Hidradenitis suppurativa
Conditions
Brief summary
Time to loss of response up to Week 104 (Randomized Withdrawal period) in subjects who were HiSCR responders at Week 52 in the core studies. HiSCR response is defined as at least 50% decrease in Abscess and inflammatory Nodule (AN) number relative to the Baseline visit in the core study, with no increase in the number of abscesses and in the number of draining fistulae. Loss of response is defined as: • at least a 50% or greater increase in AN count (abscess and/or nodules) at a regular or unsch
Detailed description
Adverse events, laboratory values, vital signs
Interventions
DRUGSECUKINUMAB
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to loss of response up to Week 104 (Randomized Withdrawal period) in subjects who were HiSCR responders at Week 52 in the core studies. HiSCR response is defined as at least 50% decrease in Abscess and inflammatory Nodule (AN) number relative to the Baseline visit in the core study, with no increase in the number of abscesses and in the number of draining fistulae. Loss of response is defined as: • at least a 50% or greater increase in AN count (abscess and/or nodules) at a regular or unsch | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse events, laboratory values, vital signs | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, Greece, Hungary, Italy, Lithuania, Netherlands, Poland, Portugal, Slovakia, Spain
Outcome results
None listed