This is a post-approval commitment study to evaluate efficacy, and safety of two dosing regimens of secukinumab (AIN457), 300 mg every four weeks (Q4W) and every two weeks (Q2W), in Chinese adult patients with moderate to severe hidradenitis suppurativa (HS).
Signed informed consent must be obtained before any assessment is performed.
Chinese male and female participants ≥ 18 years of age.
Confirmed/documented diagnosis of HS ≥ 6 months prior to baseline.
A total of at least 5 inflammatory lesions, i.e., abscesses and/or inflammatory nodules AND
Total fistulae count ≥ 20 at baseline.
Any other active skin disease or condition that may interfere with assessment of HS at baseline.
Active inflammatory bowel disease.
Underlying conditions (including, but not limited to, metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious including tuberculosis and hepatitis, or gastrointestinal conditions), which in the opinion of the investigator, significantly immunocompromise the participant and/or place the participant at unacceptable risk for receiving an immunomodulatory therapy.
Parallel
Secukinumab
Drugsecukinumab 300 mg s.c. administered Q2W or Q4W
Percentage of participants achieving HiSCR50 at Week 16
HiSCR50 is defined as at least a 50% decrease in Abscess and Inflammatory Nodule (AN) count with no increase in the number of abscesses and/or in the number of draining fistulae.
Percentage change from baseline in AN Count at Week 16
Percent change from baseline in total Abscess and Inflammatory Nodule (AN) count.
Percentage of participants experiencing an HS Flare through Week 16
Flare is defined as at least a 25% increase in AN count from baseline with a minimum absolute increase of 2 lesions.
Percentage of participants achieving NRS30 Skin Pain Response at Week 16
Among participants with baseline NRS ≥3, NRS30 is defined as ≥30% reduction and ≥2-unit reduction from baseline in Patient's Global Assessment of Skin Pain (worst level).
Percentage of participants achieving HiSCR50 through Week 52
Proportion of participants achieving HiSCR50 (≥50% reduction in AN count with no worsening of abscesses or draining fistulae) with secukinumab 300 mg Q2W or Q4W.
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