Dermatology Hospital affiliated to Shandong First Medical University,
Jinan, Shandong, China
NCT Number: NCT07449156
The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe AV.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 1 / Phase 2
Jinan, Shandong, China
The total duration of the study is 18 weeks and consists of: Screening (up to 2 weeks) and Treatment Period (16 weeks).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
300mg
300mg
Time frame: Week 16
Absolute change from Baseline in the number of inflammatory acne lesions
Time frame: Week 16
Absolute change in IGA score from Baseline [scores: 0-4; 0=clear, 4=severe]
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]
Time frame: Week 16
Percentage change from Baseline in the number of inflammatory acne lesions
Time frame: Week 2, 4, 8, 12, 16
Percentage of subjects with an IGA score of "clear" or "almost clear"
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.
Time frame: Baseline to week 16
Incidence of AEs and SAEs
Shanghai Huaota Biopharmaceutical Co., Ltd.
Industry
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).
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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