Clinical trial NCT02808975: Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hidradenitis Suppurativa (HS)
Keywords: Hidradenitis Suppurativa
Axilla
Inguinal region
Hurley Stage I, II, or III
Adalimumab
Secondary intention
Abcess and inflammatory nodule (AN) count
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-06-22
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
timeFrame: At Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving HiSCR-es at Week 12
timeFrame: At Week12
measure: Percentage of Participants Achieving HiSCR-es at Week 24
timeFrame: At Week 24
measure: Percent Change in the Surface Area of the Hidradenitis Suppurativa (HS) Surgical Site From Baseline to Week 12
timeFrame: From Baseline to Week 12
measure: Percentage of Participants at Week 12 That Require a Less Extensive Surgery Than the Surgical Plan (Determined at Baseline) or No Surgery
timeFrame: At Week 12
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Wallace Medical Group, Inc. /ID# 171289
state: California
city: Encino
country: United States
facility: Encino Research Center / T. Jo /ID# 171347
state: California
city: Irvine
country: United States
facility: University of California Irvine /ID# 170054
state: California
city: New Orleans
country: United States
facility: Tulane Univ /ID# 168441
state: Louisiana
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center /ID# 168438
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Hospitals /ID# 200667
state: Michigan
city: Chapel Hill
country: United States
facility: Univ NC Chapel Hill /ID# 168446
state: North Carolina
city: Hershey
country: United States
facility: Penn State Hershey Medical Ctr /ID# 168447
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital /ID# 168439
state: Rhode Island
city: Brussels
country: Belgium
facility: CUB Hospital Erasme /ID# 150907
state: Bruxelles-Capitale
city: Gent
country: Belgium
facility: UZ Gent /ID# 150906
state: Oost-Vlaanderen
city: St. John's
country: Canada
facility: NewLab Clinical Research Inc. /ID# 151315
state: Newfoundland and Labrador
city: Richmond Hill
country: Canada
facility: York Dermatology Clinic and Research Centre /ID# 151314
state: Ontario
city: Cali
country: Colombia
facility: Fundacion Valle Del Lili /ID# 151565
city: Medellín
country: Colombia
facility: Hospital Pablo Tobon Uribe /ID# 152693
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava /ID# 169174
state: Praha 5
city: Prague
country: Czechia
facility: Fakult Nem Kralovske Vinohrady /ID# 169173
city: Copenhagen NV
country: Denmark
facility: Bispebjerg Hospital /ID# 150796
state: Hovedstaden
city: Roskilde
country: Denmark
facility: Sjaellands Universitets Hospit /ID# 150795
state: Sjælland
city: Antony
country: France
facility: Hopital Prive d'Antony /ID# 157347
state: Ile-de-France
city: Reims
country: France
facility: Polyclinique Courlancy /ID# 157761
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen /ID# 167251
state: Bayern
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Campus Mitte /ID# 150875
city: Bochum
country: Germany
facility: Klinikum Ruhr Univ Bochum /ID# 150873
city: Darmstadt
country: Germany
facility: Klinikum Darmstadt GmbH /ID# 150874
city: Dessau
country: Germany
facility: Staedtisches Klinikum Dessau /ID# 150876
city: Athens
country: Greece
facility: University General Hospital Attikon /ID# 150841
state: Attiki
city: Athens
country: Greece
facility: Genl Hospital Andreas Syggros /ID# 150840
city: Athens
country: Greece
facility: Genl Hospital Andreas Syggros /ID# 150842
city: Dublin
country: Ireland
facility: St Vincent's University Hosp /ID# 150043
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150069
state: Lombardia
city: Ferrara
country: Italy
facility: A.O.U Sant'Anna di Ferrara /ID# 150066
city: Modena
country: Italy
facility: Universita degli Studi di /ID# 150068
city: Rome
country: Italy
facility: Policlinico Univ Tor Vergata /ID# 150142
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 151027
state: Nuevo Leon
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum /ID# 152157
state: Gelderland
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen /ID# 150662
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum /ID# 150672
city: Bergen
country: Norway
facility: Haukeland University Hospital /ID# 152662
state: Hordaland
city: Wrocław
country: Poland
facility: Prywatny Osrodek Chirurgii Plastycznej Andrzej Bieniek /ID# 169413
state: Dolnoslaskie
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao, EPE /ID# 150885
city: Bucharest
country: Romania
facility: Spitalul Universitar de Urgenta Elias /ID# 151072
state: Bucuresti
city: Timişoara
country: Romania
facility: Spitalul Municipal de Urgenta Timisoara /ID# 151073
state: Timis
city: Moscow
country: Russian Federation
facility: City Clinical Hospital 15 /ID# 151281
city: St. Petersburg
country: Russian Federation
facility: NW State Med Univ NA Mechnikov /ID# 151197
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital and Research Centre /ID# 153769
state: Najran
city: Sabadell
country: Spain
facility: Corporac Sanitaria Parc Tauli /ID# 150789
state: Barcelona
city: Badalona
country: Spain
facility: Hospital Univ Germans Trias I Pujol /ID# 150787
city: Barcelona
country: Spain
facility: Hospital Santa Creu i Sant Pau /ID# 152742
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 150788
city: Manises
country: Spain
facility: Hospital de Manises /ID# 150790
city: Solna
country: Sweden
facility: Karolinska Univ Sjukhuset /ID# 150817
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty /ID# 150829
city: Bursa
country: Turkey
facility: Uludag University Medical Faculty /ID# 150831
city: London
country: United Kingdom
facility: Whipps Cross Univ Hospital /ID# 151699
state: London, City Of
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: 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.