Chronic Spontaneous UrticariaPhase 2NCT07613866
A Clinical Trial of HRS-3095 in Patients With Chronic Spontaneous Urticaria
A Phase 2 study testing HRS-3095 Tablet in people with Chronic Spontaneous Urticaria, run by Chengdu Suncadia Medicine Co., Ltd. at 2 sites in China.
Trial summary
The study is being conducted to evaluate the efficacy, and safety of HRS-3095 with Chronic Spontaneous in adults, and to explore the reasonable dosage of HRS-3095 for Chronic Spontaneous Urticaria. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Spontaneous Urticaria
- What is being tested?
- HRS-3095 Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 2 sitesChina
- Study dates
- Jul 2026to Mar 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be between 18 and 70 years of age, inclusive, at the time of signing the Informed Consent Form (ICF), with no restriction on gender.
- Participants must have a history of chronic spontaneous urticaria (CSU) with a disease duration of at least 6 months prior to screening.
- Participants must be diagnosed with H1-antihistamine-inadequately-controlled CSU at screening, defined as: having had persistent symptoms of pruritus and wheals for ≥6 weeks prior to screening, despite regular use of second-generation H1-antihistamines during that period.
- At randomization, the UAS7 score must be ≥16 (range: 0-42) and the HSS7 score ≥ 8 (range: 0-21).
- Participants must have been on a stable dose of the specified second-generation H1-antihistamine for at least 3 days prior to the first UAS score at screening.
- Participants must be willing and able to complete logbook entries as required during the study and must have no missing daily UAS scores during the 7 days before randomization.
- Participants must voluntarily sign the Informed Consent Form (ICF) before any study-related procedures, be able to communicate effectively with the investigator, and be willing to strictly adhere to the requirements of the study protocol.
- Female participants of childbearing potential or male participants with a female partner of childbearing potential must agree to avoid donating sperm or ova and must agree to take highly effective contraceptive measures from the time of signing the ICF until 3 months after the last dose.
Who cannot join
- Any skin disease that could interfere with study assessment (e.g., chronic inducible urticaria, urticarial vasculitis, atopic dermatitis, psoriasis).
- Use of systemic or topical medications with therapeutic or immunomodulatory effects on the study disease during the relevant washout period prior to screening.
- Use of investigational drugs or medical devices within 8 weeks or 5 half-lives (if known), whichever is longer, or within 30 days (for small molecules) prior to screening.
- Vaccination or exposure to live or attenuated vaccines within 3 months prior to screening or participation in a vaccine-related clinical trial within 3 months prior to randomization.
- History or current coagulation-related risk (e.g., bleeding diathesis, coagulopathy, GI bleeding with clinical significance, antiplatelet or anticoagulant use, history of thrombosis or thromboembolic events, or increased risk of thrombosis).
- History of liver disease or current treatment for liver disease (e.g., hepatitis, cirrhosis, liver failure).
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- History of systemic antimicrobial use or presence of superficial skin infection (e.g., impetigo) within 4 weeks prior to screening.
- History of malignancy or current malignancy (excluding completely resected and recurrence-free basal cell carcinoma, squamous cell carcinoma, or cervical intraepithelial neoplasia).
- Major surgery performed within 3 months prior to randomization or planned during the study.
- Serious concomitant disease or any condition judged by the investigator to make the participant unsuitable for study participation.
- Abnormal findings in vital signs, physical examination, laboratory tests, ECG, chest X-ray/CT, or abdominal ultrasound during screening that have clinical significance and may affect study validity or participant safety.
- Pregnant or breastfeeding women.
- Allergy to the study drug or any of its components.
- History of alcohol abuse within 6 months prior to screening (e.g., > 14 units/week) or history of illicit drug abuse within 6 months prior to screening.
- Any condition judged by the investigator that may affect the safety or efficacy evaluation of the study drug or participant compliance with the study procedures or diary.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
Hangzhou, Zhejiang, 310006
Liming Wu, +86-13750837205, 18957118053@163.com
Liming Wu
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
Wenyu Wu, +86-021-52887783, 13601983907@139.com
Wenyu Wu
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of HRS-3095 in Patients With Chronic Spontaneous Urticaria
The study is being conducted to evaluate the efficacy, and safety of HRS-3095 with Chronic Spontaneous in adults, and to explore the reasonable dosage of HRS-3095 for Chronic Spontaneous Urticaria.
- Conditions
- Chronic Spontaneous Urticaria
- Being tested
- HRS-3095 Tablet, HRS-3095 Tablet Placebo
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-3095 TabletDrug
HRS-3095 tablet.
HRS-3095 Tablet PlaceboDrug
HRS-3095 tablet placebo.
| Study group | Role | What they receive |
|---|---|---|
| HRS-3095 Group | Experimental | HRS-3095 in different doses. Receives: Drug: HRS-3095 Tablet |
| HRS-3095 placebo Group | Placebo comparator | HRS-3095 blank preparation. Receives: Drug: HRS-3095 Tablet Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 4.
Measured: Up to 4 weeks.
Secondary outcomes (23)
The concentration of HRS-3095 in serum (Cmax)
Measured: From the beginning of administration to the 4th week.
The time of metabolism of the drug in the serum
The concentration of HRS-3095 in plasma will be determined.
Measured: From the beginning of administration to the 4th week.
The concentration of HRS-3095 in serum (AUC)
The concentration of HRS-3095 in plasma will be determined.
Measured: From the beginning of administration to the 4th week.
Change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 2
Measured: Up to 4 weeks.
Change in Weekly Itch Severity Score (ISS7) from baseline at Week 2 and 4
Measured: Up to 4 weeks.
Change in Weekly Wheal Severity Score (HSS7) from baseline at Week 2 and 4
Measured: Up to 4 weeks.
Percentage change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 2 and 4
Measured: Up to 4 weeks.
Percentage change in Weekly Itch Severity Score (ISS7) from baseline at Week 2 and 4
Measured: Up to 4 weeks.
Percentage change in Weekly Wheal Severity Score (HSS7) from baseline at Week 2 and 4
Measured: Up to 4 weeks.
Proportion of patients with UAS7 ≤ 6 at Week 2 and 4 compared to baseline
Measured: Up to 4 weeks.
Proportion of patients with UAS7 = 0 at Week 2 and 4 compared to baseline
Measured: Up to 4 weeks.
Proportion of patients achieving the Minimum Important Difference (MID) in UAS7 at Week 2 and 4
≥ 10-point decrease from baseline.
Measured: Up to 4 weeks.
Proportion of patients achieving the Minimum Important Difference (MID) in ISS7 at Week 2 and 4
≥ 5-point decrease from baseline.
Measured: Up to 4 weeks.
Time to achieve the Minimum Important Difference (MID) in UAS7
≥ 10-point decrease from baseline.
Measured: Up to 4 weeks.
Time to achieve the Minimum Important Difference (MID) in ISS7
≥ 10-point decrease from baseline.
Measured: Up to 4 weeks.
Change in 7-day Angioedema Activity Score (AAS7) from baseline at Week 2 and 4
Measured: Up to 4 weeks.
Change in Urticaria Control Test (UCT) from baseline at Week 4
Measured: Up to 4 weeks.
Proportion of participants with UCT ≥ 12 at Week 4 compared to baseline
Measured: Up to 4 weeks.
Change in Dermatology Life Quality Index (DLQI) from baseline at Week 4
Measured: Up to 4 weeks.
Proportion of participants with DLQI = 0 or 1 at Week 4 compared to baseline
Measured: Up to 4 weeks.
Adverse events
Measured: From the beginning of administration to the 8th week.
Plasma concentrations of HRS-3095 and its metabolites
Measured: From the beginning of administration to the 4th week.
Relative change from baseline in serum total immunoglobulin E (IgE)
Measured: From the beginning of administration to the 4th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (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.
- 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
- Model description
- HRS-3095 compared with placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07613866
- Sponsor's protocol ID
- HRS-3095-201
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of HRS-3095 in Patients With Chronic Spontaneous Urticaria
- ClinicalTrials.gov ID
- NCT07613866
- Acronym / sponsor ID
- HRS-3095-201
- Conditions
- Chronic Spontaneous Urticaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 29 May 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.
The study is being conducted to evaluate the efficacy, and safety of HRS-3095 with Chronic Spontaneous in adults, and to explore the reasonable dosage of HRS-3095 for 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
- 2
- Model description
- HRS-3095 compared with placebo.
| Arm | Type | Receives |
|---|---|---|
| HRS-3095 Group | Experimental | Drug: HRS-3095 TabletHRS-3095 in different doses. |
| HRS-3095 placebo Group | Placebo comparator | Drug: HRS-3095 Tablet PlaceboHRS-3095 blank preparation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants must be between 18 and 70 years of age, inclusive, at the time of signing the Informed Consent Form (ICF), with no restriction on gender.
- Participants must have a history of chronic spontaneous urticaria (CSU) with a disease duration of at least 6 months prior to screening.
- Participants must be diagnosed with H1-antihistamine-inadequately-controlled CSU at screening, defined as: having had persistent symptoms of pruritus and wheals for ≥6 weeks prior to screening, despite regular use of second-generation H1-antihistamines during that period.
- At randomization, the UAS7 score must be ≥16 (range: 0-42) and the HSS7 score ≥ 8 (range: 0-21).
- Participants must have been on a stable dose of the specified second-generation H1-antihistamine for at least 3 days prior to the first UAS score at screening.
Key exclusion criteria (15 listed)
- Any skin disease that could interfere with study assessment (e.g., chronic inducible urticaria, urticarial vasculitis, atopic dermatitis, psoriasis).
- Use of systemic or topical medications with therapeutic or immunomodulatory effects on the study disease during the relevant washout period prior to screening.
- Use of investigational drugs or medical devices within 8 weeks or 5 half-lives (if known), whichever is longer, or within 30 days (for small molecules) prior to screening.
- Vaccination or exposure to live or attenuated vaccines within 3 months prior to screening or participation in a vaccine-related clinical trial within 3 months prior to randomization.
- History or current coagulation-related risk (e.g., bleeding diathesis, coagulopathy, GI bleeding with clinical significance, antiplatelet or anticoagulant use, history of thrombosis or thromboembolic events, or increased risk of thrombosis).
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 |
|---|---|---|
| HRS-3095 TabletHRS-3095 tablet. | Drug | HRS-3095 Group |
| HRS-3095 Tablet PlaceboHRS-3095 tablet placebo. | Drug | HRS-3095 placebo Group |
Primary outcome
Change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 4.
Time frame: Up to 4 weeks.
23 secondary outcomes
The concentration of HRS-3095 in serum (Cmax)
Time frame: From the beginning of administration to the 4th week.
The time of metabolism of the drug in the serum
Time frame: From the beginning of administration to the 4th week.
The concentration of HRS-3095 in serum (AUC)
Time frame: From the beginning of administration to the 4th week.
Change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 2
Time frame: Up to 4 weeks.
Change in Weekly Itch Severity Score (ISS7) from baseline at Week 2 and 4
Time frame: Up to 4 weeks.
Change in Weekly Wheal Severity Score (HSS7) from baseline at Week 2 and 4
Time frame: Up to 4 weeks.
Percentage change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 2 and 4
Time frame: Up to 4 weeks.
Percentage change in Weekly Itch Severity Score (ISS7) from baseline at Week 2 and 4
Time frame: Up to 4 weeks.
Percentage change in Weekly Wheal Severity Score (HSS7) from baseline at Week 2 and 4
Time frame: Up to 4 weeks.
Proportion of patients with UAS7 ≤ 6 at Week 2 and 4 compared to baseline
Time frame: Up to 4 weeks.
Proportion of patients with UAS7 = 0 at Week 2 and 4 compared to baseline
Time frame: Up to 4 weeks.
Proportion of patients achieving the Minimum Important Difference (MID) in UAS7 at Week 2 and 4
Time frame: Up to 4 weeks.
Proportion of patients achieving the Minimum Important Difference (MID) in ISS7 at Week 2 and 4
Time frame: Up to 4 weeks.
Time to achieve the Minimum Important Difference (MID) in UAS7
Time frame: Up to 4 weeks.
Time to achieve the Minimum Important Difference (MID) in ISS7
Time frame: Up to 4 weeks.
Change in 7-day Angioedema Activity Score (AAS7) from baseline at Week 2 and 4
Time frame: Up to 4 weeks.
Change in Urticaria Control Test (UCT) from baseline at Week 4
Time frame: Up to 4 weeks.
Proportion of participants with UCT ≥ 12 at Week 4 compared to baseline
Time frame: Up to 4 weeks.
Change in Dermatology Life Quality Index (DLQI) from baseline at Week 4
Time frame: Up to 4 weeks.
Proportion of participants with DLQI = 0 or 1 at Week 4 compared to baseline
Time frame: Up to 4 weeks.
Adverse events
Time frame: From the beginning of administration to the 8th week.
Plasma concentrations of HRS-3095 and its metabolites
Time frame: From the beginning of administration to the 4th week.
Relative change from baseline in serum total immunoglobulin E (IgE)
Time frame: From the beginning of administration to the 4th week.
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 May 2026.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HRS-3095 Tablet in people with Chronic Spontaneous Urticaria, run by Chengdu Suncadia Medicine Co., Ltd. at 2 sites 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 8 inclusion and 15 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: opening soon, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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 Yijia Xu (+86-0518-81220121, yijia.xu@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Weekly Urticaria Activity Score (UAS7) from baseline at Week 4. (time frame: Up to 4 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 May 2026.