Chronic Spontaneous UrticariaPhase 2NCT06509334
Trial of JYB1904 in Chronic Spontaneous Urticaria.
A Phase 2 study testing JYB1904 and Omalizumab in people with Chronic Spontaneous Urticaria, run by Jemincare at 1 site in China.
Trial summary
This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in 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 and Omalizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2024to 15 Jul 2026
- Phase
- Phase 2
- 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 adult subjects (≥18 years of age).
- Diagnosis of Chronic Spontaneous Urticaria(CSU) ≥ 3 months prior to Screening Visit 1 and previously inadequately controlled with a second-generation H1 antihistamine.
- Itching and hives lasting ≥ 6 weeks prior to Screening Visit 1.
- Have a UAS7 (range 0 - 42) ≥ 16, an ISS7 (range 0 - 21) ≥ 6, and an HSS7 (range 0 - 21) ≥ 6 within 7 days prior to randomization.
Who cannot join
- Induced urticaria with a defined trigger, including artificial urticaria (cutaneous scratches), cold-contact, heat-contact, solar, pressure, delayed-pressure, water-source, cholinergic, or contact urticaria
- Any other dermatological condition with chronic itching, such as atopic dermatitis, herpetic pemphigoid, herpetic dermatitis, senile itching, or psoriasis, which in the opinion of the investigator may affect the study assessment and study results
- Other conditions with symptoms of urticaria or angioedema, including but not limited to urticarial vasculitis, pigmented urticaria, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria.
- Previous allergic reaction or poor efficacy with omalizumab.
- Contraindication or hypersensitivity to antihistamines (e.g., fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine) or any of the ingredients.
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, Beijing Municipality, 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, Parallel-group, Active-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Adult Patients with Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines
This Phase II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- JYB1904, Omalizumab
- 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
Participants will receive JYB1904 at week0 and receive placebo at week4,8,12
JYB1904Drug
Participants will receive JYB1904 at week0,8 and receive placebo at week4,12
OmalizumabDrug
Participants will receive Omalizumab every 4 weeks for 12 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 |
| 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.
Urticaria activity score used for 7 consecutive days(UAS7)
Change from baseline in urticaria activity score used for 7 consecutive days (UAS7) at weeks 8, 12, and 16.Score 0-42, UAS7=0 for complete remission
Measured: Baseline through 16 weeks
Secondary outcomes (9)
Urticaria activity score used for 7 consecutive days(UAS7)
Change from baseline in UAS7 at weeks 4, 24 and 32.Score 0-42, UAS7=0 for complete remission
Measured: Baseline through 32 weeks
Itch severity score used for 7 consecutive days(ISS7)
Change from baseline in itch severity score used for 7 consecutive days(ISS7) at weeks 4, 8, 12, 16, 24 and 32.Score 0-21, ISS7=0 for complete remission of itch
Measured: Baseline through 32 weeks
Hive severity score used for 7 consecutive days (HSS7)
Change from baseline in hive severity score used for 7 consecutive days(HSS7) at weeks 4, 8, 12, 16, 24, 32.Score 0-21, HSS7=0 for complete remission of hives
Measured: Baseline through 32 weeks
Angioedema activity score used for 7 consecutive days(AAS7)
Change from baseline in angioedema activity score used for 7 consecutive days(AAS7) at weeks 4, 8, 12, 16, 24, 32.Score 0-105, higher scores mean a worse outcome
Measured: Baseline through 32 weeks
Urticaria activity score used for 7 consecutive days(UAS7)
Proportion of subjects with UAS7=0 at weeks 4, 8, 12, 16, 24, 32.Score 0-42, UAS7=0 for complete remission
Measured: Baseline through 32 weeks
Dermatology Life Quality Index(DLQI)
Change from baseline in Dermatological Life Quality Index (DLQI) at weeks 4, 8, 12, 16, 24 and 32.Score 0-30, higher scores mean a worse outcome
Measured: Baseline through 32 weeks
Safety and tolerability
Adverse events (AEs) and serious adverse events (SAEs)
Measured: Baseline through 32 weeks
Trends in serum total immunoglobulin E(IgE)
Serum total IgE levels at weeks 4, 8, 12, 16, 24 and 32
Measured: Baseline through 32 weeks
Positive detection rate of anti-drug antibody (ADA)
ADA positive detection rate at 32 weeks
Measured: Baseline through 32 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start4 Aug 2024
- Primary completion15 Jul 2026 (estimated)
- Study completion15 Jul 2026 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jemincare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06509334
- Sponsor's protocol ID
- JYB1904-202
- Status last verified
- Nov 2024
- First submitted
- 27 Jun 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Parallel-group, Active-controlled Phase II Clinical Study to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Adult Patients with Chronic Spontaneous Urticaria Inadequately Controlled by H1 Antihistamines
- ClinicalTrials.gov ID
- NCT06509334
- Acronym / sponsor ID
- JYB1904-202
- Conditions
- Chronic Spontaneous Urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- JemincareIndustry (pharma, biotech, devices)
- Study start
- 4 Aug 2024 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 15 Jul 2026 (estimated)
- First posted
- 19 Jul 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 II Trial is Meant to Evaluate the Efficacy, Safety and Tolerability of JYB1904 Injection in Patients With Chronic Spontaneous Urticaria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| JYB1904: Dose-1 | Experimental | Drug: JYB1904 |
| JYB1904: Dose-2 | Experimental | Drug: JYB1904 |
| Omalizumab | Active comparator | Drug: Omalizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female adult subjects (≥18 years of age).
- Diagnosis of Chronic Spontaneous Urticaria(CSU) ≥ 3 months prior to Screening Visit 1 and previously inadequately controlled with a second-generation H1 antihistamine.
- Itching and hives lasting ≥ 6 weeks prior to Screening Visit 1.
- Have a UAS7 (range 0 - 42) ≥ 16, an ISS7 (range 0 - 21) ≥ 6, and an HSS7 (range 0 - 21) ≥ 6 within 7 days prior to randomization.
Key exclusion criteria (5 listed)
- Induced urticaria with a defined trigger, including artificial urticaria (cutaneous scratches), cold-contact, heat-contact, solar, pressure, delayed-pressure, water-source, cholinergic, or contact urticaria
- Any other dermatological condition with chronic itching, such as atopic dermatitis, herpetic pemphigoid, herpetic dermatitis, senile itching, or psoriasis, which in the opinion of the investigator may affect the study assessment and study results
- Other conditions with symptoms of urticaria or angioedema, including but not limited to urticarial vasculitis, pigmented urticaria, erythema multiforme, mastocytosis, hereditary urticaria, or acquired/drug-induced urticaria.
- Previous allergic reaction or poor efficacy with omalizumab.
- Contraindication or hypersensitivity to antihistamines (e.g., fexofenadine, loratadine, desloratadine, cetirizine, levocetirizine, rupatadine, bilastine) or any of the ingredients.
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 at week0 and receive placebo at week4,8,12 | Drug | JYB1904: Dose-1 |
| JYB1904Participants will receive JYB1904 at week0,8 and receive placebo at week4,12 | Drug | JYB1904: Dose-2 |
| OmalizumabParticipants will receive Omalizumab every 4 weeks for 12 weeks | Drug | Omalizumab |
Primary outcome
Urticaria activity score used for 7 consecutive days(UAS7)
Time frame: Baseline through 16 weeks
Change from baseline in urticaria activity score used for 7 consecutive days (UAS7) at weeks 8, 12, and 16.Score 0-42, UAS7=0 for complete remission
9 secondary outcomes
Urticaria activity score used for 7 consecutive days(UAS7)
Time frame: Baseline through 32 weeks
Itch severity score used for 7 consecutive days(ISS7)
Time frame: Baseline through 32 weeks
Hive severity score used for 7 consecutive days (HSS7)
Time frame: Baseline through 32 weeks
Angioedema activity score used for 7 consecutive days(AAS7)
Time frame: Baseline through 32 weeks
Urticaria activity score used for 7 consecutive days(UAS7)
Time frame: Baseline through 32 weeks
Dermatology Life Quality Index(DLQI)
Time frame: Baseline through 32 weeks
Safety and tolerability
Time frame: Baseline through 32 weeks
Trends in serum total immunoglobulin E(IgE)
Time frame: Baseline through 32 weeks
Positive detection rate of anti-drug antibody (ADA)
Time frame: Baseline through 32 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 29 Nov 2024.
- 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.
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 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 4 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 29 Nov 2024. 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?
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 Yila Sha (86-021-52887926, shayila@jemincare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urticaria activity score used for 7 consecutive days(UAS7) (time frame: Baseline through 16 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 29 Nov 2024.