenzhen
Identifiers
NCT: NCT07415551 · YH35324-201