Trial of JYB1904 in Patients With Allergic Asthma

Jemincare

Status and phase: Active, not recruiting; Phase 2

Conditions: Allergic Asthma

Treatments: Drug: Omalizumab; Drug: JYB1904

Study type: Interventional

Funder types: Industry

Identifiers

NCT06438757

JYB1904-201

Details and patient eligibility

About

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

Enrollment: 69 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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69 participants in 4 patient groups

JYB1904: Dose-1

Experimental group

Treatment:

Drug: JYB1904

JYB1904: Dose-2

Experimental group

Treatment:

Drug: JYB1904

JYB1904: Dose-3

Experimental group

Treatment:

Drug: JYB1904

Omalizumab

Active Comparator group

Treatment:

Drug: Omalizumab