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

Hidradenitis Suppurativa (HS) Clinical Trial

— SHARPS  

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

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
• 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
• 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

Related Conditions & MeSH terms

• Hidradenitis
• Hidradenitis Suppurativa
• Hidradenitis Suppurativa (HS)

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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