Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2013
• Main ID: NCT01468207
• Date of registration: 07/11/2011
• Primary sponsor: AbbVie (prior sponsor, Abbott)
• Public title: Efficacy and Safety Study of Adalimumab in Treatment of Hidradenitis Suppurativa PIONEER I
• Scientific title: Clinical Study Protocol M11-313 - PIONEER I A Phase 3 Multicenter Study of the Safety and Efficacy of Adalimumab in Subjects With Moderate to Severe Hidradenitis Suppurativa
• Date of first enrolment: September 2010
• Target sample size: 300
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01468207
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Australia, Canada, Czech Republic, Germany, Hungary, United States

Contacts

• Name: Andrea Byars, BS

• Name: David Williams, MD
• Affiliation: AbbVie

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adults must have a diagnosis of hidradenitis suppurativa (HS) for at least 1 year
prior to Baseline.

- HS lesions must be present in at least two distinct anatomical areas, one of which
must be at least Hurley Stage II or Hurley Stage III.

- Subject must have stable HS for at least 60 days prior to Screening visit and at
Baseline visit.

- Subject must have experienced an inadequate response to at least a 90 day treatment
of oral antibiotics for treatment of HS.

- Subject must have a count of greater than or equal to 3 at baseline.

Exclusion Criteria:

- Subject was previously treated with adalimumab or another anti-TNF therapy (e.g.,
infliximab or etanercept).

- Subject received any oral antibiotic treatment for HS within 28 days prior to
Baseline.

- Subject received oral concomitant analgesics (including opioids) for HS-related pain
within 14 days prior to 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 ("as needed" is not considered a stable dose).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Hidradenitis Suppurativa (HS)

Intervention(s)

Biological: adalimumab

Biological: placebo

Primary Outcome(s)

Proportion of subjects achieving clinical response at Week 12 [Time Frame: Baseline (Week 0) up to Week 12]

Secondary Outcome(s)

Change in Sartorius scale [Time Frame: Baseline (Week 0) and Week 12]

Proportion of subjects achieving counts of 0, 1, or 2 at Week 12 [Time Frame: Baseline (Week 0) up to Week 12]

Reduction in patient skin pain assessment at Week 12 [Time Frame: Baseline (Week 0) up to Week 12]

Secondary ID(s)

2011-003400-20

M11-313

Source(s) of Monetary Support

Please refer to primary and secondary sponsors