A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab inSubjects with Moderate to Severe Hidradenitis Suppurativa

AbbVie Deutschland GmbH & Co. KG0 sites300 target enrollmentFebruary 3, 2012

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

DrugsHumira 40 mg solution for injection in pre-filled syringe

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hidradenitis Supperativa
Sponsor: AbbVie Deutschland GmbH & Co. KG
Enrollment: 300
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 3, 2012

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

AbbVie Deutschland GmbH & Co. KG

Eligibility Criteria

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 and/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:

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;