Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.

ConditionChronic Spontaneous Urticaria

Trial statusRecruiting

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

JYB1904
Drug
300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from Day 1 to Week 48.
Placebo+JYB1904
Drug
Placebo administered SC on D1 and W12; 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from W24 to W48.

Treatment groups

240 Participants

are divided into 2 treatment groups

Group A: JYB1904 Injection GroupExperimental treatment 1 intervention

Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Urticaria Activity Score Over 7 Consecutive Days(UAS7)

Change from baseline in UAS7 at W12. The UAS7 is a composite score derived from the ISS7 and the HSS7, i.e., the sum of ISS7 and HSS7, ranging from 0 to 42 points. UAS7 = 0 indicates complete resolution of urticaria.

Time frame

Up to 12 weeks

Secondary outcomes

Itch Severity Score Over 7 Consecutive Days(ISS7)

Change from baseline in ISS7 at W12. The ISS7 is the sum of mean daily scores over the 7 days prior to the visit, ranging from 0 to 21 points. ISS7 = 0 indicates complete resolution of itch.

Time frame

Up to 12 weeks

Urticaria Activity Score Over 7 Consecutive Days(UAS7)

Proportion of participants with UAS7=0 at W12

Time frame

Up to 12 weeks

Urticaria Activity Score Over 7 Consecutive Days(UAS7)

Change from baseline in UAS7 at W24

Time frame

Up to 24 weeks

Urticaria Activity Score Over 7 Consecutive Days(UAS7)

Proportion of participants with UAS7=0 at W24

Time frame

Up to 24 weeks

Other outcomes

Pharmacokinetic (PK) profile of JYB1904 injection

Serum concentration of JYB1904

Time frame

Through study completion, an average of 72 weeks

Pharmacodynamic (PD) profile of JYB1904 injection

PD parameters: Changes in serum level of total and free IgE

Time frame

Through study completion, an average of 72 weeks

Immunogenicity of JYB1904 injection

Immunogenicity parameters: Positive detection rate of anti-drug antibodies (ADA)/neutralizing ADA (Nab), ADA onset time, duration, and titer

Time frame

Through study completion, an average of 72 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jemincare

Lead sponsor

Source ClinicalTrials.gov

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