Chronic Spontaneous UrticariaPhase 3NCT07402213
Trial of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
A Phase 3 study testing JYB1904 in people with Chronic Spontaneous Urticaria, run by Jemincare at 1 site in China.
Trial summary
This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- JYB1904
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteChina
- Study dates
- 9 Mar 2026to 9 Jun 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female participant must be ≥18 years old at the time of signing the informed consent.
- Participants are diagnosed with CSU for ≥6 months before screening.
- Participants suffer from itching and hives for at least 6 consecutive weeks at any time before screening.
- UAS7 (range 0~42) ≥16, ISS7 (range 0~21) ≥8 during 7 days before randomization.
- Participants treated with stable dose of second-generation H1 antihistamines (up to 4x approved dose) for at least 6 consecutive weeks before randomization, switching medications, or changing drug dosage or frequency is not allowed within 3 weeks before randomization.
- Participants have ≥6 days record of UAS7 before randomization.
Who cannot join
- Participants who suffer from inducible urticaria with definite inducements, including urticaria factitia (dermatographism), cold contact, heat contact, solar, pressure, delayed pressure, aquagenic, cholinergic or contact urticaria, etc.
- Participants who suffer from any other skin diseases with chronic itching, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis, etc.
- Participants who suffer from other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria or acquired/drug-induced urticaria.
- Participants who are contraindicated or hypersensitive to antihistamines or any of its component (such as fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine).
- History of anaphylactic shock.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, 100044
Jianzhong Zhang, 010-88325471, rmzjz@126.com
Cheng Zhou, 010-88325470, rmpkzc@163.com
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines
This Phase III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
Read the detailed description
This study is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of JYB1904 injection compared to placebo in patients with CSU inadequately controlled by second-generation H1 antihistamines.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- JYB1904, Placebo+JYB1904
- Keywords
- CSU
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JYB1904Drug
Also called JYB1904 Injection
300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from Day 1 to Week 48.
Placebo+JYB1904Drug
Also called Placebo+JYB1904 Injection
Placebo administered SC on D1 and W12; 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from W24 to W48.
| Study group | Role | What they receive |
|---|---|---|
| JYB1904 Injection Group | Experimental | 300 mg JYB1904 injection administered SC Receives: Drug: JYB1904 |
| Placebo Group | Placebo comparator | Placebo and 300 mg JYB1904 injection administered SC Receives: Drug: Placebo+JYB1904 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Change from baseline in UAS7 at W12.
The UAS7 is a composite score derived from the ISS7 and the HSS7, i.e., the sum of ISS7 and HSS7, ranging from 0 to 42 points. UAS7 = 0 indicates complete resolution of urticaria.
Measured: Up to 12 weeks
Secondary outcomes (18)
Itch Severity Score Over 7 Consecutive Days(ISS7)
Change from baseline in ISS7 at W12.
The ISS7 is the sum of mean daily scores over the 7 days prior to the visit, ranging from 0 to 21 points. ISS7 = 0 indicates complete resolution of itch.
Measured: Up to 12 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Proportion of participants with UAS7=0 at W12
Measured: Up to 12 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Change from baseline in UAS7 at W24
Measured: Up to 24 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Proportion of participants with UAS7=0 at W24
Measured: Up to 24 weeks
Itch Severity Score Over 7 Consecutive Days(ISS7)
Change from baseline in ISS7 at W24
Measured: Up to 24 weeks
Hive Severity Score Over 7 Consecutive Days (HSS7)
Change from baseline in HSS7 at W12 and W24.
The HSS7 is the sum of mean daily scores over the 7 days prior to the visit, ranging from 0 to 21 points. HSS7 = 0 indicates complete resolution of hives.
Measured: Up to 24 weeks
Angioedema Activity Score Over 7 Consecutive Days(AAS7)
Change from baseline in AAS7 at W12 and W24. The AAS7 is the sum of the daily scores over the 7 days prior to the visit, ranging from 0 to 105 points.AAS7 = 0 indicates no angioedema.
Measured: Up to 24 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Proportion of participants with UAS7≤ 6 at W12 and W24
Measured: Up to 24 weeks
Dermatology Life Quality Index(DLQI)
Change from baseline in DLQI at W12 and W24.
The DLQI comprises 10 questions that assess the participant's skin symptoms and the impact of their dermatological condition on multiple life domains over the past 7 days. The total score ranges from 0 to 30. The higher the score, the worse the quality of life.
Measured: Up to 24 weeks
Efficacy Assessment Scale
Change from baseline in UAS7, ISS7, HSS7, AAS7 (AAS7 only in participants with baseline AAS7>0) over time during the study
Measured: Through study completion, an average of 72 weeks
Efficacy Assessment Scale
Proportion of participants with UAS7=0, ISS7=0, HSS7=0, AAS7=0 (AAS7 only in participants with baseline AAS7>0) over time during the study
Measured: Through study completion, an average of 72 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Proportion of participants with UAS7≤ 6 over time during the study
Measured: Through study completion, an average of 72 weeks
Dermatology Life Quality Index(DLQI)
Change from baseline in DLQI over time during the study
Measured: Through study completion, an average of 72 weeks
Dermatology Life Quality Index(DLQI)
Proportion of participants with DLQI=0/1 over time during the study
Measured: Through study completion, an average of 72 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Cumulative number of weeks with UAS7 ≤ 6 by W12 and W24
Measured: Up to 24 weeks
Angioedema Activity Score Over 7 Consecutive Days(AAS7)
Cumulative number of weeks with AAS7 = 0 by W12 and W24
Measured: Up to 24 weeks
Rescue Therapy
Proportion of participants requiring rescue therapy by W12 and W24
Measured: Up to 24 weeks
Safety and tolerability
Adverse events (AEs) and serious adverse events (SAEs), vital signs, physical examination, 12-lead electrocardiogram (ECG) and laboratory results
Measured: Through study completion, an average of 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start9 Mar 2026
- Primary completion7 Jun 2027 (estimated)
- Study completion9 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spontaneous UrticariaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianzhong Zhang, Principal investigator, Peking University People's HospitalCheng Zhou, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402213
- Sponsor's protocol ID
- JYB1904-301
- Status last verified
- Jul 2026
- First submitted
- 28 Jan 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines
- ClinicalTrials.gov ID
- NCT07402213
- Acronym / sponsor ID
- JYB1904-301
- Conditions
- Chronic Spontaneous Urticaria
- Keywords
- CSU
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 7 Jun 2027 (estimated)
- Study completion
- 9 Jun 2028 (estimated)
- First posted
- 11 Feb 2026 (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 III Trial is Meant to Evaluate the Efficacy, and Safety of JYB1904 Injection in Adult Patients With Chronic Spontaneous Urticaria.
Detailed description
This study is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of JYB1904 injection compared to placebo in patients with CSU inadequately controlled by second-generation H1 antihistamines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JYB1904 Injection Group | Experimental | Drug: JYB1904300 mg JYB1904 injection administered SC |
| Placebo Group | Placebo comparator | Drug: Placebo+JYB1904Placebo and 300 mg JYB1904 injection administered SC |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female participant must be ≥18 years old at the time of signing the informed consent.
- Participants are diagnosed with CSU for ≥6 months before screening.
- Participants suffer from itching and hives for at least 6 consecutive weeks at any time before screening.
- UAS7 (range 0~42) ≥16, ISS7 (range 0~21) ≥8 during 7 days before randomization.
- Participants treated with stable dose of second-generation H1 antihistamines (up to 4x approved dose) for at least 6 consecutive weeks before randomization, switching medications, or changing drug dosage or frequency is not allowed within 3 weeks before randomization.
Key exclusion criteria (5 listed)
- Participants who suffer from inducible urticaria with definite inducements, including urticaria factitia (dermatographism), cold contact, heat contact, solar, pressure, delayed pressure, aquagenic, cholinergic or contact urticaria, etc.
- Participants who suffer from any other skin diseases with chronic itching, such as atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis, etc.
- Participants who suffer from other diseases with symptoms of urticaria or angioedema, including but not limited to urticaria vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis, hereditary urticaria or acquired/drug-induced urticaria.
- Participants who are contraindicated or hypersensitive to antihistamines or any of its component (such as fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine).
- History of anaphylactic shock.
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 |
|---|---|---|
| JYB1904Also: JYB1904 Injection300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from Day 1 to Week 48. | Drug | JYB1904 Injection Group |
| Placebo+JYB1904Also: Placebo+JYB1904 InjectionPlacebo administered SC on D1 and W12; 300 mg JYB1904 injection administered SC every 12 weeks (Q12W) from W24 to W48. | Drug | Placebo Group |
Primary outcome
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Time frame: Up to 12 weeks
Change from baseline in UAS7 at W12. The UAS7 is a composite score derived from the ISS7 and the HSS7, i.e., the sum of ISS7 and HSS7, ranging from 0 to 42 points. UAS7 = 0 indicates complete resolution of urticaria.
18 secondary outcomes
Itch Severity Score Over 7 Consecutive Days(ISS7)
Time frame: Up to 12 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Time frame: Up to 12 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Time frame: Up to 24 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Time frame: Up to 24 weeks
Itch Severity Score Over 7 Consecutive Days(ISS7)
Time frame: Up to 24 weeks
Hive Severity Score Over 7 Consecutive Days (HSS7)
Time frame: Up to 24 weeks
Angioedema Activity Score Over 7 Consecutive Days(AAS7)
Time frame: Up to 24 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Time frame: Up to 24 weeks
Dermatology Life Quality Index(DLQI)
Time frame: Up to 24 weeks
Efficacy Assessment Scale
Time frame: Through study completion, an average of 72 weeks
Efficacy Assessment Scale
Time frame: Through study completion, an average of 72 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Time frame: Through study completion, an average of 72 weeks
Dermatology Life Quality Index(DLQI)
Time frame: Through study completion, an average of 72 weeks
Dermatology Life Quality Index(DLQI)
Time frame: Through study completion, an average of 72 weeks
Urticaria Activity Score Over 7 Consecutive Days(UAS7)
Time frame: Up to 24 weeks
Angioedema Activity Score Over 7 Consecutive Days(AAS7)
Time frame: Up to 24 weeks
Rescue Therapy
Time frame: Up to 24 weeks
Safety and tolerability
Time frame: Through study completion, an average of 72 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Jianzhong Zhang principal investigator
Peking University People's Hospital
Cheng Zhou principal investigator
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JYB1904 in people with Chronic Spontaneous Urticaria, 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Aug 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mingming Tan (021-58306003, tanmingming@jeyoupharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urticaria Activity Score Over 7 Consecutive Days(UAS7) (time frame: Up to 12 weeks). 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 3 Aug 2026.