Acne
Conditions
Interventions
Intervention Group:The subjects received hb0043300mg for injection from W0, and were administered subcutaneously once every two weeks (q2w). The last administration was at W14, and the last visit was
Control Group:The subjects received placebo from W0 by subcutaneous injection at a frequency of Q2W. Starting from W8, HB0043 for injection, 300mg, was administered
Sponsors
Shandong Provincial Institute of Dermatology and Venereology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.. Understand the procedures of this research and voluntarily sign the informed Consent Form (ICF) in person; 2. Male or female individuals aged 18 or above at the time of signing the ICF; 3. The subjects have moderate to severe facial acne vulgaris and meet the following criteria: (1). The lesion may involve at least the face and other parts of the body; (2). Meeting the criteria for moderate to severe acne: the number of inflammatory nodules is >=5, accompanied by cysts or sinus tracts; (3).igga score: 4 points; 4.During the research period, the subjects must avoid using other methods for treating acne; 5. From the date of signing the ICF to within 3 months after the last administration, the subjects and their partners had no plans for having children and voluntarily adopted effective contraceptive measures;
Exclusion criteria
Exclusion criteria: 1. Those who are allergic to HB0043 or any of its components, or are allergic to biological agents, or have had severe drug allergic reactions in the past; 2. Excessive facial hair, or facial skin damage or abnormalities in the subjects may affect the diagnosis or assessment of acne vulgaris; 3. The subject has any facial skin disease other than acne vulgaris; 4. At the time of screening, the subjects had active autoimmune diseases, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, uveitis, etc; 5. Any other active skin diseases or symptoms that may affect the assessment of acne were present during the screening process; 6. There was a history of lymphoproliferative disorders or any known malignant tumors within the five years prior to screening (except for treated and considered cured cutaneous squamous or basal cell carcinoma, cervical carcinoma in situ or ductal carcinoma in situ of the breast); 7. Infection-related exclusion criteria (meeting any one of the following) : (1) Those with a history of chronic or recurrent infections; (2) There is a history of severe life-threatening infections within 6 months prior to screening; (3) Subjects that researchers consider to have a high risk of infection (such as those with leg ulcers, indwelling urinary catheters, persistent or recurrent chest infections, etc.); (4) Infections (excluding the common cold) that require systemic antibiotic treatment within 2 weeks prior to the first administration. 8. Exclusion criteria related to tuberculosis: (1) Those whose medical history, symptoms and relevant examination results suggest active tuberculosis during screening; (2) If the result of the interferon - ? release assay (IGRA) is positive (if the subject has no clinical symptoms related to active tuberculosis and the chest CT examination result during screening is judged by the researcher not to affect the safety of the subject's medication, enrollment is allowed); (3) For those with an IGRA result of uncertain or suspected positive, a re-examination is allowed. If the re-examination still shows a suspected positive or uncertain result and the researcher determines that the chest CT examination result during screening will not affect the safety of the subject's medication, they are allowed to be enrolled. 9. Any of the following cardiovascular and cerebrovascular diseases occurred within the three months prior to screening: (1) Moderate to severe congestive heart failure (New York Heart Association Class III or IV); (2) Unstable angina pectoris, myocardial infarction, coronary artery bypass grafting, and percutaneous coronary intervention (excluding diagnostic angiography) that require hospitalization; (3) Atrial or ventricular arrhythmia requiring hospitalization, pacemaker or defibrillator implantation; (4) Cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack. 10. Subjects who had serious underlying diseases at the time of screening, such as heart, lung, liver, kidney, blood, metabolic, endocrine, digestive, nervous, mental or brain diseases, and were assessed by the researchers as unsuitable to participate in this study; 11. Those with a history of recurrent herpes zoster or herpes simplex within two months prior to screening or in the past; 12. Any of the following abnormal laboratory test results exists during screening or baseline: (1) Blood biochemistry:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Count of inflammatory lesions;Overall Investigator Assessment (IGA) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion (%), nature, correlation and severity of adverse events (TEAE) that occurred during treatment in the subjects;Percentage change in inflammatory lesion count from baseline;Proportion of subjects with IgA score at least 2 points lower than baseline;Proportion of subjects with IgA score of "clearance" or "almost clearance";Changes of acne quality of life relative to baseline;Proportion of subjects with IgA score of "clear" or "almost clear" and at least 2 points lower than baseline IgA score; | — |
Countries
China
Contacts
Public ContactFuren Zhang
Shandong Provincial Institute of Dermatology and Venereology
Outcome results
None listed