The purpose of this study is to assess efficacy, safety, pharmacokinetics and immunogenicity of subcutaneous SCT650C in patients with Moderate to Severe Hidradenitis Suppurativa
The participants must be at least 18 years of age at the time of signing the ICF.
Study participants must have a diagnosis of HS based on clinical history and physical examination for at least 6 months prior to the baseline visit; diagnosis must be verifiable through medical notes and documentation.
Study participants must have HS lesions in at least 2 distinct anatomic areas (eg, left and right axilla), 1 of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits.
Study participants must have moderate to severe HS defined as a total of ≥ 5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits.
Study participant has any medical or psychiatric condition could jeopardize or would compromise the study participant's ability to participate in this study as determined by the investigator based on protocol-required assessments.
Study participant has a draining fistula count of > 20 at the Baseline Visit.
Study participant has any other active skin disease or condition (eg, bacterial cellulitis, candida intertrigo, extensive condyloma) that may, in the opinion of the investigator, interfere with the assessment of HS.
Study participant has a diagnosis of sarcoidosis, systemic lupus erythematosus, or active inflammatory bowel disease (IBD).
Parallel
SCT650C
DrugAdministered SC
The percentage of participants achieving HiSCR75 (a 75% reduction from baseline of Hidradenitis Suppurativa Clinical Response [HiSCR]) at Week 16
HiSCR75 is defined as at least a 75 percent (%) reduction from Baseline in the total abscess and inflammatory nodule (AN) count, with no increase from Baseline in abscess or draining fistula count.
The percentage of participants achieving HiSCR50, HiSCR90, and HiSCR100 at specified time points
HiSCR50 is defined as at least a 50% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining fistulas count. HiSCR90 is defined as at least a 90% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining fistulas count. HiSCR100 is defined as at least a 100% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining fistulas count.
The percentage of participants achieving HiSCR75 at specified time points
HiSCR70 is defined as at least a 75% reduction from Baseline in the total AN count, with no increase from Baseline in abscess or draining fistulas count.
The percentage of participants who experience ≥ 1 disease flare at specified time points
Flare is defined as a greater than or equal to (\>=) 25% increase in AN count with an absolute increase in AN count of \>= 2 relative to Baseline.
The change from baseline in the HS-Physician's Global Assessment (HSPGA) at specified time points
The HSPGA is a validated 6-point scale that is used to measure improvement in inflammatory nodules, abscesses, and draining fistulas. This assessment \[clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5)\] is derived based on totals across all affected body regions.
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