Trial of JYB1904 in Chronic Spontaneous Urticaria.

Last updated: November 26, 2024
Sponsor: Jemincare
Overall Status: Active - Recruiting

Phase

2

Condition

Hives (Urticaria)

Urticaria

Treatment

Omalizumab

JYB1904

Clinical Study ID

NCT06509334
JYB1904-202
  • Ages > 18
  • All Genders

Study 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

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 -

  1. ≥ 6 within 7 days prior to randomization.

Exclusion

Exclusion Criteria:

  • Induced urticaria with a defined trigger, including artificial urticaria (cutaneousscratches), 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 theopinion of the investigator may affect the study assessment and study results

  • Other conditions with symptoms of urticaria or angioedema, including but not limitedto 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 anyof the ingredients.

Study Design

Total Participants: 135
Treatment Group(s): 2
Primary Treatment: Omalizumab
Phase: 2
Study Start date:
August 04, 2024
Estimated Completion Date:
July 15, 2026

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

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