Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
CLEAR
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)
1 other identifier
interventional
150
4 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2026
Shorter than P25 for phase_2
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2026
CompletedFirst Posted
Study publicly available on registry
February 17, 2026
CompletedStudy Start
First participant enrolled
March 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 24, 2027
April 15, 2026
March 1, 2026
1.2 years
February 10, 2026
April 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline Urticaria Activity Score over 7 days (UAS7) at Week 12
Urticaria Activity Score over 7 days- minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome)
From first dose to Week 12
Secondary Outcomes (5)
Proportion of participants achieving complete control (Urticaria Activity Score over 7 days=0) at Week 12
From first dose to Week 12
Proportion of participants achieving well-controlled urticaria (Urticaria Activity Score over 7 days ≤6) at Week 12
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
From first dose to Week 12
Change from baseline in Dermatology Life Quality Index(DLQI) score at Week 12
From first dose to Week 12
Occurrence and severity of adverse events (AEs)
Through study completion, approximately 113days
Study Arms (2)
Lesigercept
EXPERIMENTAL* A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group. * Active Dose, Q4W
Placebo
PLACEBO COMPARATOR* A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group. * Q4W
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Diagnostic & Consultative Centre Ascendent EOOD
Sofia, Sofia, 1202, Bulgaria
UMHAT "Aleksandrovska"
Sofia, Sofia, 1431, Bulgaria
Medical Center Hera EOOD
Sofia, Sofia, 1510, Bulgaria
UMHATEM "N. I. Pirogov"
Sofia, Sofia, 1606, Bulgaria
Dermatology Hospital of Southern Medical University (Guangdong Province Dermatology Hospital)
Guangzhou, Guangdong, 510000, China
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong, 518053, China
Alergologia Plus Sp. z o. o.
Poznan, Greater Poland Voivodeship, 60-693, Poland
Centrum Medyczne ALL-MED
Krakow, Lesser Poland Voivodeship, 30-033, Poland
Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.
Krakow, Lesser Poland Voivodeship, 31-011, Poland
Alergo-Med Ośrodek Badań Klinicznych Sp. z o.o.
Tarnów, Lesser Poland Voivodeship, 33-100, Poland
ALL-MED Specjalistyczna Opieka Medyczna
Wroclaw, Lower Silesian Voivodeship, 53-201, Poland
DERMACEUM sp. z o.o., DERMACEUM Centrum Medyczne
Wroclaw, Lower Silesian Voivodeship, 53-613, Poland
Prof. Dorota Krasowska LUXDERM Specjalistyczny Gabinet Dermatologiczny
Lublin, Lublin Voivodeship, 20-573, Poland
Uniwersytecki Szpital Kliniczny w Opolu
Opole, Opolskie Voivodeship, 45-401, Poland
Prywatny Gabinet Internistyczno-Alergologiczny Prof. dr hab. Zenon Siergiejko
Bialystok, Podlaskie Voivodeship, 15-010, Poland
Bio Zdrowie sp. z o.o.
Bialystok, Podlaskie Voivodeship, 15-698, Poland
NZOZ GynCentrum Oddział Libero
Katowice, Silesian Voivodeship, 40-600, Poland
Clinic Infertility Treatment Angelius Provita (Centrum Medyczne Angelius Provita)
Katowice, Silesian Voivodeship, 40-611, Poland
Seoul National University Bundang Hospital
Gyeonggi-do, Bundang-gu, 13620, South Korea
Keimyung University Dongsan Hospital
Daegu, Dalseo-gu, 42601, South Korea
Korea University Ansan Hospital
Gyeonggi-do, Danwon-gu, 15355, South Korea
Chung-Ang University Hospital
Seoul, Dongjak-gu, 06973, South Korea
Pusan National University Yangsan Hospital
Yangsan, Gyeongsangnam-do, 50612, South Korea
Inha University Hospital
Incheon, Incheon, 22332, South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, Seocho-gu, 06591, South Korea
Severance Hospital, Yonsei University Health System
Seoul, Seodaemun-gu, 03722, South Korea
Kyung Hee University Hospital at Gangdong
Seoul, Seoul, 05278, South Korea
Hallym University Kangnam Sacred Heart Hospital
Seoul, Seoul, 07441, South Korea
Asan Medical Center
Seoul, Songpa-gu, 05505, South Korea
Ajou University Hospital
Gyeonggi-do, Suwon, 16499, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2026
First Posted
February 17, 2026
Study Start
March 26, 2026
Primary Completion (Estimated)
June 19, 2027
Study Completion (Estimated)
July 24, 2027
Last Updated
April 15, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Beginning 1 year and ending 5 years after all trial endpoints were assessed.
- Access Criteria
- Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to jieon.lee@yuhan.co.kr.
De-identified individual participant data (including data dictionaries) that underline the results reported in study-related publications will be made available during the period beginning 1 year and ending 5 years after all trial primary and secondary endpoints were assessed. Only requests from researchers who provide a methodologically sound proposal will be reviewed and approved by the sponsor. The analysis type should be in accordance with aims in the proposal approved by the sponsor. Proposals should be directed to jieon.lee@yuhan.co.kr. A summary of the study results will be posted in the publicly accessible database (i.e. clinicaltrials.gov) no later than 1 year after the study's primary completion date.