Open-label Study of the Safety and Efficacy of Adalimumab in the Treatment of Hidradenitis Suppurativa (PIONEER (OLE))

AbbVie

Status and phase

Completed

Phase 3

Conditions

Hidradenitis Suppurativa

Treatments

Biological: adalimumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01635764

M12-555

2011-003478-98 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study to evaluate the long term safety, tolerability and efficacy of adalimumab in subjects with moderate to severe hidradenitis suppurativa (HS).

Full description

HS is a painful, chronic skin disease characterized by recurrent inflamed nodules and abscesses, which may rupture to form fistulas and subsequent scarring. This study is an open-label extension study available to subjects who participated in a prior adalimumab study who meet all the inclusion and none of the exclusion criteria.

Enrollment

508 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Subjects who previously participated in a prior Phase 3 AbbVie hidradenitis suppurativa (HS) study (M11-313 or M11-810) and:
1. Completed the study; or
2. Experienced a loss of response (LOR); or
3. Experienced worsening or absence of improvement
  
  Exclusion Criteria:
Prior treatment with any other anti-tumour necrosis factor (anti-TNF) therapy (e.g., infliximab, etanercept), or participation in an adalimumab trial other than a prior Phase 3 AbbVie HS study.
Subject received any oral antibiotic treatment for HS within 28 days prior to the Baseline visit, except for antibiotics permitted in a prior Phase 3 AbbVie HS study.
Subject received prescription topical therapies for the treatment of HS within 14 days prior to the Baseline visit of Study M12-555.