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NCT Number: NCT07402213

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

This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.

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Key information

Conditions

Chronic Spontaneous Urticaria Chronic Disease Chronic Urticaria Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

This study is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of JYB1904 injection compared to placebo in patients with CSU inadequately controlled by second-generation H1 antihistamines.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Participants treated with stable dose of second-generation H1 antihistamines (up to 4x approved dose) for at least 6 consecutive weeks before randomization, switching medications, or changing drug dosage or frequency is not allowed within 3 weeks before randomization.
  • Participants have ≥6 days record of UAS7 before randomization.

Exclusion criteria

  • 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).
  • History of anaphylactic shock.

Treatment and study plan

JYB1904

Drug

300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from Day 1 to Week 48.

Other names: JYB1904 Injection

Placebo+JYB1904

Drug

Placebo administered SC on D1 and W12; 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from W24 to W48.

Other names: Placebo+JYB1904 Injection

Primary outcomes

  1. Urticaria Activity Score Over 7 Consecutive Days(UAS7)

    Time frame: Up to 12 weeks

    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.

Secondary outcomes

  1. Itch Severity Score Over 7 Consecutive Days(ISS7)

    Time frame: Up to 12 weeks

    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.

  2. Urticaria Activity Score Over 7 Consecutive Days(UAS7)

    Time frame: Up to 12 weeks

    Proportion of participants with UAS7=0 at W12

  3. Urticaria Activity Score Over 7 Consecutive Days(UAS7)

    Time frame: Up to 24 weeks

    Change from baseline in UAS7 at W24

  4. Urticaria Activity Score Over 7 Consecutive Days(UAS7)

    Time frame: Up to 24 weeks

    Proportion of participants with UAS7=0 at W24

  5. Itch Severity Score Over 7 Consecutive Days(ISS7)

    Time frame: Up to 24 weeks

    Change from baseline in ISS7 at W24

  6. Hive Severity Score Over 7 Consecutive Days (HSS7)

    Time frame: Up to 24 weeks

    Change from baseline in HSS7 at W12 and W24.

    The HSS7 is the sum of mean daily scores over the 7 days prior to the visit, ranging from 0 to 21 points. HSS7 = 0 indicates complete resolution of hives.

  7. Angioedema Activity Score Over 7 Consecutive Days(AAS7)

    Time frame: Up to 24 weeks

    Change from baseline in AAS7 at W12 and W24. The AAS7 is the sum of the daily scores over the 7 days prior to the visit, ranging from 0 to 105 points.AAS7 = 0 indicates no angioedema.

  8. Urticaria Activity Score Over 7 Consecutive Days(UAS7)

    Time frame: Up to 24 weeks

    Proportion of participants with UAS7≤ 6 at W12 and W24

  9. Dermatology Life Quality Index(DLQI)

    Time frame: Up to 24 weeks

    Change from baseline in DLQI at W12 and W24.

    The DLQI comprises 10 questions that assess the participant's skin symptoms and the impact of their dermatological condition on multiple life domains over the past 7 days. The total score ranges from 0 to 30. The higher the score, the worse the quality of life.

  10. Efficacy Assessment Scale

    Time frame: Through study completion, an average of 72 weeks

    Change from baseline in UAS7, ISS7, HSS7, AAS7 (AAS7 only in participants with baseline AAS7>0) over time during the study

  11. Efficacy Assessment Scale

    Time frame: Through study completion, an average of 72 weeks

    Proportion of participants with UAS7=0, ISS7=0, HSS7=0, AAS7=0 (AAS7 only in participants with baseline AAS7>0) over time during the study

  12. Urticaria Activity Score Over 7 Consecutive Days(UAS7)

    Time frame: Through study completion, an average of 72 weeks

    Proportion of participants with UAS7≤ 6 over time during the study

  13. Dermatology Life Quality Index(DLQI)

    Time frame: Through study completion, an average of 72 weeks

    Change from baseline in DLQI over time during the study

  14. Dermatology Life Quality Index(DLQI)

    Time frame: Through study completion, an average of 72 weeks

    Proportion of participants with DLQI=0/1 over time during the study

  15. Urticaria Activity Score Over 7 Consecutive Days(UAS7)

    Time frame: Up to 24 weeks

    Cumulative number of weeks with UAS7 ≤ 6 by W12 and W24

  16. Angioedema Activity Score Over 7 Consecutive Days(AAS7)

    Time frame: Up to 24 weeks

    Cumulative number of weeks with AAS7 = 0 by W12 and W24

  17. Rescue Therapy

    Time frame: Up to 24 weeks

    Proportion of participants requiring rescue therapy by W12 and W24

  18. Safety and tolerability

    Time frame: Through study completion, an average of 72 weeks

    Adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination, 12-lead electrocardiogram (ECG) and laboratory results

Other outcomes

  1. Pharmacokinetic (PK) profile of JYB1904 injection

    Time frame: Through study completion, an average of 72 weeks

    Serum concentration of JYB1904

  2. Pharmacodynamic (PD) profile of JYB1904 injection

    Time frame: Through study completion, an average of 72 weeks

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

  3. Immunogenicity of JYB1904 injection

    Time frame: Through study completion, an average of 72 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mingming Tan

CONTACT

[email protected]

021-58306003

Sponsors and collaborators

Lead sponsor

Jemincare

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 11, 2026
Registry last updated
Feb 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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