Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
ConditionChronic Spontaneous Urticaria
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorJemincare
About this trial
This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
Eligibility criteria
Qualifiers
Male or female participant must be ≥18 years old at the time of signing the informed consent.
Participants are diagnosed with CSU for ≥6 months before screening.
Participants suffer from itching and hives for at least 6 consecutive weeks at any time before screening.
UAS7 (range 0~42) ≥16, ISS7 (range 0~21) ≥8 during 7 days before randomization.
Disqualifiers
Participants who suffer from inducible urticaria with definite inducements, including urticaria factitia (dermatographism), cold contact, heat contact, solar, pressure, delayed pressure, aquagenic, cholinergic or contact urticaria, etc.
Participants who suffer from any other skin diseases with chronic itching, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis, etc.
Participants who suffer from other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria or acquired/drug-induced urticaria.
Participants who are contraindicated or hypersensitive to antihistamines or any of its component (such as fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine).
Trial design
Treatments tested in this trial
- JYB1904
- Placebo+JYB1904
Treatment groups
180 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov