Clinical Trials in China / NCT07449156
Starting soon
Phase 1/2
A Study to Evaluate Efficacy and Safety of HB0043 in Aadult Patients With Moderate to Severe Acne Vulgaris.
NCT07449156 · tracked via the Priya Life Science China tracker
Condition(s) studied
Acne Vulgaris
Study summary
The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe AV.
Eligibility
Inclusion Criteria:
\- 1. Understand the research procedure of this study and provide written informed consent; 2. Male or female, age 18 years or greater; 3. Diagnosed with mild to moderate facial acne vulgaris; 4. Throughout the study period, participants must refrain from using concomitant acne therapies.
5\. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including 3 months of follow-up.
Exclusion Criteria:
* 1\. Participants with known hypersensitivity to HB0043 or any of its excipients; 2. Those with facial skin or hair conditions, or with facial skin damage or abnormality that may interfere with clinical assessment.
3\. Participant has any facial skin disease other than common acne. 4. Presence of other active autoimmune diseases, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and uveitis; 5. Participant has any other active skin disease or condition that may interfere with the assessment of acne vulgaris; 6. History of lymphoproliferative disorders or any known malignancy within five years prior to the Screening Visit (excluding treated and cured cutaneous squamous cell carcinoma, basal cell carcinoma, carcinoma uterine in situ, or intraductal breast cancer in situ); 7. History of recurrent or recent serious infection; 8. Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection; 9. Pregnant or lactating women; 10. Any reason why, in the opinion of the investigator, the patient should not participate.
Primary outcome measure(s)
- Change in inflammatory lesion counts — Week 16
Absolute change from Baseline in the number of inflammatory acne lesions - Investigator's global assessment (IGA) - change from Baseline — Week 16
Absolute change in IGA score from Baseline \[scores: 0-4; 0=clear, 4=severe\]
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Dermatology Hospital affiliated to Shandong First Medical University, | Jinan | Shandong |
More Shanghai Huaota Biopharmaceutical Co., Ltd. trials in China
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07449156 on ClinicalTrials.gov ↗ ← All trials in China