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NCT Number: NCT06509334

Trial of JYB1904 in Chronic Spontaneous Urticaria.

This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in 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 2

Primary location

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

JYB1904

Drug

Participants will receive JYB1904 at week0 and receive placebo at week4,8,12

Omalizumab

Drug

Participants will receive Omalizumab every 4 weeks for 12 weeks

Primary outcomes

  1. Urticaria activity score used for 7 consecutive days(UAS7)

    Time frame: 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 outcomes

  1. Urticaria activity score used for 7 consecutive days(UAS7)

    Time frame: Baseline through 32 weeks

    Change from baseline in UAS7 at weeks 4, 24 and 32.Score 0-42, UAS7=0 for complete remission

  2. Itch severity score used for 7 consecutive days(ISS7)

    Time frame: 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

  3. Hive severity score used for 7 consecutive days (HSS7)

    Time frame: 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

  4. Angioedema activity score used for 7 consecutive days(AAS7)

    Time frame: 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

  5. Urticaria activity score used for 7 consecutive days(UAS7)

    Time frame: Baseline through 32 weeks

    Proportion of subjects with UAS7=0 at weeks 4, 8, 12, 16, 24, 32.Score 0-42, UAS7=0 for complete remission

  6. Dermatology Life Quality Index(DLQI)

    Time frame: 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

  7. Safety and tolerability

    Time frame: Baseline through 32 weeks

    Adverse events (AEs) and serious adverse events (SAEs)

  8. Trends in serum total immunoglobulin E(IgE)

    Time frame: Baseline through 32 weeks

    Serum total IgE levels at weeks 4, 8, 12, 16, 24 and 32

  9. Positive detection rate of anti-drug antibody (ADA)

    Time frame: Baseline through 32 weeks

    ADA positive detection rate at 32 weeks

Study contacts

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

Yila Sha

CONTACT

[email protected]

86-021-52887926

Sponsors and collaborators

Lead sponsor

Jemincare

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Adult Patients with Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 19, 2024
Registry last updated
Nov 29, 2024

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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