Trial of JYB1904 in Chronic Spontaneous Urticaria.
ConditionChronic Spontaneous Urticaria
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorJemincare
About this trial
This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- JYB1904
- JYB1904
- Omalizumab
Treatment groups
135 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov