Open-label Study of Adalimumab in Japanese Subjects With Hidradenitis Suppurativa

• Status: Completed
• Trial end date: 2019-05-30
• Target enrollment: 0
• Participant gender: All

Summary

This study investigates efficacy, safety and pharmacokinetics of adalimumab in Japanese subjects with moderate to severe hidradenitis suppurativa (HS).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie
• Treatments: Adalimumab

Criteria

Inclusion Criteria:

• Participant must have a diagnosis of HS;

• Participant must have any HS symptom at least 6 months prior to Baseline;

• HS lesions must be present in at least 2 distinct anatomic areas, one of which must be Hurley Stage II or Hurley Stage III;

• Participant must have stable HS for at least 2 months (60 days) prior to Screening and also at the Baseline visit;

• Participant must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit.

Exclusion Criteria:

• Prior treatment with adalimumab or other anti-tumor necrosis factor (TNF) therapy or participation in adalimumab trial;

• Any other active skin lesion or condition that may interfere with assessment of HS;

• Participants received antibiotic treatment for HS within 28 days prior to the Baseline visit other than those allowed per protocol. Participant on permitted oral antibiotic treatment (doxycycline or minocycline only) for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit;

• Participants received prescription topical therapies for the treatment for HS within 14 days prior to the Baseline visit;

• Participants received systemic non-biologic therapies with potential therapeutic impact for HS less than 28 days prior to the Baseline visit;

• Participants received oral concomitant analgesics (non-opioids and opioids) for HS-related pain within 14 days prior to the Baseline visit.