Trial of JYB1904 in Patients With Allergic Asthma

May 5, 2025 updated by: Jemincare

Phase IIa Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety 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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 201203
        • Shanghai General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Omalizumab
Drug: Omalizumab
Participants will receive Omalizumab every 2/4 weeks for 24 weeks.
Experimental: JYB1904: Dose-1
Drug: JYB1904
Participants will receive JYB1904 every 8 weeks for 24 weeks.
Experimental: JYB1904: Dose-2
Drug: JYB1904
Participants will receive JYB1904 every 8 weeks for 24 weeks.
Experimental: JYB1904: Dose-3
Drug: JYB1904
Participants will receive JYB1904 every 8 weeks for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum concentrations of JYB1904
Time Frame: Baseline through 337 days post-dose
Serum concentrations of JYB1904, assessed by pre-specified methods
Baseline through 337 days post-dose
Serum concentrations of IgE
Time Frame: Baseline through 337 days post-dose
Serum concentrations of IgE, assessed by pre-specified methods
Baseline through 337 days post-dose
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
Baseline through 337 days post-dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline through 168 days post-dose
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)
Baseline through 24 weeks post-dose
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
Baseline through 337 days post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jemincare

Investigators

  • Study Chair: Min Zhang, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2024

Primary Completion (Estimated)

October 31, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

May 27, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JYB1904-201

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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