A Multi Dose, Phase 2 Study of YH35324 in Adult Patients With Chronic Spontaneous Urticaria Who Are Inadequately Controlled by H1-Antihistamines (CLEAR)

Yuhan

Status and phase: Not yet enrolling; Phase 2

Conditions: Allergic Diseases; Chronic Spontaneous Urticaria (CSU)

Treatments: Drug: Placebo; Drug: Lesigercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT07415551

YH35324-201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

[CSU Diagnosis]

• Chronic spontaneous urticaria for ≥6 months, uncontrolled on 2nd-generation H1-antihistamines (UAS7≥16, ISS7≥8, HSS7≥8).

[Medication Criteria]

- Stable dose of 2nd-generation H1-antihistamines for ≥7 days; symptom diary compliance ≥80%.

[Age & Gender Requirements]

- Adults 18-75 years; informed consent signed; contraception and pregnancy test requirements for both genders.

[General Compliance]

- ≥80% adherence to antihistamines during screening.

Exclusion criteria

[Serious Health Risks] - Any medical or lab findings suggesting risk of worsening co-existing conditions during the study.

[Major Diseases]

- Clinically significant cardiovascular, neurological, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic, hematologic, gastrointestinal, or immunodeficiency disorders that may compromise safety or study results.

[Cancer & Other Conditions]

- 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).

[Infections & Allergies]

- Active or high-risk parasitic infections, chronic/recurrent infections (e.g., TB, HBV, HCV, HIV), or hypersensitivity/anaphylaxis to study drugs or related classes.

[Other Exclusions]

- Skin diseases affecting assessments (e.g., atopic dermatitis, psoriasis) or history of drug/alcohol abuse within 6 months.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

Lesigercept

Experimental group

Description:

* A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group. * Active Dose, Q4W

Treatment:

Drug: Lesigercept

Placebo

Placebo Comparator group

Description:

* A total of 150 participants will be randomized in a 2:1 ratio to the Lesigercept or placebo group. * Q4W

Treatment:

Drug: Placebo