Chronic Spontaneous Urticaria
Conditions
Interventions
Test group:HWH486 capsule
Control group:matching placebo capsule
Sponsors
West China Hospital,Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age >= 18,= 6 consecutive weeks prior to screening, despite second generation H1-antihistamine during this period; UAS7(range 0-42) >= 16, HSS7(range 0-21) >= 6 and ISS7(range 0-21) >= 6 during 7 consecutive days prior to randomization;CSU duration>= 6 months prior to screening. 3) Willing and able to complete the Urticaria Participant Daily eDiary (UPDD) for the duration of the study; 4) The completion of the UPDD for 7 consecutive days prior to randomization without any missing data 5) Willing to take background medication and emergency medication according to the study protocol. 6) Written informed consent signed voluntarily by the patient or their legal representatives.
Exclusion criteria
Exclusion criteria: 1) Previous use of HWH486 or other BTK inhibitors; 2) Patients who could not stop taking antiplatelet or anticoagulant drugs during the study; 3) Chronic urticaria was chronic induced urticaria or chronic induced urticaria as a major trigger of urticaria, such as artificial urticaria (symptomatic dermatoscratch), cold, heat, solar, compression, delayed compression, waterborne, cholinergic, or contact urticaria, or other diseases with urticaria symptoms or angioedema symptoms. Including, but not limited to, urticarial vasculitis, urticaria pigmentosa, erythema multiforme, mastocytosis or drug-induced urticaria; 4) Any other skin disease associated with chronic itching that might influence in the investigator's opinion the study evaluations and results, e.g. atopic dermatitis, bullous pemphigoid, dermatitis herpetiformis, senile pruritus or psoriasis 5) With symptoms or signs of progressive or uncontrolled kidney, liver, blood, gastrointestinal, endocrine, lung, heart, neurological, psychiatric, or brain disease, or with a history of gastrointestinal bleeding that is associated with a significant risk of bleeding or coagulopathy, or is clinically significant (such as requiring hospitalization or blood transfusion), or with other chronic medical conditions that are not eligible for participation in this clinical trial, or having a history of malignancy, other than non-metastatic basal cell carcinoma or skin squamous cell carcinoma or carcinoma in situ of the cervix with appropriate treatment and no signs of recurrence; 6) Clinically important laboratory test indicators are abnormal, including: abnormal blood routine: hemoglobin (Hb) = 1.5×ULN, or alanyl aminotransferase (ALT) >= 1.5×ULN, or total bilirubin (TBIL) >= 1.5×ULN; Abnormal renal function: creatinine (Cr) >= 1×ULN; any other laboratory test indicators that researchers think may affect the evaluation of test results; 7) Active and uncontrolled viral and bacterial infections at the time of screening, such as HIV, HBV, HCV, syphilis, tuberculosis, If there is evidence of clinical significance, or if there are any clinical symptoms of bacterial, viral, parasitic or fungal infection requiring treatment; 8) Resting heart rate <60 bpm; 9) Underwent major surgery within 8 weeks prior to screening* or planned surgery during the study; 10) History of dizzy with needles or blood, could not tolerate blood collection by venipuncture, or had difficulty in blood collection; 11) Pregnant or breastfeeding women; having pregnancy plans during the clinical trial and within 1 month after the last dose, and do not want to take medically accepted reliable contraceptive methods; 12) History of allergy to any investigational therapeutic drug or its excipients; 13) History or evidence of alcohol or drug abuse within the six months prior to randomization; 14) Patients who had taken biological agents for CSU, such as omalizumab and ligelizumab, within 4 months before screening; 15) Systemic use of glucocorticoids within 30 days before screening; 16) Use of other immunosuppressive drugs, including but not limited to hydroxychloroquine, methotrexate, cyclosporin A, cyclophosphamide, tacrolimus, mortemycophenolate, tripterygium, and compound glycyrrhizin, within 30 days or 5 half-lives (whichever is older) prior to screening; 17) Use of any Chinese medicine or patent Chinese medicine used for ur
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change of Urticaria activity score(UAS7); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change of Hive Severity Score(HSS) 7;Change of itchy severity score(ISS) 7;Dermatology Life Quality Index(DLQI);Angioedema activity score(AAS);Uicaria control test(UCT);Proportion of subjects using first aid medication;PK parameters; | — |
Countries
China
Contacts
Public ContactJiang Xian, Feng Ping
West China Hospital,Sichuan University
Outcome results
None listed