NCT06509334 Trial of JYB1904 in Chronic Spontaneous Urticaria.
| NCT ID | NCT06509334 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jemincare |
| Condition | Chronic Spontaneous Urticaria |
| Study Type | INTERVENTIONAL |
| Enrollment | 135 participants |
| Start Date | 2024-08-04 |
| Primary Completion | 2026-07-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 135 participants in total. It began in 2024-08-04 with a primary completion date of 2026-07-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06509334 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chronic Spontaneous Urticaria. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06509334 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06509334 currently recruiting?
Yes, NCT06509334 is actively recruiting participants. Contact the research team at shayila@jemincare.com for enrollment information.
Where is the NCT06509334 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06509334 clinical trial?
NCT06509334 is sponsored by Jemincare. The trial plans to enroll 135 participants.