Hidradenitis suppurativa
Conditions
Interventions
In Period 1, participants will receive subcutaneous injections of lutikizumab or placebo every week for 16 weeks. In Period 2, participants that were randomized to lutikizumab in Period 1 will receive
Sponsors
Otani Tetsuya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Diagnosis of moderate to severe HS for at least 6 months prior to Baseline as determined by the investigator (i.e., through medical history and interview of participant). - Total abscess and inflammatory nodule (AN) count of >= 5 at Baseline - Hidradenitis suppurativa (HS) lesions present in at least two distinct anatomic areas at Baseline. - At least 1 anatomic area of HS involvement characterized as Hurley Stage II or higher at Baseline.
Exclusion criteria
Exclusion criteria: - Any evidence of Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. - Confirmed positive anti-HIV antibody (HIV Ab) test. - Evidence of active tuberculosis or meets tuberculosis exclusionary parameter
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Percentage of Participants Achieving Hidradenitis Suppurative Clinical Response (HiSCR) 75 (Time frame: Week 16) - Number of Participants with Adverse Events (AEs) (Time frame: Up to Approximately Week 62) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Percentage of Participants Achieving Numeric Rating Scale (NRS) 30 among Participants with Baseline NRS >=3 (Time frame: Week 8) - Change from Baseline in Dermatology Life Quality Index (DLQI) (Time frame: Week 16) - Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) (Time frame: Week 16) - Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) Worst Drainage Score (Time frame: Week 16) - Change from Baseline in Draining Fistula Count (Time frame: Week 16) - Percentage of Participants Achieving HiSCR 90 (Time frame: Week 16) - Change from Baseline in the Patient's Global Assessment of HS-related Skin Pain (NRS) (Time frame: Week 8) - Change from Baseline in HSSA (Time frame: Week 16) - Change from Baseline in the Patient's Global Assessment of HS-related Odor (smell), based on the HSSA Question 8 (Time frame: Week 16) - Percentage of Participants with an Occurrence of HS Flare in Period 1 (Time frame: Baseline to Week 16) | — |
Countries
Japan, Puerto Rico, the United States of America
Contacts
Public ContactContact for Patients and HCP
AbbVie GK
Outcome results
None listed