NCT06509334RecruitingPhase 2
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
Jemincare1 site in 1 country135 target enrollmentStarted: August 4, 2024Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Urticaria activity score used for 7 consecutive days(UAS7)
Study Overview
Brief Summary
This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
JYB1904: Dose-1
Experimental
Intervention: JYB1904 (Drug)
JYB1904: Dose-2
Experimental
Intervention: JYB1904 (Drug)
Omalizumab
Active Comparator
Intervention: Omalizumab (Drug)
Outcomes
Primary Outcomes
Urticaria activity score used for 7 consecutive days(UAS7)
Time Frame: Baseline through 16 weeks
Change from baseline in urticaria activity score used for 7 consecutive days (UAS7) at weeks 8, 12, and 16.Score 0-42, UAS7=0 for complete remission
Secondary Outcomes
- Urticaria activity score used for 7 consecutive days(UAS7)(Baseline through 32 weeks)
- Itch severity score used for 7 consecutive days(ISS7)(Baseline through 32 weeks)
- Hive severity score used for 7 consecutive days (HSS7)(Baseline through 32 weeks)
- Angioedema activity score used for 7 consecutive days(AAS7)(Baseline through 32 weeks)
- Dermatology Life Quality Index(DLQI)(Baseline through 32 weeks)
- Safety and tolerability(Baseline through 32 weeks)
- Trends in serum total immunoglobulin E(IgE)(Baseline through 32 weeks)
- Positive detection rate of anti-drug antibody (ADA)(Baseline through 32 weeks)
Investigators
Study Sites (1)
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