Hidradenitis Suppurativa (HS)Phase 4SHARPSNCT02808975
Safety and Efficacy of Adalimumab (Humira) for Hidradenitis Suppurativa (HS) Peri-Surgically
A Phase 4 study testing Adalimumab in people with Hidradenitis Suppurativa (HS), run by AbbVie at 55 sites in 23 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hidradenitis Suppurativa (HS)
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 206 participants
- Where
- 55 sitesin 23 countries
- Study dates
- 18 Jul 2016to 16 Oct 2019
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
55 sites in 23 countries.
55 sites in 23 countries
United States9 sites
University of Michigan Hospitals /ID# 200667
Ann Arbor, Michigan, 48109
Wallace Medical Group, Inc. /ID# 171289
Beverly Hills, California, 90211
Beth Israel Deaconess Medical Center /ID# 168438
Boston, Massachusetts, 02215-5400
Univ NC Chapel Hill /ID# 168446
Chapel Hill, North Carolina, 27514-4220
Encino Research Center / T. Jo /ID# 171347
Encino, California, 91436
Penn State Hershey Medical Ctr /ID# 168447
Hershey, Pennsylvania, 17033
University of California Irvine /ID# 170054
Irvine, California, 92697-1385
Tulane Univ /ID# 168441
New Orleans, Louisiana, 70112
Rhode Island Hospital /ID# 168439
Providence, Rhode Island, 02903
Germany5 sites
Charité Universitätsmedizin Campus Mitte /ID# 150875
Berlin, 10117
Klinikum Ruhr Univ Bochum /ID# 150873
Bochum, 44791
Klinikum Darmstadt GmbH /ID# 150874
Darmstadt, 64297
Staedtisches Klinikum Dessau /ID# 150876
Dessau, 06847
Universitaetsklinikum Erlangen /ID# 167251
Erlangen, Bavaria, 91054
Spain5 sites
Hospital Univ Germans Trias I Pujol /ID# 150787
Badalona, 08916
Hospital Santa Creu i Sant Pau /ID# 152742
Barcelona, 08026
Hospital General Universitario Gregorio Maranon /ID# 150788
Madrid, 28007
Hospital de Manises /ID# 150790
Manises, 46940
Corporac Sanitaria Parc Tauli /ID# 150789
Sabadell, Barcelona, 08208
Italy4 sites
A.O.U Sant'Anna di Ferrara /ID# 150066
Ferrara, 44124
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150069
Milan, Lombardy, 20122
Universita degli Studi di /ID# 150068
Modena, 41124
Policlinico Univ Tor Vergata /ID# 150142
Rome, 00133
Greece3 sites
University General Hospital Attikon /ID# 150841
Athens, Attica, 12462
Genl Hospital Andreas Syggros /ID# 150840
Athens, 16121
Genl Hospital Andreas Syggros /ID# 150842
Athens, 16121
Netherlands3 sites
Universitair Medisch Centrum Groningen /ID# 150662
Groningen, 9713 GZ
Radboud Universitair Medisch Centrum /ID# 152157
Nijmegen, Gelderland, 6525 GA
Erasmus Medisch Centrum /ID# 150672
Rotterdam, 3015 CE
Belgium2 sites
CUB Hospital Erasme /ID# 150907
Brussels, Brussels Capital, 1070
UZ Gent /ID# 150906
Ghent, Oost-Vlaanderen, 9000
Canada2 sites
York Dermatology Clinic and Research Centre /ID# 151314
Richmond Hill, Ontario, L4C 9M7
NewLab Clinical Research Inc. /ID# 151315
St. John's, Newfoundland and Labrador, A1C 2H5
Colombia2 sites
Fundacion Valle Del Lili /ID# 151565
Cali, 760032
Hospital Pablo Tobon Uribe /ID# 152693
Medellín
Czechia2 sites
Fakultni nemocnice Ostrava /ID# 169174
Ostrava, Praha 5, 708 52
Fakult Nem Kralovske Vinohrady /ID# 169173
Prague, 100 34
Denmark2 sites
Bispebjerg Hospital /ID# 150796
Copenhagen NV, Capital Region, 2400
Sjaellands Universitets Hospit /ID# 150795
Roskilde, Region Sjælland, 4000
France2 sites
Hopital Prive d'Antony /ID# 157347
Antony, Île-de-France Region, 92160
Polyclinique Courlancy /ID# 157761
Reims, 51100
Romania2 sites
Spitalul Universitar de Urgenta Elias /ID# 151072
Bucharest, Bucharest, 011461
Spitalul Municipal de Urgenta Timisoara /ID# 151073
Timișoara, Timiș County, 300558
Russia2 sites
City Clinical Hospital 15 /ID# 151281
Moscow, 111539
NW State Med Univ NA Mechnikov /ID# 151197
Saint Petersburg, 193015
Turkey (Türkiye)2 sites
Hacettepe University Medical Faculty /ID# 150829
Ankara, 06100
Uludag University Medical Faculty /ID# 150831
Bursa, 16059
Mexico1 site
Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 151027
Monterrey, Nuevo León, 64460
Poland1 site
Prywatny Osrodek Chirurgii Plastycznej Andrzej Bieniek /ID# 169413
Wroclaw, Lower Silesian Voivodeship, 52-016
Portugal1 site
Centro Hospitalar de Sao Joao, EPE /ID# 150885
Porto, 4200-319
Saudi Arabia1 site
King Faisal Specialist Hospital and Research Centre /ID# 153769
Riyadh, Najran Region, 11211
United Kingdom1 site
Whipps Cross Univ Hospital /ID# 151699
London, London, City of, E11 1NR
About this study
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
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.
Read the 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)
- Being tested
- Placebo, Adalimumab
- Keywords
- Hidradenitis Suppurativa, Axilla, Inguinal region, Hurley Stage I, II, or III, Adalimumab, Secondary intention, Abcess and inflammatory nodule (AN) count
- Medical subject headings
- Hidradenitis Suppurativa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Subcutaneous injections administered as described in arm description
AdalimumabDrug
Also called Humira
Subcutaneous injections administered as described in arm description
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Week 12
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start18 Jul 2016
- Primary completion16 May 2019
- Study completion16 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hidradenitis Suppurativa (HS)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AbbVie Inc., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808975
- Sponsor's protocol ID
- M15-574
- Other IDs
- 2015-005161-23, 2015
- Acronym
- SHARPS
- Status last verified
- May 2020
- First submitted
- 20 Jun 2016
- Last updated
- 14 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 34406349