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

May 4, 2020 updated by: AbbVie

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 12
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving HiSCR-es at Week 12
Time Frame: 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.
At Week12
Percentage of Participants Achieving HiSCR-es at Week 24
Time Frame: 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
Time Frame: 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
Time Frame: 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.
At Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 18, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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