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

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

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.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa (HS)
• Intervention / Treatment: Drug: Placebo; Drug: Adalimumab

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.

• Study Type: Interventional
• Enrollment (Actual): 206
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles-Capitale
    • Brussels, Bruxelles-Capitale, Belgium, 1070
      • CUB Hospital Erasme /ID# 150907
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • UZ Gent /ID# 150906
• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1C 2H5
      • NewLab Clinical Research Inc. /ID# 151315
  • Ontario
    • Richmond Hill, Ontario, Canada, L4C 9M7
      • York Dermatology Clinic and Research Centre /ID# 151314
• Colombia
  • Cali, Colombia, 760032
    • Fundacion Valle Del Lili /ID# 151565
  • Medellín, Colombia
    • Hospital Pablo Tobon Uribe /ID# 152693
• Czechia
  • Prague, Czechia, 100 34
    • Fakult Nem Kralovske Vinohrady /ID# 169173
  • Praha 5
    • Ostrava, Praha 5, Czechia, 708 52
      • Fakultni nemocnice Ostrava /ID# 169174
• Denmark
  • Hovedstaden
    • Copenhagen NV, Hovedstaden, Denmark, 2400
      • Bispebjerg Hospital /ID# 150796
  • Sjælland
    • Roskilde, Sjælland, Denmark, 4000
      • Sjaellands Universitets Hospit /ID# 150795
• France
  • Reims, France, 51100
    • Polyclinique Courlancy /ID# 157761
  • Ile-de-France
    • Antony, Ile-de-France, France, 92160
      • Hopital Prive d'Antony /ID# 157347
• Germany
  • Berlin, Germany, 10117
    • Charité Universitätsmedizin Campus Mitte /ID# 150875
  • Bochum, Germany, 44791
    • Klinikum Ruhr Univ Bochum /ID# 150873
  • Darmstadt, Germany, 64297
    • Klinikum Darmstadt GmbH /ID# 150874
  • Dessau, Germany, 06847
    • Staedtisches Klinikum Dessau /ID# 150876
  • Bayern
    • Erlangen, Bayern, Germany, 91054
      • Universitaetsklinikum Erlangen /ID# 167251
• Greece
  • Athens, Greece, 16121
    • Genl Hospital Andreas Syggros /ID# 150840
  • Athens, Greece, 16121
    • Genl Hospital Andreas Syggros /ID# 150842
  • Attiki
    • Athens, Attiki, Greece, 12462
      • University General Hospital Attikon /ID# 150841
• Ireland
  • Dublin, Ireland, D04 T6F4
    • St Vincent's University Hosp /ID# 150043
• Italy
  • Ferrara, Italy, 44124
    • A.O.U Sant'Anna di Ferrara /ID# 150066
  • Modena, Italy, 41124
    • Universita degli Studi di /ID# 150068
  • Rome, Italy, 00133
    • Policlinico Univ Tor Vergata /ID# 150142
  • Lombardia
    • Milan, Lombardia, Italy, 20122
      • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150069
• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64460
      • Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 151027
• Netherlands
  • Groningen, Netherlands, 9713 GZ
    • Universitair Medisch Centrum Groningen /ID# 150662
  • Rotterdam, Netherlands, 3015 CE
    • Erasmus Medisch Centrum /ID# 150672
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525 GA
      • Radboud Universitair Medisch Centrum /ID# 152157
• Norway
  • Hordaland
    • Bergen, Hordaland, Norway, 5021
      • Haukeland University Hospital /ID# 152662
• Poland
  • Dolnoslaskie
    • Wrocław, Dolnoslaskie, Poland, 52-016
      • Prywatny Osrodek Chirurgii Plastycznej Andrzej Bieniek /ID# 169413
• Portugal
  • Porto, Portugal, 4200-319
    • Centro Hospitalar de Sao Joao, EPE /ID# 150885
• Romania
  • Bucuresti
    • Bucharest, Bucuresti, Romania, 011461
      • Spitalul Universitar de Urgenta Elias /ID# 151072
  • Timis
    • Timişoara, Timis, Romania, 300558
      • Spitalul Municipal de Urgenta Timisoara /ID# 151073
• Russian Federation
  • Moscow, Russian Federation, 111539
    • City Clinical Hospital 15 /ID# 151281
  • St. Petersburg, Russian Federation, 193015
    • NW State Med Univ NA Mechnikov /ID# 151197
• Saudi Arabia
  • Najran
    • Riyadh, Najran, Saudi Arabia, 11211
      • King Faisal Specialist Hospital and Research Centre /ID# 153769
• Spain
  • Badalona, Spain, 08916
    • Hospital Univ Germans Trias I Pujol /ID# 150787
  • Barcelona, Spain, 08026
    • Hospital Santa Creu i Sant Pau /ID# 152742
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Maranon /ID# 150788
  • Manises, Spain, 46940
    • Hospital de Manises /ID# 150790
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporac Sanitaria Parc Tauli /ID# 150789
• Sweden
  • Solna, Sweden, 17176
    • Karolinska Univ Sjukhuset /ID# 150817
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Medical Faculty /ID# 150829
  • Bursa, Turkey, 16059
    • Uludag University Medical Faculty /ID# 150831
• United Kingdom
  • London, City Of
    • London, London, City Of, United Kingdom, E11 1NR
      • Whipps Cross Univ Hospital /ID# 151699
• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Wallace Medical Group, Inc. /ID# 171289
    • Encino, California, United States, 91436
      • Encino Research Center / T. Jo /ID# 171347
    • Irvine, California, United States, 92697-1385
      • University of California Irvine /ID# 170054
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane Univ /ID# 168441
  • Massachusetts
    • Boston, Massachusetts, United States, 02215-5400
      • Beth Israel Deaconess Medical Center /ID# 168438
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Hospitals /ID# 200667
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514-4220
      • Univ NC Chapel Hill /ID# 168446
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Ctr /ID# 168447
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital /ID# 168439

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 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	Drug: Placebo; Subcutaneous injections administered as described in arm description
Active Comparator: 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	Drug: Adalimumab; Subcutaneous injections administered as described in arm description; Other Names: Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	At Week12
Percentage of Participants Achieving HiSCR-es 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.	At Week 24
Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site 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.	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.	At Week 12

Collaborators and Investigators

• Sponsor: AbbVie

Publications and helpful links

General Publications

• Bechara FG, Podda M, Prens EP, Horvath B, Giamarellos-Bourboulis EJ, Alavi A, Szepietowski JC, Kirby J, Geng Z, Jean C, Jemec GBE, Zouboulis CC. Efficacy and Safety of Adalimumab in Conjunction With Surgery in Moderate to Severe Hidradenitis Suppurativa: The SHARPS Randomized Clinical Trial. JAMA Surg. 2021 Nov 1;156(11):1001-1009. doi: 10.1001/jamasurg.2021.3655.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2016
• Primary Completion (Actual): May 16, 2019
• Study Completion (Actual): October 16, 2019

Study Registration Dates

• First Submitted: June 20, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimate): June 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 14, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Adalimumab; Hidradenitis Suppurativa; Axilla; Inguinal region; Hurley Stage I, II, or III; Secondary intention; Abcess and inflammatory nodule (AN) count
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; Hidradenitis Suppurativa; Hidradenitis; Anti-Inflammatory Agents; Antirheumatic Agents; Adalimumab
• Other Study ID Numbers: M15-574; 2015-005161-23 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No