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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02808975
Other study ID # M15-574
Secondary ID 2015-005161-23
Status Completed
Phase Phase 4
First received
Last updated
Start date July 18, 2016
Est. completion date October 16, 2019

Study information

Verified date May 2020
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 206
Est. completion date October 16, 2019
Est. primary completion date May 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Drug:
Placebo
Subcutaneous injections administered as described in arm description
Adalimumab
Subcutaneous injections administered as described in arm description

Locations

Country Name City State
Belgium CUB Hospital Erasme /ID# 150907 Brussels Bruxelles-Capitale
Belgium UZ Gent /ID# 150906 Gent Oost-Vlaanderen
Canada York Dermatology Clinic and Research Centre /ID# 151314 Richmond Hill Ontario
Canada NewLab Clinical Research Inc. /ID# 151315 St. John's Newfoundland and Labrador
Colombia Fundacion Valle Del Lili /ID# 151565 Cali
Colombia Hospital Pablo Tobon Uribe /ID# 152693 Medellín
Czechia Fakultni nemocnice Ostrava /ID# 169174 Ostrava Praha 5
Czechia Fakult Nem Kralovske Vinohrady /ID# 169173 Prague
Denmark Bispebjerg Hospital /ID# 150796 Copenhagen NV Hovedstaden
Denmark Sjaellands Universitets Hospit /ID# 150795 Roskilde Sjælland
France Hopital Prive d'Antony /ID# 157347 Antony Ile-de-France
France Polyclinique Courlancy /ID# 157761 Reims
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 Universitaetsklinikum Erlangen /ID# 167251 Erlangen Bayern
Greece Genl Hospital Andreas Syggros /ID# 150840 Athens
Greece Genl Hospital Andreas Syggros /ID# 150842 Athens
Greece University General Hospital Attikon /ID# 150841 Athens Attiki
Ireland St Vincent's University Hosp /ID# 150043 Dublin
Italy A.O.U Sant'Anna di Ferrara /ID# 150066 Ferrara
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico /ID# 150069 Milan Lombardia
Italy Universita degli Studi di /ID# 150068 Modena
Italy Policlinico Univ Tor Vergata /ID# 150142 Rome
Mexico Hospital Universitario Dr. Jose Eleuterio Gonzalez /ID# 151027 Monterrey Nuevo Leon
Netherlands Universitair Medisch Centrum Groningen /ID# 150662 Groningen
Netherlands Radboud Universitair Medisch Centrum /ID# 152157 Nijmegen Gelderland
Netherlands Erasmus Medisch Centrum /ID# 150672 Rotterdam
Norway Haukeland University Hospital /ID# 152662 Bergen Hordaland
Poland Prywatny Osrodek Chirurgii Plastycznej Andrzej Bieniek /ID# 169413 Wroclaw Dolnoslaskie
Portugal Centro Hospitalar de Sao Joao, EPE /ID# 150885 Porto
Romania Spitalul Universitar de Urgenta Elias /ID# 151072 Bucharest Bucuresti
Romania Spitalul Municipal de Urgenta Timisoara /ID# 151073 Timisoara Timis
Russian Federation City Clinical Hospital 15 /ID# 151281 Moscow
Russian Federation NW State Med Univ NA Mechnikov /ID# 151197 St. Petersburg
Saudi Arabia King Faisal Specialist Hospital and Research Centre /ID# 153769 Riyadh Najran
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 Corporac Sanitaria Parc Tauli /ID# 150789 Sabadell Barcelona
Sweden Karolinska Univ Sjukhuset /ID# 150817 Solna
Turkey Hacettepe University Medical Faculty /ID# 150829 Ankara
Turkey Uludag University Medical Faculty /ID# 150831 Bursa
United Kingdom Whipps Cross Univ Hospital /ID# 151699 London London, City Of
United States University of Michigan Hospitals /ID# 200667 Ann Arbor Michigan
United States Wallace Medical Group, Inc. /ID# 171289 Beverly Hills California
United States Beth Israel Deaconess Medical Center /ID# 168438 Boston Massachusetts
United States Univ NC Chapel Hill /ID# 168446 Chapel Hill North Carolina
United States Encino Research Center / T. Jo /ID# 171347 Encino California
United States Penn State Hershey Medical Ctr /ID# 168447 Hershey Pennsylvania
United States University of California Irvine /ID# 170054 Irvine California
United States Tulane Univ /ID# 168441 New Orleans Louisiana
United States Rhode Island Hospital /ID# 168439 Providence Rhode Island

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Colombia,  Czechia,  Denmark,  France,  Germany,  Greece,  Ireland,  Italy,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Saudi Arabia,  Spain,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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. At Week12
Secondary 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. At Week 24
Secondary 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. From Baseline to Week 12
Secondary 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. At Week 12
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Recruiting NCT06241573 - A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab Phase 2/Phase 3
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