NCT02808975

Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically

A Phase 4, Double-blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety and Efficacy of Adalimumab Used in Conjunction With Surgery in Subjects With Moderate to Severe Hidradenitis Suppurativa

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study was to assess the safety and efficacy of adalimumab prior to surgery in participants with moderate to severe Hidradenitis Suppurativa (HS) who were surgical candidates.

Detailed description

This was an interventional, randomized, double-blind (DB), placebo-controlled study. The study duration included a 30-day Screening Period, an initial 12-week DB treatment pre-surgery period (Period A), a 2-week peri-operative period with continuation of weekly DB study drug administration (Period B), and a subsequent 10-week DB treatment post-operative period (Period C). Randomization (in a 1:1 ratio) in Period A was stratified by baseline Hurley Stage (II versus III) and anatomical location of the planned surgical site (i.e., axilla versus inguinal region). The projected size of the surgical excision established by the designated surgeon during the Screening Period (calculated from a tracing of the outer perimeter onto an acetate sheet or equivalent) was recorded. In Period B, the designated surgeon measured and recorded the surface area of the actual surgery, with surgery occurring during Week 13. Surgery and post-operative management (e.g., hospitalization, surgical wound care) was per local practice. No study drug was administered at Week 24, the final study visit. Participants were able to begin commercial product (as prescribed by the participants's physician) after all Week 24 procedures were completed.

Conditions

• Hidradenitis Suppurativa (HS)

Interventions

Type	Name	Description
DRUG	Placebo	Subcutaneous injections administered as described in arm description
DRUG	Adalimumab	Subcutaneous injections administered as described in arm description

Timeline

• Start date: 2016-07-18
• Primary completion: 2019-05-16
• Completion: 2019-10-16
• First posted: 2016-06-22
• Last updated: 2020-05-14
• Results posted: 2020-05-14

Locations

55 sites across 23 countries: United States, Belgium, Canada, Colombia, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Spain, Sweden, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study