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

Phase 1

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

Registration Number: EUCTR2011-003478-98-CZ

Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

1. Subjects who previously participated in a prior Phase 3 Abbott HS study and:
• Completed the study; or
• Experienced a loss of response (LOR); or
• Experienced Worsening or Absence of Improvement

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 450
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 150

Exclusion Criteria

1. Prior treatment with any other anti-TNF therapy (e.g., infliximab, etanercept), or participation in an adalimumab trial other than a prior Phase 3 Abbott HS study.
2. 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 Abbott HS study.
3. Subject received oral concomitant analgesics (including opioids) for HS-related pain within 14 days prior to the Baseline visit, except for permitted analgesics taken in the prior Phase 3 Abbott HS study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety, tolerability, and efficacy of adalimumab in subjects with moderate to severe hidradenitis suppurativa (HS) who enter from a prior Phase 3 HS study.;Secondary Objective: N/A;Primary end point(s): Improvement in lesion counts, other lesion assessments, and subject completed questionnaires.;Timepoint(s) of evaluation of this end point: Ongoing throughout study.

Secondary Outcome Measures