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

NCT ID: NCT02808975

Last Updated: 2020-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-18
• Study Completion Date: 2019-10-16

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.

Conditions

Hidradenitis Suppurativa (HS)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subcutaneous injections administered as described in arm description

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

Group Type: ACTIVE_COMPARATOR

Adalimumab

Intervention Type: DRUG

Subcutaneous injections administered as described in arm description

Interventions

Placebo

Subcutaneous injections administered as described in arm description

Intervention Type: DRUG

Adalimumab

Subcutaneous injections administered as described in arm description

Intervention Type: DRUG

Other Intervention Names

Humira

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Locations

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

UZ Gent /ID# 150906

Ghent, Oost-Vlaanderen, Belgium

NewLab Clinical Research Inc. /ID# 151315

St. John's, Newfoundland and Labrador, Canada

York Dermatology Clinic and Research Centre /ID# 151314

Richmond Hill, Ontario, Canada

Fundacion Valle Del Lili /ID# 151565

Cali, , Colombia

Hospital Pablo Tobon Uribe /ID# 152693

Medellín, , Colombia

Fakultni nemocnice Ostrava /ID# 169174

Ostrava, Praha 5, Czechia

Fakult Nem Kralovske Vinohrady /ID# 169173

Prague, , Czechia

Bispebjerg Hospital /ID# 150796

Copenhagen NV, Capital Region, Denmark

Sjaellands Universitets Hospit /ID# 150795

Roskilde, Region Sjælland, Denmark

Polyclinique Courlancy /ID# 157761

Reims, , France

Hopital Prive d'Antony /ID# 157347

Antony, Île-de-France Region, France

Universitaetsklinikum Erlangen /ID# 167251

Erlangen, Bavaria, Germany

Charité Universitätsmedizin Campus Mitte /ID# 150875

Berlin, , Germany

Klinikum Ruhr Univ Bochum /ID# 150873

Bochum, , Germany

Klinikum Darmstadt GmbH /ID# 150874

Darmstadt, , Germany

Staedtisches Klinikum Dessau /ID# 150876

Dessau, , Germany

University General Hospital Attikon /ID# 150841

Athens, Attica, Greece

Genl Hospital Andreas Syggros /ID# 150840

Athens, , Greece

Genl Hospital Andreas Syggros /ID# 150842

Athens, , Greece

St Vincent's University Hosp /ID# 150043

Dublin, , Ireland

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150069

Milan, Lombardy, Italy

A.O.U Sant'Anna di Ferrara /ID# 150066

Ferrara, , Italy

Universita degli Studi di /ID# 150068

Modena, , Italy

Policlinico Univ Tor Vergata /ID# 150142

Rome, , Italy

Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 151027

Monterrey, Nuevo León, Mexico

Radboud Universitair Medisch Centrum /ID# 152157

Nijmegen, Gelderland, Netherlands

Universitair Medisch Centrum Groningen /ID# 150662

Groningen, , Netherlands

Erasmus Medisch Centrum /ID# 150672

Rotterdam, , Netherlands

Haukeland University Hospital /ID# 152662

Bergen, Hordaland, Norway

Prywatny Osrodek Chirurgii Plastycznej Andrzej Bieniek /ID# 169413

Wroclaw, Lower Silesian Voivodeship, Poland

Centro Hospitalar de Sao Joao, EPE /ID# 150885

Porto, , Portugal

Spitalul Universitar de Urgenta Elias /ID# 151072

Bucharest, București, Romania

Spitalul Municipal de Urgenta Timisoara /ID# 151073

Timișoara, Timiș County, Romania

City Clinical Hospital 15 /ID# 151281

Moscow, , Russia

NW State Med Univ NA Mechnikov /ID# 151197

Saint Petersburg, , Russia

King Faisal Specialist Hospital and Research Centre /ID# 153769

Riyadh, Najran Region, Saudi Arabia

Corporac Sanitaria Parc Tauli /ID# 150789

Sabadell, Barcelona, Spain

Hospital Univ Germans Trias I Pujol /ID# 150787

Badalona, , Spain

Hospital Santa Creu i Sant Pau /ID# 152742

Barcelona, , Spain

Hospital General Universitario Gregorio Maranon /ID# 150788

Madrid, , Spain

Hospital de Manises /ID# 150790

Manises, , Spain

Karolinska Univ Sjukhuset /ID# 150817

Solna, , Sweden

Hacettepe University Medical Faculty /ID# 150829

Ankara, , Turkey (Türkiye)

Uludag University Medical Faculty /ID# 150831

Bursa, , Turkey (Türkiye)

Whipps Cross Univ Hospital /ID# 151699

London, London, City of, United Kingdom

Countries

United States; Belgium; Canada; Colombia; Czechia; Denmark; France; Germany; Greece; Ireland; Italy; Mexico; Netherlands; Norway; Poland; Portugal; Romania; Russia; Saudi Arabia; Spain; Sweden; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 34406349 (View on PubMed)

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

2015-005161-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M15-574

Identifier Type: -

Identifier Source: org_study_id