A Study to Evaluate Efficacy and Safety of HB0043 in Aadult Patients With Moderate to Severe Acne Vulgaris.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HB0043, Placebo.
- Who it may be relevant to
- Registry conditions: Acne Vulgaris. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Safety and Efficacy of HB0043 (Bispecific Antibody Targeting IL-17A and IL-36R) in Adult Patients With Moderate to Severe Acne Vulgaris (AV).
Overview
The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe AV.
Detailed description
The total duration of the study is 18 weeks and consists of: Screening (up to 2 weeks) and Treatment Period (16 weeks).
Interventions
- Drug HB0043
300mg - Drug Placebo
300mg
Primary outcome measures
- Change in inflammatory lesion counts [Time frame: Week 16]
- Investigator's global assessment (IGA) - change from Baseline [Time frame: Week 16]
Secondary outcome measures (5)
- Investigator's global assessment (IGA) - percentage of subjects with improvement [Time frame: Week 2, 4, 8, 12, 16]
- Change in inflammatory lesion counts [Time frame: Week 16]
- Investigator's global assessment (IGA) - percentage of subjects with improvement [Time frame: Week 2, 4, 8, 12, 16]
- Investigator's global assessment (IGA) - percentage of subjects with improvement [Time frame: Week 2, 4, 8, 12, 16]
- Incidence of AEs and serious adverse events (SAEs)) [Time frame: Baseline to week 16]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Dermatology Hospital affiliated to Shandong First Medical University, — Jinan
Identifiers
NCT: NCT07449156 · HB0043-AV-0-01