Allergic AsthmaPhase 2NCT06438757
Trial of JYB1904 in Patients With Allergic Asthma
A Phase 2 study testing JYB1904 and Omalizumab in people with Allergic Asthma, run by Jemincare at 1 site in China.
Trial summary
This phase IIa trial is meant to evaluate the pharmacokinetics, pharmacodynamics and safety of JYB1904 in patients with allergic asthma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- JYB1904 and Omalizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 19 Jun 2024to 20 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent voluntarily;
- Aged 18-75 years, weight ≥ 40 kg, male or female;
- Diagnosed Allergic asthma.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Phase IIa Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety of JYB1904 in Patients With Allergic Asthma
This phase IIa trial is meant to evaluate the pharmacokinetics, pharmacodynamics and safety of JYB1904 in patients with allergic asthma.
- Conditions
- Allergic Asthma
- Being tested
- JYB1904, Omalizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JYB1904Drug
Participants will receive JYB1904 every 8 weeks for 24 weeks.
OmalizumabDrug
Participants will receive Omalizumab every 2/4 weeks for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| JYB1904: Dose-1 | Experimental | Not described Receives: Drug: JYB1904 |
| JYB1904: Dose-2 | Experimental | Not described Receives: Drug: JYB1904 |
| JYB1904: Dose-3 | Experimental | Not described Receives: Drug: JYB1904 |
| Omalizumab | Active comparator | Not described Receives: Drug: Omalizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentrations of JYB1904
Serum concentrations of JYB1904, assessed by pre-specified methods
Measured: Baseline through 337 days post-dose
Serum concentrations of IgE
Serum concentrations of IgE, assessed by pre-specified methods
Measured: Baseline through 337 days post-dose
Adverse Events(AEs)
Incidence and features of AEs assessed by CTCAE v5.0, and related safety parameters analysis
Measured: Baseline through 337 days post-dose
Secondary outcomes (3)
Times of protocol-defined asthma exacerbations during the 24-week treatment period
Times of protocol-defined asthma exacerbations during the 24-week treatment period
Measured: Baseline through 168 days post-dose
Change in spirometry measures of forced expiratory volume in one second (FEV1) in 24 weeks
forced expiratory volume in one second (FEV1)
Measured: Baseline through 24 weeks post-dose
Serum concentrations of anti-drug antibody (ADA)
Serum ADA assessed by pre-specified methods, and related immunogenic features analysis
Measured: Baseline through 337 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start19 Jun 2024
- Primary completion20 Nov 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic AsthmaStudies of the same condition, open and under way.
- More trials run by JemincareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Zhang, Study chair, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06438757
- Sponsor's protocol ID
- JYB1904-201
- Status last verified
- Jun 2026
- First submitted
- 27 May 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIa Trial to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety of JYB1904 in Patients With Allergic Asthma
- ClinicalTrials.gov ID
- NCT06438757
- Acronym / sponsor ID
- JYB1904-201
- Conditions
- Allergic Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 3 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase IIa trial is meant to evaluate the pharmacokinetics, pharmacodynamics and safety of JYB1904 in patients with allergic asthma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| JYB1904: Dose-1 | Experimental | Drug: JYB1904 |
| JYB1904: Dose-2 | Experimental | Drug: JYB1904 |
| JYB1904: Dose-3 | Experimental | Drug: JYB1904 |
| Omalizumab | Active comparator | Drug: Omalizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Able to provide written informed consent voluntarily;
- Aged 18-75 years, weight ≥ 40 kg, male or female;
- Diagnosed Allergic asthma.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JYB1904Participants will receive JYB1904 every 8 weeks for 24 weeks. | Drug | JYB1904: Dose-1, JYB1904: Dose-2, JYB1904: Dose-3 |
| OmalizumabParticipants will receive Omalizumab every 2/4 weeks for 24 weeks. | Drug | Omalizumab |
Primary outcome
Serum concentrations of JYB1904
Time frame: Baseline through 337 days post-dose
Serum concentrations of JYB1904, assessed by pre-specified methods
Serum concentrations of IgE
Time frame: Baseline through 337 days post-dose
Serum concentrations of IgE, assessed by pre-specified methods
Adverse Events(AEs)
Time frame: Baseline through 337 days post-dose
Incidence and features of AEs assessed by CTCAE v5.0, and related safety parameters analysis
3 secondary outcomes
Times of protocol-defined asthma exacerbations during the 24-week treatment period
Time frame: Baseline through 168 days post-dose
Change in spirometry measures of forced expiratory volume in one second (FEV1) in 24 weeks
Time frame: Baseline through 24 weeks post-dose
Serum concentrations of anti-drug antibody (ADA)
Time frame: Baseline through 337 days post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Zhang study chair
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JYB1904 and Omalizumab in people with Allergic Asthma, run by Jemincare at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentrations of JYB1904 (time frame: Baseline through 337 days post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.