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

AbbVie206 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

206

Conditions

Hidradenitis Suppurativa (HS)

Interventions

PlaceboDRUG

Subcutaneous injections administered as described in arm description

AdalimumabDRUG

Subcutaneous injections administered as described in arm description

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (55)

Outcomes

Primary Outcomes

Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12

HiSCR is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline.

Time frame: At Week 12

Secondary Outcomes

Percentage of Participants Achieving HiSCR-es at Week 12

Hidradenitis Suppurativa Clinical Response-es (HiSCR-es) is defined as at least a 50% reduction in the abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to Baseline, excluding the Hidradenitis Suppurativa surgical site.

Time frame: At Week12

Percentage of Participants Achieving HiSCR-es at Week 24

Time frame: At Week 24

Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12

Time frame: From Baseline to Week 12

Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery

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 by the study physician. The change in the surface area of the projected HS surgical site from Baseline to Week 12 was documented, and the percentage of participants at Week 12 requiring a less extensive surgery than the surgical plan (determined at Baseline) or no surgery as determined by the designated surgeon was recorded.

Data from ClinicalTrials.gov

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Wallace Medical Group, Inc. /ID# 171289

Beverly Hills, California, United States

Encino Research Center / T. Jo /ID# 171347

Encino, California, United States

University of California Irvine /ID# 170054

Irvine, California, United States

Tulane Univ /ID# 168441

New Orleans, Louisiana, United States

Beth Israel Deaconess Medical Center /ID# 168438

Boston, Massachusetts, United States

University of Michigan Hospitals /ID# 200667

Ann Arbor, Michigan, United States

Univ NC Chapel Hill /ID# 168446

Chapel Hill, North Carolina, United States

Penn State Hershey Medical Ctr /ID# 168447

Hershey, Pennsylvania, United States

Rhode Island Hospital /ID# 168439

Providence, Rhode Island, United States

CUB Hospital Erasme /ID# 150907

Brussels, Brussels Capital, Belgium

...and 45 more locations