Phase 2 Study of Lesigercept in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines

Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Lesigercept
  Subcutaneous injection of Lesigercept
• Препарат Placebo
  Subcutaneous injection of None of active ingredient

Первичные конечные точки

• Change from baseline Urticaria Activity Score over 7 days (UAS7) at Week 12 [Срок оценки: From first dose to Week 12]

Вторичные конечные точки (5)

• Proportion of participants achieving complete control (Urticaria Activity Score over 7 days=0) at Week 12 [Срок оценки: From first dose to Week 12]
• Proportion of participants achieving well-controlled urticaria (Urticaria Activity Score over 7 days ≤6) at Week 12 [Срок оценки: 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 [Срок оценки: From first dose to Week 12]
• Change from baseline in Dermatology Life Quality Index(DLQI) score at Week 12 [Срок оценки: From first dose to Week 12]
• Occurrence and severity of adverse events (AEs) [Срок оценки: Through study completion, approximately 113days]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Польша · 12 центров

• 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
• … и ещё 4 центра

South Korea · 12 центров

• 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
• … и ещё 4 центра

Болгария · 4 центра

• Diagnostic & Consultative Centre Ascendent EOOD — Sofia
• UMHAT "Aleksandrovska" — Sofia
• Medical Center Hera EOOD — Sofia
• UMHATEM "N. I. Pirogov" — Sofia

Китай · 2 центра

• Dermatology Hospital of Southern Medical University (Guangdong Province Dermatology Hospit — Гуанчжоу
• The University of Hong Kong-Shenzhen Hospital — Шэньчжэнь

Идентификаторы

NCT: NCT07415551 · YH35324-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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