Evaluating JYB1904 for Chronic Spontaneous Urticaria

A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Adult Patients with Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines

This study is testing a new injection called JYB1904 to see if it can help adults with chronic hives and itching who haven't found relief with regular allergy medications.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 135 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jemincare (industry)
• Drugs / interventions: omalizumab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06509334 on ClinicalTrials.gov

What this trial studies

This Phase II trial aims to assess the efficacy, safety, and tolerability of JYB1904 injection in adults suffering from Chronic Spontaneous Urticaria (CSU) that has not been adequately controlled by standard antihistamines. Participants must have experienced symptoms such as itching and hives for at least six weeks prior to the screening visit. The study will compare the effects of JYB1904 against a known treatment, Omalizumab, to determine its potential benefits for managing CSU symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a diagnosis of chronic spontaneous urticaria lasting at least three months and inadequately controlled by second-generation antihistamines.

Not a fit: Patients with urticaria triggered by specific conditions or those with other chronic dermatological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for patients with chronic spontaneous urticaria who have not responded to existing therapies.

How similar studies have performed: While this approach is being evaluated in this trial, similar studies have shown promise in treating chronic spontaneous urticaria with novel therapies.

Eligibility criteria

Inclusion Criteria:

* Male or female adult subjects (≥18 years of age).
* 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:

* Induced urticaria with a defined trigger, including artificial urticaria (cutaneous scratches), cold-contact, heat-contact, solar, pressure, delayed-pressure, water-source, cholinergic, or contact urticaria
* 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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Yila Sha

Conditions: Chronic Spontaneous Urticaria