Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:29 AM
Study NCT ID:
NCT07415551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multi Dose, Phase 2 Study of YH35324 in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}], 'ancestors': [{'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-07-24', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-10', 'studyFirstSubmitQcDate': '2026-02-10', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in UAS7 at Week 12', 'timeFrame': 'From first dose to Week 12'}], 'secondaryOutcomes': [{'measure': 'Proportion of participants achieving complete control (UAS7=0) at Week 12', 'timeFrame': 'From first dose to Week 12'}, {'measure': 'Proportion of participants achieving well-controlled urticaria (UAS7≤6) at Week 12', 'timeFrame': 'From first dose to Week 12'}, {'measure': 'Cumulative number of weeks with an AAS7=0 response between baseline and Week 12', 'timeFrame': 'From first dose to Week 12'}, {'measure': 'Change from baseline in DLQI score at Week 12', 'timeFrame': 'From first dose to Week 12'}, {'measure': 'Safety endpoints', 'timeFrame': 'Through study completion, approximately 113days', 'description': '• Safety endpoints will be included but not be limited to:\n\n* Occurrence of treatment emergent adverse events during the study\n* Occurrence of treatment emergent serious adverse events during the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CSU', 'YH35324', 'Allergic disease', 'Chronic Spontaneous Urticaria', 'Yuhan', 'GI-301', 'Lesigercept', 'M9010'], 'conditions': ['Allergic Diseases', 'Chronic Spontaneous Urticaria (CSU)']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\[CSU Diagnosis\\]\n\n* Chronic spontaneous urticaria for ≥6 months, uncontrolled on 2nd-generation H1-antihistamines (UAS7≥16, ISS7≥8, HSS7≥8).\n\n\\[Medication Criteria\\]\n\n\\- Stable dose of 2nd-generation H1-antihistamines for ≥7 days; symptom diary compliance ≥80%.\n\n\\[Age \\& Gender Requirements\\]\n\n\\- Adults 18-75 years; informed consent signed; contraception and pregnancy test requirements for both genders.\n\n\\[General Compliance\\]\n\n\\- ≥80% adherence to antihistamines during screening.\n\nExclusion Criteria:\n\n\\[Serious Health Risks\\] - Any medical or lab findings suggesting risk of worsening co-existing conditions during the study.\n\n\\[Major Diseases\\]\n\n\\- Clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematologic, gastrointestinal, or immunodeficiency disorders that may compromise safety or study results.\n\n\\[Cancer \\& Other Conditions\\]\n\n\\- 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).\n\n\\[Infections \\& Allergies\\]\n\n\\- Active or high-risk parasitic infections, chronic/recurrent infections (e.g., TB, HBV, HCV, HIV), or hypersensitivity/anaphylaxis to study drugs or related classes.\n\n\\[Other Exclusions\\]\n\n\\- Skin diseases affecting assessments (e.g., atopic dermatitis, psoriasis) or history of drug/alcohol abuse within 6 months.'}, 'identificationModule': {'nctId': 'NCT07415551', 'acronym': 'CLEAR', 'briefTitle': 'A Multi Dose, Phase 2 Study of YH35324 in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines', 'organization': {'class': 'INDUSTRY', 'fullName': 'Yuhan Corporation'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'YH35324-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lesigercept', 'description': '* A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group.\n* Active Dose, Q4W', 'interventionNames': ['Drug: Lesigercept']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '* A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group.\n* Q4W', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lesigercept', 'type': 'DRUG', 'description': 'Subcutaneous injection of Lesigercept', 'armGroupLabels': ['Lesigercept']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Subcutaneous injection of None of active ingredient', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1202', 'city': 'Sofia', 'state': 'Sofia', 'country': 'Bulgaria', 'facility': 'Diagnostic & Consultative Centre Ascendent EOOD'}, {'zip': '1431', 'city': 'Sofia', 'state': 'Sofia', 'country': 'Bulgaria', 'facility': 'UMHAT "Aleksandrovska"'}, {'zip': '1510', 'city': 'Sofia', 'state': 'Sofia', 'country': 'Bulgaria', 'facility': 'Medical Center Hera EOOD'}, {'zip': '1606', 'city': 'Sofia', 'state': 'Sofia', 'country': 'Bulgaria', 'facility': 'UMHATEM "N. I. Pirogov"'}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Dermatology Hospital of Southern Medical University (Guangdong Province Dermatology Hospital)', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '518053', 'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'facility': 'The University of Hong Kong-Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '60-693', 'city': 'Poznan', 'state': 'Greater Poland Voivodeship', 'country': 'Poland', 'facility': 'Alergologia Plus Sp. z o. o.', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': '30-033', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Centrum Medyczne ALL-MED', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-011', 'city': 'Krakow', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Centrum Nowoczesnych Terapii "Dobry Lekarz" Sp. z o.o.', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '33-100', 'city': 'Tarnów', 'state': 'Lesser Poland Voivodeship', 'country': 'Poland', 'facility': 'Alergo-Med Ośrodek Badań Klinicznych Sp. z o.o.', 'geoPoint': {'lat': 50.01381, 'lon': 20.98698}}, {'zip': '53-201', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'facility': 'ALL-MED Specjalistyczna Opieka Medyczna', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '53-613', 'city': 'Wroclaw', 'state': 'Lower Silesian Voivodeship', 'country': 'Poland', 'facility': 'DERMACEUM sp. z o.o., DERMACEUM Centrum Medyczne', 'geoPoint': {'lat': 51.10286, 'lon': 17.03006}}, {'zip': '20-573', 'city': 'Lublin', 'state': 'Lublin Voivodeship', 'country': 'Poland', 'facility': 'Prof. Dorota Krasowska LUXDERM Specjalistyczny Gabinet Dermatologiczny', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '45-401', 'city': 'Opole', 'state': 'Opolskie Voivodeship', 'country': 'Poland', 'facility': 'Uniwersytecki Szpital Kliniczny w Opolu', 'geoPoint': {'lat': 50.67119, 'lon': 17.92604}}, {'zip': '15-010', 'city': 'Bialystok', 'state': 'Podlaskie Voivodeship', 'country': 'Poland', 'facility': 'Prywatny Gabinet Internistyczno-Alergologiczny Prof. dr hab. Zenon Siergiejko', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '15-698', 'city': 'Bialystok', 'state': 'Podlaskie Voivodeship', 'country': 'Poland', 'facility': 'Bio Zdrowie sp. z o.o.', 'geoPoint': {'lat': 53.13333, 'lon': 23.16433}}, {'zip': '40-600', 'city': 'Katowice', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'NZOZ GynCentrum Oddział Libero', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '40-611', 'city': 'Katowice', 'state': 'Silesian Voivodeship', 'country': 'Poland', 'facility': 'Clinic Infertility Treatment Angelius Provita (Centrum Medyczne Angelius Provita)', 'geoPoint': {'lat': 50.2597, 'lon': 19.02173}}, {'zip': '13620', 'city': 'Gyeonggi-do', 'state': 'Bundang-gu', 'country': 'South Korea', 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '42601', 'city': 'Daegu', 'state': 'Dalseo-gu', 'country': 'South Korea', 'facility': 'Keimyung University Dongsan Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '15355', 'city': 'Gyeonggi-do', 'state': 'Danwon-gu', 'country': 'South Korea', 'facility': 'Korea University Ansan Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}, {'zip': '06973', 'city': 'Seoul', 'state': 'Dongjak-gu', 'country': 'South Korea', 'facility': 'Chung-Ang University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '50612', 'city': 'Yangsan', 'state': 'Gyeongsangnam-do', 'country': 'South Korea', 'facility': 'Pusan National University Yangsan Hospital', 'geoPoint': {'lat': 35.34199, 'lon': 129.03358}}, {'zip': '22332', 'city': 'Incheon', 'state': 'Incheon', 'country': 'South Korea', 'facility': 'Inha University Hospital', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}, {'zip': '06591', 'city': 'Seoul', 'state': 'Seocho-gu', 'country': 'South Korea', 'facility': "Seoul St. Mary's Hospital, The Catholic University of Korea", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '03722', 'city': 'Seoul', 'state': 'Seodaemun-gu', 'country': 'South Korea', 'facility': 'Severance Hospital, Yonsei University Health System', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05278', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Kyung Hee University Hospital at Gangdong', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '07441', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Hallym University Kangnam Sacred Heart Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '05505', 'city': 'Seoul', 'state': 'Songpa-gu', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '16499', 'city': 'Gyeonggi-do', 'state': 'Suwon', 'country': 'South Korea', 'facility': 'Ajou University Hospital', 'geoPoint': {'lat': 37.58944, 'lon': 126.76917}}], 'centralContacts': [{'name': 'JinHyun Choi', 'role': 'CONTACT', 'email': 'clinicaltrials@yuhan.co.kr', 'phone': '+82-2-828-0850'}, {'name': 'JeungJin Yoon', 'role': 'CONTACT', 'email': 'clinicaltrials@yuhan.co.kr', 'phone': '+82-2-828-0396'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Beginning 1 year and ending 5 years after all trial endpoints were assessed.', 'ipdSharing': 'YES', '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.\n\nA 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.", 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuhan Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}