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)

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.

Study Overview

• Status: Recruiting
• Conditions: Allergic Diseases; Chronic Spontaneous Urticaria (CSU)
• Intervention / Treatment: Drug: Placebo; Drug: Lesigercept

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.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: JinHyun Choi; Phone Number: +82-2-828-0850; Email: clinicaltrials@yuhan.co.kr
• Study Contact Backup: Name: JeungJin Yoon; Phone Number: +82-2-828-0396; Email: clinicaltrials@yuhan.co.kr

Study Locations

• Bulgaria
  • Sofia
    • Sofia, Sofia, Bulgaria, 1202
      • Not yet recruiting
      • Diagnostic & Consultative Centre Ascendent EOOD
    • Sofia, Sofia, Bulgaria, 1431
      • Not yet recruiting
      • UMHAT "Aleksandrovska"
    • Sofia, Sofia, Bulgaria, 1510
      • Not yet recruiting
      • Medical Center Hera Eood
    • Sofia, Sofia, Bulgaria, 1606
      • Not yet recruiting
      • UMHATEM "N. I. Pirogov"
• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Not yet recruiting
      • Dermatology Hospital of Southern Medical University (Guangdong Province Dermatology Hospital)
    • Shenzhen, Guangdong, China, 518053
      • Not yet recruiting
      • The University of Hong Kong-Shenzhen Hospital
• Poland
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 60-693
      • Not yet recruiting
      • Alergologia Plus Sp. z o. o.
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 30-033
      • Not yet recruiting
      • Centrum Medyczne ALL-MED
    • Krakow, Lesser Poland Voivodeship, Poland, 31-011
      • Not yet recruiting
      • Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.
    • Tarnów, Lesser Poland Voivodeship, Poland, 33-100
      • Not yet recruiting
      • ALERGO-MED OŚRODEK BADAŃ KLINICZNYCH Sp. z o.o.
  • Lower Silesian Voivodeship
    • Wroclaw, Lower Silesian Voivodeship, Poland, 53-201
      • Not yet recruiting
      • ALL-MED Specjalistyczna Opieka Medyczna
    • Wroclaw, Lower Silesian Voivodeship, Poland, 53-613
      • Not yet recruiting
      • DERMACEUM sp. z o.o., DERMACEUM Centrum Medyczne
  • Lublin Voivodeship
    • Lublin, Lublin Voivodeship, Poland, 20-573
      • Not yet recruiting
      • Prof. Dorota Krasowska LUXDERM Specjalistyczny Gabinet Dermatologiczny
  • Opolskie Voivodeship
    • Opole, Opolskie Voivodeship, Poland, 45-401
      • Not yet recruiting
      • Uniwersytecki Szpital Kliniczny w Opolu
  • Podlaskie Voivodeship
    • Bialystok, Podlaskie Voivodeship, Poland, 15-010
      • Not yet recruiting
      • Prywatny Gabinet Internistyczno-Alergologiczny Prof. dr hab. Zenon Siergiejko
    • Bialystok, Podlaskie Voivodeship, Poland, 15-698
      • Not yet recruiting
      • Bio Zdrowie sp. z o.o.
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-600
      • Not yet recruiting
      • NZOZ GynCentrum Oddział Libero
    • Katowice, Silesian Voivodeship, Poland, 40-611
      • Not yet recruiting
      • Clinic Infertility Treatment Angelius Provita (Centrum Medyczne Angelius Provita)
• South Korea
  • Bundang-gu
    • Gyeonggi-do, Bundang-gu, South Korea, 13620
      • Not yet recruiting
      • Seoul National University Bundang Hospital
  • Dalseo-gu
    • Daegu, Dalseo-gu, South Korea, 42601
      • Recruiting
      • Keimyung University Dongsan Hospital
  • Danwon-gu
    • Gyeonggi-do, Danwon-gu, South Korea, 15355
      • Not yet recruiting
      • Korea University Ansan Hospital
  • Dongjak-gu
    • Seoul, Dongjak-gu, South Korea, 06973
      • Recruiting
      • Chung-Ang University Hospital
  • Gyeongsangnam-do
    • Yangsan, Gyeongsangnam-do, South Korea, 50612
      • Not yet recruiting
      • Pusan National University Yangsan Hospital
  • Incheon
    • Incheon, Incheon, South Korea, 22332
      • Not yet recruiting
      • Inha University Hospital
  • Seocho-gu
    • Seoul, Seocho-gu, South Korea, 06591
      • Recruiting
      • Seoul St. Mary's Hospital, The Catholic University of Korea
  • Seodaemun-gu
    • Seoul, Seodaemun-gu, South Korea, 03722
      • Not yet recruiting
      • Severance Hospital, Yonsei University Health System
  • Seoul
    • Seoul, Seoul, South Korea, 05278
      • Not yet recruiting
      • Kyung Hee University Hospital at Gangdong
    • Seoul, Seoul, South Korea, 07441
      • Not yet recruiting
      • Hallym University Kangnam Sacred Heart Hospital
  • Songpa-gu
    • Seoul, Songpa-gu, South Korea, 05505
      • Not yet recruiting
      • Asan Medical Center
  • Suwon
    • Gyeonggi-do, Suwon, South Korea, 16499
      • Not yet recruiting
      • Ajou University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lesigercept; A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group.; Active Dose, Q4W	Drug: Lesigercept; Subcutaneous injection of Lesigercept
Placebo Comparator: Placebo; A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group.; Q4W	Drug: Placebo; Subcutaneous injection of None of active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving complete control (Urticaria Activity Score over 7 days=0) at Week 12	Urticaria Activity Score over 7 days (UAS7) - minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome)	From first dose to Week 12
Proportion of participants achieving well-controlled urticaria (Urticaria Activity Score over 7 days ≤6) at Week 12	Urticaria Activity Score over 7 days (UAS7) - minimum value: 0 / maximum value: 42 - Higher scores indicate higher disease activity (worse outcome)	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	Angioedema Activity Score over 7 days (AAS7) - minimum value: 0 / maximum value: 105 - Higher scores indicate higher disease activity (worse outcome).	From first dose to Week 12
Change from baseline in Dermatology Life Quality Index(DLQI) score at Week 12	Dermatology Life Quality Index(DLQI)- minimum value: 0 / maximum value: 30 - Higher scores indicate greater impairment of quality of life (worse outcome).	From first dose to Week 12
Occurrence and severity of adverse events (AEs)	• Safety endpoints will be included but not be limited to: Occurrence of treatment emergent adverse events during the study; Occurrence of treatment emergent serious adverse events during the study	Through study completion, approximately 113days

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2026
• Primary Completion (Estimated): June 19, 2027
• Study Completion (Estimated): July 24, 2027

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 10, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Yuhan; CSU; Chronic Spontaneous Urticaria; GI-301; YH35324; Allergic disease; Lesigercept; M9010
• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Urticaria; Skin Diseases, Vascular; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Chronic Urticaria
• Other Study ID Numbers: YH35324-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: Beginning 1 year and ending 5 years after all trial endpoints were assessed.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No