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



Status:Active, not recruiting
Conditions:Dermatology, Dermatology
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 65
Updated:3/8/2019
Start Date:July 18, 2016
End Date:September 18, 2019

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A Phase 4, Double-blind, Randomised, 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 is to assess the safety and efficacy of adalimumab prior to
surgery in subjects with moderate to severe Hidradenitis Suppurativa (HS) who are surgical
candidates.


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:

- Has a draining fistula count of greater than 20 at the Baseline visit

- Requires surgery at any anatomical site other than an unilateral axilla or inguinal
region site

- Requires surgical management prior to Week 13

- Requires, based on the designated surgeon's assessment, excisional surgery with
primary closure as the method of closure being most beneficial for the participant
We found this trial at
10
sites
Boston, Massachusetts 02215
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Boston, MA
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Ann Arbor, MI
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Beverly Hills, California 90211
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Beverly Hills, CA
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Brussels, Bruxelles-Capitale
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Brussels,
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Chapel Hill, North Carolina 27514
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Chapel Hill, NC
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Encino, CA
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Hershey, Pennsylvania 17033
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Hershey, PA
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Irvine, CA
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New Orleans, Louisiana 70112
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from
New Orleans, LA
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Providence, Rhode Island 02903
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from
Providence, RI
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