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

Completed · Phase 4 · Has a placebo group

Conditions studied: Hidradenitis Suppurativa (HS)

In brief

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.

Key facts

Study ID: NCT02808975
Run by: AbbVie
People needed: 206
Starts: 2016-07-18
Expected to finish: 2019-10-16
Last updated by the study team: 2020-05-14

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

Encino Research Center / T. Jo /ID# 171347 — Encino, California, United States
University of California Irvine /ID# 170054 — Irvine, California, United States
Tulane Univ /ID# 168441 — New Orleans, Louisiana, United States
Beth Israel Deaconess Medical Center /ID# 168438 — Boston, Massachusetts, United States
University of Michigan Hospitals /ID# 200667 — Ann Arbor, Michigan, United States
Univ NC Chapel Hill /ID# 168446 — Chapel Hill, North Carolina, United States
Penn State Hershey Medical Ctr /ID# 168447 — Hershey, Pennsylvania, United States
Rhode Island Hospital /ID# 168439 — Providence, Rhode Island, United States
CUB Hospital Erasme /ID# 150907 — Brussels, Brussels Capital, Belgium
UZ Gent /ID# 150906 — Ghent, Oost-Vlaanderen, Belgium
NewLab Clinical Research Inc. /ID# 151315 — St. John's, Newfoundland and Labrador, Canada
York Dermatology Clinic and Research Centre /ID# 151314 — Richmond Hill, Ontario, Canada
Fundacion Valle Del Lili /ID# 151565 — Cali, Colombia
Hospital Pablo Tobon Uribe /ID# 152693 — Medellín, Colombia
Fakultni nemocnice Ostrava /ID# 169174 — Ostrava, Praha 5, Czechia
Fakult Nem Kralovske Vinohrady /ID# 169173 — Prague, Czechia
Bispebjerg Hospital /ID# 150796 — Copenhagen NV, Capital Region, Denmark
Sjaellands Universitets Hospit /ID# 150795 — Roskilde, Region Sjælland, Denmark
Polyclinique Courlancy /ID# 157761 — Reims, France
Hopital Prive d'Antony /ID# 157347 — Antony, Île-de-France Region, France
Universitaetsklinikum Erlangen /ID# 167251 — Erlangen, Bavaria, Germany
Charité Universitätsmedizin Campus Mitte /ID# 150875 — Berlin, Germany
Klinikum Ruhr Univ Bochum /ID# 150873 — Bochum, Germany
Klinikum Darmstadt GmbH /ID# 150874 — Darmstadt, Germany
Wallace Medical Group, Inc. /ID# 171289 — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.