Trial of JYB1904 in Patients With Allergic Asthma

NCT ID: NCT06438757

Last Updated: 2025-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-19

Study Completion Date

2025-10-31

Brief Summary

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

Detailed Description

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Conditions

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Allergic Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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JYB1904: Dose-1

Group Type EXPERIMENTAL

JYB1904

Intervention Type DRUG

Participants will receive JYB1904 every 8 weeks for 24 weeks.

JYB1904: Dose-2

Group Type EXPERIMENTAL

JYB1904

Intervention Type DRUG

Participants will receive JYB1904 every 8 weeks for 24 weeks.

JYB1904: Dose-3

Group Type EXPERIMENTAL

JYB1904

Intervention Type DRUG

Participants will receive JYB1904 every 8 weeks for 24 weeks.

Omalizumab

Group Type ACTIVE_COMPARATOR

Omalizumab

Intervention Type DRUG

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

Interventions

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JYB1904

Participants will receive JYB1904 every 8 weeks for 24 weeks.

Intervention Type DRUG

Omalizumab

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jemincare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Min Zhang

Role: STUDY_CHAIR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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Shanghai General Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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JYB1904-201

Identifier Type: -

Identifier Source: org_study_id

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