DETERMINED 1
Brief summary
This study is to evaluate the safety and efficacy of 2 dose levels of an active drug in adult participants with moderate to severe Hidradenitis Suppurativa (HS). This study includes two treatment periods. In Period A, participants are randomized to receive either an active drug dose A, dose B, or placebo. In Period B, participants who received an active drug dose A or placebo during Period A, will receive an active drug dose B. Participants who received an active drug dose B in Period A will remain on that dose in Period B.
Interventional study
- 1
- 2
- 3
- 4
Age:
18 Years and older.
Inclusion Criteria:
- Participant with moderate to severe HS for at least 1 year prior to baseline visit.
- HS lesions present in at least two distinct anatomical areas.
- Draining fistula count of ≤ 20 at Baseline visit.
- Total abscess and inflammatory nodule (AN) count of ≥ 5 at Baseline visit.
- Participants are required to use a daily antiseptic wash on their HS lesions.
- Participant must have a history of inadequate response or intolerance to an adequate
trial of oral antibiotics for treatment of HS.
Exclusion Criteria:
- Participant has a history of active skin disease other than HS that could interfere
with the assessment of HS.
- Participant has active tuberculosis (TB) or concurrent treatment for latent TB or
evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human
immunodeficiency virus (HIV) infection.
- Participant has prior exposure to anti-interleukin-1 (anti-IL-1) treatment within 3
months or 5 half-lives, whichever is longer, prior to baseline.
- Participant has received prescription topical therapies (including topical
antibiotics) within 14 days prior to the Baseline visit.
- Participant has received systemic non-biologic therapies that can also be used to
treat HS within 4 weeks prior to the Baseline visit.
- Participant has received any systemic (including oral) antibiotic treatment within 4
weeks prior to the Baseline visit.
