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Completed

NCT Number: NCT06438757

Trial of JYB1904 in Patients With Allergic Asthma

This phase IIa trial is meant to evaluate the pharmacokinetics, pharmacodynamics and safety of JYB1904 in patients with allergic asthma.

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Key information

Conditions

Allergic Asthma

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Shanghai General Hospital

Shanghai, Shanghai Municipality, 201203, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able to provide written informed consent voluntarily;
  • Aged 18-75 years, weight ≥ 40 kg, male or female;
  • Diagnosed Allergic asthma.

Exclusion criteria

  • Prior exposure to anti-IgE therapy within 1 year;
  • Allergic to anti-IgE biologics;
  • Current smokers, or quit smoking within 1 year;
  • Combined with other non-allergic diseases that cause IgE elevation；
  • History of malignancy, autoimmune diseases, Immune complex mediated diseases, Hypereosinophilic syndrome;
  • Other conditions unsuitable for the trial judged by the investigator.

Treatment and study plan

JYB1904

Drug

Participants will receive JYB1904 every 8 weeks for 24 weeks.

Omalizumab

Drug

Participants will receive Omalizumab every 2/4 weeks for 24 weeks.

Primary outcomes

  1. Serum concentrations of JYB1904

    Time frame: Baseline through 337 days post-dose

    Serum concentrations of JYB1904, assessed by pre-specified methods

  2. Serum concentrations of IgE

    Time frame: Baseline through 337 days post-dose

    Serum concentrations of IgE, assessed by pre-specified methods

  3. Adverse Events(AEs)

    Time frame: Baseline through 337 days post-dose

    Incidence and features of AEs assessed by CTCAE v5.0, and related safety parameters analysis

Secondary outcomes

  1. Times of protocol-defined asthma exacerbations during the 24-week treatment period

    Time frame: Baseline through 168 days post-dose

    Times of protocol-defined asthma exacerbations during the 24-week treatment period

  2. Change in spirometry measures of forced expiratory volume in one second (FEV1) in 24 weeks

    Time frame: Baseline through 24 weeks post-dose

    forced expiratory volume in one second (FEV1)

  3. Serum concentrations of anti-drug antibody (ADA)

    Time frame: Baseline through 337 days post-dose

    Serum ADA assessed by pre-specified methods, and related immunogenic features analysis

Sponsors and collaborators

Lead sponsor

Jemincare

Industry

Registry information

Official study title

Phase IIa Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety of JYB1904 in Patients With Allergic Asthma

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 3, 2024
Registry last updated
Jun 15, 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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