Clinical trial NCT06509334: Trial of JYB1904 in Chronic Spontaneous Urticaria.
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Spontaneous Urticaria
Lead sponsor: Jemincare
Sponsor class: INDUSTRY
First posted: 2024-07-19
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Urticaria activity score used for 7 consecutive days(UAS7)
timeFrame: Baseline through 16 weeks
Secondary outcomes:
measure: Urticaria activity score used for 7 consecutive days(UAS7)
timeFrame: Baseline through 32 weeks
measure: Itch severity score used for 7 consecutive days(ISS7)
timeFrame: Baseline through 32 weeks
measure: Hive severity score used for 7 consecutive days (HSS7)
timeFrame: Baseline through 32 weeks
measure: Angioedema activity score used for 7 consecutive days(AAS7)
timeFrame: Baseline through 32 weeks
measure: Urticaria activity score used for 7 consecutive days(UAS7)
timeFrame: Baseline through 32 weeks
measure: Dermatology Life Quality Index(DLQI)
timeFrame: Baseline through 32 weeks
measure: Safety and tolerability
timeFrame: Baseline through 32 weeks
measure: Trends in serum total immunoglobulin E(IgE)
timeFrame: Baseline through 32 weeks
measure: Positive detection rate of anti-drug antibody (ADA)
timeFrame: Baseline through 32 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
References: