A multicenter study of the safety and efficacy of adalimumab in subjectswith moderate to severe hidradenitis suppurativa

Conditions: Hidradenitis Supperativa
MedDRA version: 14.1Level: LLTClassification code 10020041Term: Hidradenitis suppurativaSystem Organ Class: 100000004858
Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

Registration Number: EUCTR2011-003406-24-SE

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

• Adult subjects must have a diagnosis of HS for at least 1 year (365 days) prior to Baseline;
• HS lesions must be present in at least two distinct anatomic areas, one of which must be at least Hurley Stage II or Hurley Stage III;
• Subject must have stable HS for at least 2 months (60 days) prior to Screening and also at the Baseline visit as determined by the investigator through subject interview and review of medical history;
• Subject must have had an inadequate response to at least a 3-month (90 days) trial of an oral antibiotic for treatment of HS (or demonstrated intolerance to, or have a contraindication to, oral antibiotics for treatment of their HS);
• Subject must have an AN count of greater than or equal to 3 at the Baseline visit;
• Subject has a negative TB screening assessment (including a PPD test or Quantiferon-TB Gold test, or equivalent) and negative chest x-ray (CXR) (posterior-anterior [PA] and lateral view) at Screening;
• Subject must agree to daily use (and throughout the entirety of the study) of one of the following over-the-counter topical antiseptics on their HS lesions: chlorhexidine gluconate, triclosan, benzoyl peroxide, or dilute bleach in bathwater;
• Subject is judged to be in good general health, as determined by the Principal Investigator based upon the results of a medical history, physical examination, laboratory profile, CXR and a 12 lead ECG performed during the Screening period and confirmed at Baseline.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 225
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 75

Exclusion Criteria

• Prior treatment with adalimumab or other anti-TNF therapy (e.g., infliximab or etanercept), or participation in an adalimumab trial;
• Subjects on permitted oral antibiotic treatment (doxcycline or minocycline only) for HS who have not been on a stable dose for at least 28 days prior to the Baseline visit;
• Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to the Baseline visit;
• If entering the study on concomitant oral analgesics for non-HS-related pain:
• Subject on opioid analgesics within 14 days prior to Baseline visit;
• Subject not on a stable dose of non-opioid oral analgesics for at least 14 days prior to the Baseline visit (PRN is not considered a stable dose).
• Subject requires, or is expected to require, opioid analgesics for any reason (excluding tramadol);
• Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline visit;
• Subject received systemic non-biologic therapies for HS with potential therapeutic impact for HS less than 28 days prior to Baseline visit (other than permitted oral antibiotics);
• Subject has a draining fistula count of greater than 20 at the Baseline visit;
• Infection(s) requiring treatment with intravenous (IV) anti-infectives (antibiotics, antivirals, antifungals) within 30 days prior to Baseline or oral anti-infectives (antibiotics, antivirals, antifungals) within 14 days prior to Baseline, except as required as part of an anti-TB regimen;
• Any other active skin disease or condition (e.g., bacterial, fungal or viral infection) that may interfere with assessment of HS;
• History of demyelinating disease (including myeleitis) or neurologic symptoms suggestive of demyelinating disease;
• History of invasive infection (e.g., listeriosis, histoplasmosis), human immunodeficiency virus (HIV);
• Subject has an active systemic viral infection or any active viral infection that based on the investigator's clinical assessment make the subject an unsuitable candidate for the study;
• Hepatitis B: HBsAg positive (+) or detected sensitivity on the HBV-DNA PCR qualitative test for HBc Ab/HBsAb positive subjects;
• Chronic recurring infections or active TB;
• History of moderate to severe congestive heart failure (NYHA class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol;
• Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma or localized carcinoma in situ of the cervix;
• Pregnant or lactating females.