Trial of JYB1904 in Allergic Asthma

Phase 2

Recruiting

• Conditions: Allergic Asthma
• Interventions: Drug: JYB1904; Drug: Omalizumab

• Registration Number: NCT06438757
• Lead Sponsor: Jemincare

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-05-27
• Study First Submitted QC: 2024-05-27
• Study First Posted: 2024-06-03
• Study Start: 2024-06-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
JYB1904: Dose-1	JYB1904	-
JYB1904: Dose-3	JYB1904	-
Omalizumab	Omalizumab	-
JYB1904: Dose-2	JYB1904	-

Primary Outcome Measures

Name	Time	Method
Serum concentrations of JYB1904	Baseline through 337 days post-dose	Serum concentrations of JYB1904, assessed by pre-specified methods
Serum concentrations of IgE	Baseline through 337 days post-dose	Serum concentrations of IgE, assessed by pre-specified methods
Adverse Events(AEs)	Baseline through 337 days post-dose	Incidence and features of AEs assessed by CTCAE v5.0, and related safety parameters analysis

Secondary Outcome Measures

Name	Time	Method
Times of protocol-defined asthma exacerbations during the 24-week treatment period	Baseline through 168 days post-dose	Times of protocol-defined asthma exacerbations during the 24-week treatment period
Change in spirometry measures of forced expiratory volume in one second (FEV1) in 24 weeks	Baseline through 24 weeks post-dose	forced expiratory volume in one second (FEV1)
Serum concentrations of anti-drug antibody (ADA)	Baseline through 337 days post-dose	Serum ADA assessed by pre-specified methods, and related immunogenic features analysis

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, Shanghai, China