Chronic Spontaneous Urticaria
Conditions
Brief summary
This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
Interventions
DRUGJYB1904
Participants will receive JYB1904 at week0 and receive placebo at week4,8,12
DRUGOmalizumab
Participants will receive Omalizumab every 4 weeks for 12 weeks
Sponsors
Jemincare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urticaria activity score used for 7 consecutive days(UAS7) | 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
| Measure | Time frame | Description |
|---|---|---|
| Itch severity score used for 7 consecutive days(ISS7) | Baseline through 32 weeks | Change from baseline in itch severity score used for 7 consecutive days(ISS7) at weeks 4, 8, 12, 16, 24 and 32.Score 0-21, ISS7=0 for complete remission of itch |
| Hive severity score used for 7 consecutive days (HSS7) | Baseline through 32 weeks | Change from baseline in hive severity score used for 7 consecutive days(HSS7) at weeks 4, 8, 12, 16, 24, 32.Score 0-21, HSS7=0 for complete remission of hives |
| Angioedema activity score used for 7 consecutive days(AAS7) | Baseline through 32 weeks | Change from baseline in angioedema activity score used for 7 consecutive days(AAS7) at weeks 4, 8, 12, 16, 24, 32.Score 0-105, higher scores mean a worse outcome |
| Urticaria activity score used for 7 consecutive days(UAS7) | Baseline through 32 weeks | Change from baseline in UAS7 at weeks 4, 24 and 32.Score 0-42, UAS7=0 for complete remission |
| Safety and tolerability | Baseline through 32 weeks | Adverse events (AEs) and serious adverse events (SAEs) |
| Trends in serum total immunoglobulin E(IgE) | Baseline through 32 weeks | Serum total IgE levels at weeks 4, 8, 12, 16, 24 and 32 |
| Positive detection rate of anti-drug antibody (ADA) | Baseline through 32 weeks | ADA positive detection rate at 32 weeks |
| Dermatology Life Quality Index(DLQI) | Baseline through 32 weeks | Change from baseline in Dermatological Life Quality Index (DLQI) at weeks 4, 8, 12, 16, 24 and 32.Score 0-30, higher scores mean a worse outcome |
Countries
China
Contacts
Primary ContactYila Sha
Outcome results
None listed