hidradenitis suppurativa (HS)
Conditions
Brief summary
Percentage of participants achieving HiSCR75 at Week 16
Detailed description
Treatment-emergent adverse event (TEAEs), Serious adverse event (SAEs), TEAEs leading to study withdrawal, Adverse event of special interest (AESIs), Physical examinations, vital signs, and ECG results, Abnormal laboratory parameters (hematology, clinical chemistry, urinalysis), 1. Percentage of participants achieving HiSCR50 at Week 16, 2. Percentage of participants achieving IHS4-55 at Week 16, 5. Percentage of participants achieving a DLQI total reduction of ≥4 (minimal clinically important difference) at Week 16 among participants with a baseline DLQI ≥4, 3. Percentage of participants achieving a ≥3-unit reduction at Week 16 in the NRS for skin pain in PGA among participants with a baseline NRS ≥3, 4. Absolute change in HiSQOL score at Week 16
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of participants achieving HiSCR75 at Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment-emergent adverse event (TEAEs), Serious adverse event (SAEs), TEAEs leading to study withdrawal, Adverse event of special interest (AESIs), Physical examinations, vital signs, and ECG results, Abnormal laboratory parameters (hematology, clinical chemistry, urinalysis), 1. Percentage of participants achieving HiSCR50 at Week 16, 2. Percentage of participants achieving IHS4-55 at Week 16, 5. Percentage of participants achieving a DLQI total reduction of ≥4 (minimal clinically important difference) at Week 16 among participants with a baseline DLQI ≥4, 3. Percentage of participants achieving a ≥3-unit reduction at Week 16 in the NRS for skin pain in PGA among participants with a baseline NRS ≥3, 4. Absolute change in HiSQOL score at Week 16 | — |
Countries
Belgium, Bulgaria, Czechia, France, Germany, Ireland, Netherlands, Poland, Slovakia, Spain