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NCT Number: NCT07449156

A Study to Evaluate Efficacy and Safety of HB0043 in Aadult Patients With Moderate to Severe Acne Vulgaris.

The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe AV.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

About this study

The total duration of the study is 18 weeks and consists of: Screening (up to 2 weeks) and Treatment Period (16 weeks).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • 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.

Treatment and study plan

HB0043

Drug

300mg

Placebo

Drug

300mg

Primary outcomes

  1. Change in inflammatory lesion counts

    Time frame: Week 16

    Absolute change from Baseline in the number of inflammatory acne lesions

  2. Investigator's global assessment (IGA) - change from Baseline

    Time frame: Week 16

    Absolute change in IGA score from Baseline [scores: 0-4; 0=clear, 4=severe]

Secondary outcomes

  1. Investigator's global assessment (IGA) - percentage of subjects with improvement

    Time frame: Week 2, 4, 8, 12, 16

    Percentage of subjects with at least two-grade improvement in their Baseline IGA score (assessment of mild, clear or almost clear) [scores: 0-4; 0=clear, 4=severe]

  2. Change in inflammatory lesion counts

    Time frame: Week 16

    Percentage change from Baseline in the number of inflammatory acne lesions

  3. Investigator's global assessment (IGA) - percentage of subjects with improvement

    Time frame: Week 2, 4, 8, 12, 16

    Percentage of subjects with an IGA score of "clear" or "almost clear"

  4. Investigator's global assessment (IGA) - percentage of subjects with improvement

    Time frame: Week 2, 4, 8, 12, 16

    Percentage of subjects with an IGA score of "clear" or "almost clear" and a reduction of at least two-grade compared to the baseline IGA score.

  5. Incidence of AEs and serious adverse events (SAEs))

    Time frame: Baseline to week 16

    Incidence of AEs and SAEs

Sponsors and collaborators

Lead sponsor

Shanghai Huaota Biopharmaceutical Co., Ltd.

Industry

Collaborators

  • Dermatology Hospital affiliated to Shandong First Medical University

Registry information

Official study 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).

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 4, 2026
Registry last updated
Mar 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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