Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically
- Registration Number
- NCT02808975
- Lead Sponsor
- AbbVie
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 206
-
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
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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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo 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 Adalimumab Adalimumab 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
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Achieving HiSCR-es at Week 12 At Week12 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.
Percentage of Participants Achieving HiSCR-es at Week 24 At Week 24 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.
Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12 From Baseline to Week 12 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.
Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery At Week 12 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.
Trial Locations
- Locations (55)
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, Bruxelles-Capitale, Belgium
Scroll for more (45 remaining)Wallace Medical Group, Inc. /ID# 171289🇺🇸Beverly Hills, California, United States