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

NCT02808975 | Completed Phase 4 Results FDA Drug

• 2 other identifiers: M15-5742015-005161-23
• Study Type: interventional
• Target: 206
• Locations: 23 countries
• Sites: 55

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Percentage of Participants Achieving HiSCR-es at Week 12

  At Week12

• Percentage of Participants Achieving HiSCR-es at Week 24

  At Week 24

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

  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

  At Week 12

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Adalimumab

ACTIVE COMPARATOR

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

Interventions

Placebo DRUG

Subcutaneous injections administered as described in arm description

Placebo

Adalimumab DRUG

Subcutaneous injections administered as described in arm description

Also known as: Humira

Adalimumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie: lead

Study Sites (55)

Wallace Medical Group, Inc. /ID# 171289

Beverly Hills, California, 90211, United States

Location

Encino Research Center / T. Jo /ID# 171347

Encino, California, 91436, United States

Location

University of California Irvine /ID# 170054

Irvine, California, 92697-1385, United States

Location

Tulane Univ /ID# 168441

New Orleans, Louisiana, 70112, United States

Location

Beth Israel Deaconess Medical Center /ID# 168438

Boston, Massachusetts, 02215-5400, United States

Location

University of Michigan Hospitals /ID# 200667

Ann Arbor, Michigan, 48109, United States

Location

Univ NC Chapel Hill /ID# 168446

Chapel Hill, North Carolina, 27514-4220, United States

Location

Penn State Hershey Medical Ctr /ID# 168447

Hershey, Pennsylvania, 17033, United States

Location

Rhode Island Hospital /ID# 168439

Providence, Rhode Island, 02903, United States

Location

CUB Hospital Erasme /ID# 150907

Brussels, Brussels Capital, 1070, Belgium

Location

UZ Gent /ID# 150906

Ghent, Oost-Vlaanderen, 9000, Belgium

Location

NewLab Clinical Research Inc. /ID# 151315

St. John's, Newfoundland and Labrador, A1C 2H5, Canada

Location

York Dermatology Clinic and Research Centre /ID# 151314

Richmond Hill, Ontario, L4C 9M7, Canada

Location

Fundacion Valle Del Lili /ID# 151565

Cali, 760032, Colombia

Location

Hospital Pablo Tobon Uribe /ID# 152693

Medellín, Colombia

Location

Fakultni nemocnice Ostrava /ID# 169174

Ostrava, Praha 5, 708 52, Czechia

Location

Fakult Nem Kralovske Vinohrady /ID# 169173

Prague, 100 34, Czechia

Location

Bispebjerg Hospital /ID# 150796

Copenhagen NV, Capital Region, 2400, Denmark

Location

Sjaellands Universitets Hospit /ID# 150795

Roskilde, Region Sjælland, 4000, Denmark

Location

Polyclinique Courlancy /ID# 157761

Reims, 51100, France

Location

Hopital Prive d'Antony /ID# 157347

Antony, Île-de-France Region, 92160, France

Location

Universitaetsklinikum Erlangen /ID# 167251

Erlangen, Bavaria, 91054, Germany

Location

Charité Universitätsmedizin Campus Mitte /ID# 150875

Berlin, 10117, Germany

Location

Klinikum Ruhr Univ Bochum /ID# 150873

Bochum, 44791, Germany

Location

Klinikum Darmstadt GmbH /ID# 150874

Darmstadt, 64297, Germany

Location

Staedtisches Klinikum Dessau /ID# 150876

Dessau, 06847, Germany

Location

University General Hospital Attikon /ID# 150841

Athens, Attica, 12462, Greece

Location

Genl Hospital Andreas Syggros /ID# 150840

Athens, 16121, Greece

Location

Genl Hospital Andreas Syggros /ID# 150842

Athens, 16121, Greece

Location

St Vincent's University Hosp /ID# 150043

Dublin, D04 T6F4, Ireland

Location

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

Milan, Lombardy, 20122, Italy

Location

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

Ferrara, 44124, Italy

Location

Universita degli Studi di /ID# 150068

Modena, 41124, Italy

Location

Policlinico Univ Tor Vergata /ID# 150142

Rome, 00133, Italy

Location

Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 151027

Monterrey, Nuevo León, 64460, Mexico

Location

Radboud Universitair Medisch Centrum /ID# 152157

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Universitair Medisch Centrum Groningen /ID# 150662

Groningen, 9713 GZ, Netherlands

Location

Erasmus Medisch Centrum /ID# 150672

Rotterdam, 3015 CE, Netherlands

Location

Haukeland University Hospital /ID# 152662

Bergen, Hordaland, 5021, Norway

Location

Prywatny Osrodek Chirurgii Plastycznej Andrzej Bieniek /ID# 169413

Wroclaw, Lower Silesian Voivodeship, 52-016, Poland

Location

Centro Hospitalar de Sao Joao, EPE /ID# 150885

Porto, 4200-319, Portugal

Location

Spitalul Universitar de Urgenta Elias /ID# 151072

Bucharest, București, 011461, Romania

Location

Spitalul Municipal de Urgenta Timisoara /ID# 151073

Timișoara, Timiș County, 300558, Romania

Location

City Clinical Hospital 15 /ID# 151281

Moscow, 111539, Russia

Location

NW State Med Univ NA Mechnikov /ID# 151197

Saint Petersburg, 193015, Russia

Location

King Faisal Specialist Hospital and Research Centre /ID# 153769

Riyadh, Najran Region, 11211, Saudi Arabia

Location

Corporac Sanitaria Parc Tauli /ID# 150789

Sabadell, Barcelona, 08208, Spain

Location

Hospital Univ Germans Trias I Pujol /ID# 150787

Badalona, 08916, Spain

Location

Hospital Santa Creu i Sant Pau /ID# 152742

Barcelona, 08026, Spain

Location

Hospital General Universitario Gregorio Maranon /ID# 150788

Madrid, 28007, Spain

Location

Hospital de Manises /ID# 150790

Manises, 46940, Spain

Location

Karolinska Univ Sjukhuset /ID# 150817

Solna, 17176, Sweden

Location

Hacettepe University Medical Faculty /ID# 150829

Ankara, 06100, Turkey (Türkiye)

Location

Uludag University Medical Faculty /ID# 150831

Bursa, 16059, Turkey (Türkiye)

Location

Whipps Cross Univ Hospital /ID# 151699

London, London, City of, E11 1NR, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 34406349 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Hidradenitis Suppurativa

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin Diseases; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

abbvieclinicaltrials@abbvie.com

800-633-9110

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2016
• First Posted: June 22, 2016
• Study Start: July 18, 2016
• Primary Completion: May 16, 2019
• Study Completion: October 16, 2019
• Last Updated: May 14, 2020
• Results First Posted: May 14, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
• 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.

Locations

BE (2); TU (2); FR (2); CZ (2); IE (1); CO (2); NL (3); CA (2); PT (1); GB (1); ES (5); ME (1); RO (2); DK (2); US (9); IT (4); NO (1); DE (5); PL (1); RU (2); GR (3); SA (1); SE (1)