Trial of JYB1904 in Allergic Asthma

Allergic Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06438757
• Other study ID #: JYB1904-201
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 21, 2024
• Est. completion date: October 31, 2025

Study information

• Verified date: May 2024
• Source: Jemincare
• Contact: Guorui Wang
• Phone: +8618115772113
• Email: wangguorui[@]jemincare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Allergic Asthma
• Asthma

Intervention

Drug:
• JYB1904
Participants will receive JYB1904 every 8 weeks for 24 weeks.
• Omalizumab
Participants will receive Omalizumab every 2/4 weeks for 24 weeks.

Locations

Country	Name	City	State
China	Shanghai General Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Jemincare

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum concentrations of JYB1904	Serum concentrations of JYB1904, assessed by pre-specified methods	Baseline through 337 days post-dose
Primary	Serum concentrations of IgE	Serum concentrations of IgE, assessed by pre-specified methods	Baseline through 337 days post-dose
Primary	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	Times of protocol-defined asthma exacerbations during the 24-week treatment period	Times of protocol-defined asthma exacerbations during the 24-week treatment period	Baseline through 168 days post-dose
Secondary	Change in spirometry measures of forced expiratory volume in one second (FEV1) in 24 weeks	forced expiratory volume in one second (FEV1)	Baseline through 24 weeks post-dose
Secondary	Serum concentrations of anti-drug antibody (ADA)	Serum ADA assessed by pre-specified methods, and related immunogenic features analysis	Baseline through 337 days post-dose