Trial of JYB1904 in Patients With Allergic Asthma

NCT06438757 | Active Not Recruiting Phase 2

• 1 other identifier: JYB1904-201
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Asthma

Outcome Measures

Primary Outcomes (3)

• Serum concentrations of JYB1904

  Serum concentrations of JYB1904, assessed by pre-specified methods

  Baseline through 337 days post-dose

• Serum concentrations of IgE

  Serum concentrations of IgE, assessed by pre-specified methods

  Baseline through 337 days post-dose

• Adverse Events(AEs)

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

  Baseline through 337 days post-dose

Secondary Outcomes (3)

• 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

  Baseline through 24 weeks post-dose

• Serum concentrations of anti-drug antibody (ADA)

  Baseline through 337 days post-dose

Study Arms (4)

JYB1904: Dose-1

EXPERIMENTAL

Drug: JYB1904

JYB1904: Dose-2

EXPERIMENTAL

Drug: JYB1904

JYB1904: Dose-3

EXPERIMENTAL

Drug: JYB1904

Omalizumab

ACTIVE COMPARATOR

Drug: Omalizumab

Interventions

JYB1904 DRUG

Participants will receive JYB1904 every 8 weeks for 24 weeks.

JYB1904: Dose-1; JYB1904: Dose-2; JYB1904: Dose-3

Omalizumab DRUG

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

Omalizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jemincare: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 201203, China

Location

MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Min Zhang

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 3, 2024
• Study Start: June 19, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

CN (1)