A Study to Assess Disease Activity and Safety of Lutikizumab in Adult and Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa
Phase 3
1,280
about 2.5 years
12+
73 sites in AL, AR, AZ +24
What this study is about
Researchers are testing whether lutikizumab, a new medication, is better than placebo for treating moderate to severe hidradenitis suppurativa (HS) in adults and adolescents. The trial will last about 917 days and involve around 1280 participants at sites worldwide. Participants will receive either lutikizumab or placebo through injections every week or every other week, with some receiving the medication for a longer period.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Take Lutikizumab
- 2.Take Placebo
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
You may get a placebo/standard care, and you won't know which.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
monoclonal antibody
Primary: Number of Participants with Adverse Events (AEs)
Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) among participants ≥ 16 years of age at Baseline, Change from Baseline in HSIA Mobility Domain, Change from Baseline in HSSA, Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA), Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA) Emotional Domain, Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA) Worst Drainage Score, Change from Baseline in number of Draining Fistulas Count among participants with at least 1 draining fistula at Baseline, Change from Baseline in the Patient's Global Assessment of HS-related Odor (smell), based on the HSSA Question 8