A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis

Sponsor
AbbVie
Study ID
NCT02016482
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study is being conducted to assess the safety and efficacy of adalimumab in participants with nail psoriasis.

Key Dates

Start date
Jan 31, 2014
Status verified
Apr 2017
Primary completion
Oct 31, 2015
Completion
Apr 30, 2016

Study Design

Enrollment
217 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Adalimumab (ADA)
    Period A: ADA 40 mg subcutaneous every other week (sc eow) for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
  • Placebo Comparator: Placebo
    Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Primary Outcome Measure

Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26 [ Time Frame: Week 26 ]

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