The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS.
HS lesions in at least 2 distinct anatomic area;
One of the HS lesions must be Hurley Stage II or Hurley Stage III;
Total abscess and inflammatory nodule (AN) count of greater than or equal to 3; 5. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including six months of follow-up.
1. Participants with known hypersensitivity to HB0043 or any of its excipients; 2. Participant has a draining fistula count of ≥20 at the Screening Visit; 3. Presence of other active autoimmune diseases except HS, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and uveitis; 4. Participant has any other active skin disease or condition that may interfere with the assessment of hidradenitis suppurativa; 5. 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); 6. History of recurrent or recent serious infection; 7. 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; 8. Pregnant or lactating women; 9. Any reason why, in the opinion of the investigator, the patient should not participate.
Crossover
HB0043
DrugLow dose
HB0043
DrugMedium dose
HB0043
DrugHigh dose
Safety and Tolerability of HB0043 in Patients with Moderate to Severe HS
The incidence rate, characteristics, relevance, and severity of treatment-emergent adverse events (TEAEs) experienced by subjects during the treatment period.
Percentage of participants achieving HiSCR
Percentage of participants achieving HiSCR at Week 12 was reported. For this score participants were defined as achievers or non-achievers. The positive HiSCR score was defined as a greater than or equal to (\>=) 50% reduction in inflammatory lesion AN count (sum of abscesses and inflammatory nodules), and no increase in abscesses or draining fistulas in hidradenitis suppurativa compared with the lesions counted on visit 1 (baseline).
Change From Baseline in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count
The sum of abscesses and inflammatory nodules was measured for each participant to assess change in inflammatory lesion counts.
Change From Baseline in the number of lesions
The number of lesions refers to the total sum of abscesses, iInflammatory nodules, and draining fistulas count.
Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA-NRS
PGA-NRS is evaluated based on worst skin pain in a 24-hour recall period (maximal daily pain), ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). The percentage of participants who achieved at least 30% reduction and at least 1 unit reduction from Baseline in the PGA-NRS.
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Shanghai Huaota Biopharmaceutical Co., Ltd.
Lead sponsor
Dermatology Hospital affiliated to Shandong First Medical University
Collaborator
