Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
135 participants
INTERVENTIONAL
2024-08-04
2026-07-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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JYB1904: Dose-1
JYB1904
Participants will receive JYB1904 at week0 and receive placebo at week4,8,12
JYB1904: Dose-2
JYB1904
Participants will receive JYB1904 at week0,8 and receive placebo at week4,12
Omalizumab
Omalizumab
Participants will receive Omalizumab every 4 weeks for 12 weeks
Interventions
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JYB1904
Participants will receive JYB1904 at week0 and receive placebo at week4,8,12
JYB1904
Participants will receive JYB1904 at week0,8 and receive placebo at week4,12
Omalizumab
Participants will receive Omalizumab every 4 weeks for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of Chronic Spontaneous Urticaria(CSU) ≥ 3 months prior to Screening Visit 1 and previously inadequately controlled with a second-generation H1 antihistamine.
* Itching and hives lasting ≥ 6 weeks prior to Screening Visit 1.
* Have a UAS7 (range 0 - 42) ≥ 16, an ISS7 (range 0 - 21) ≥ 6, and an HSS7 (range 0 - 21) ≥ 6 within 7 days prior to randomization.
Exclusion Criteria
* Any other dermatological condition with chronic itching, such as atopic dermatitis, herpetic pemphigoid, herpetic dermatitis, senile itching, or psoriasis, which in the opinion of the investigator may affect the study assessment and study results
* Other conditions with symptoms of urticaria or angioedema, including but not limited to urticarial vasculitis, pigmented urticaria, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria.
* Previous allergic reaction or poor efficacy with omalizumab.
* Contraindication or hypersensitivity to antihistamines (e.g., fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine) or any of the ingredients.
18 Years
ALL
No
Sponsors
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Jemincare
INDUSTRY
Responsible Party
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Locations
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Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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JYB1904-202
Identifier Type: -
Identifier Source: org_study_id