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

AbbVie

Status and phase: Completed; Phase 4

Conditions: Hidradenitis Suppurativa (HS)

Treatments: Drug: Adalimumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02808975

2015-005161-23 (EudraCT Number)

M15-574

Details and patient eligibility

About

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.

Full 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.

Enrollment: 206 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant must have skin lesions that are diagnostic of Hidradenitis Suppurativa (HS) for at least 1 year (365 days) prior to the Baseline visit

• Participant must have at least 3 distinct anatomical regions involved with inflammatory (also termed 'active') HS lesions; plus

  • either one axilla or one inguinal region (limited to the inguino-crural fold and adjacent areas) that requires excisional surgery, and
  • with at least one of the other affected HS regions (e.g., contralateral inguinal region, buttocks, inframammary region) rated as Hurley Stage II or III

• Participant must have a total abscess and inflammatory nodule (AN) count of greater than or equal to 3 at the Baseline visit within the HS non-surgical sites

• The HS surgical site must contain at least one active HS lesion

• The HS surgical site must require excisional surgery and is large enough to require healing by secondary intention as assessed by the designated surgeon

Exclusion criteria

• Participant has a draining fistula count of greater than 20 at the Baseline visit
• Participant requires surgery at any anatomical site other than an unilateral axilla or inguinal region site
• Participant requires surgical management prior to Week 13
• Participant requires, based on the designated surgeon's assessment, excisional surgery with primary closure as the method of closure being most beneficial for the participant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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206 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Period A: Day 1- 4 subcutaneous (SC) injections; Week 2- 2 SC injections; Weeks 4-12- 1 SC injection each week Period B: Weeks 13-14- 1 SC injection each week Period C: Weeks 15-23- 1 SC injection each week

Treatment:

Drug: Placebo

Adalimumab

Active Comparator group

Description:

Period A: Day 1- 4 subcutaneous (SC) 40 mg injections; Week 2- 2 SC 40 mg injections; Weeks 4-12- 1 SC 40 mg injection each week Period B: Weeks 13-14- 1 SC 40 mg injection each week Period C: Weeks 15-23- 1 SC 40 mg injection each week

Treatment:

Drug: Adalimumab