MYL-1401A Efficacy and Safety Comparability Study to Humira®

Sponsor
Mylan Inc.
Study ID
NCT02714322
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • MYL-1401A (Adalimumab) — BIOLOGICAL
    MYL-1401A initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose
  • Humira® (Adalimumab) — BIOLOGICAL
    Humira® initial dose of 80 mg administered sc, followed by 40 mg sc given every other week starting 1 week after the initial dose

Study Details

To assess the equivalence of MYL-1401A to Humira® with regards to efficacy in subjects with moderate-to-severe chronic plaque psoriasis

Key Dates

Start date
Jun 30, 2015
Status verified
Mar 2022
Primary completion
May 31, 2016
Completion
Mar 31, 2017

Study Design

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

Arms

  • Experimental: MYL-1401A (Adalimumab)
    MYL-1401A initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose
  • Active Comparator: Humira® (Adalimumab)
    Humira® initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose

Primary Outcome Measure

Percent improvement in PASI from Baseline [ Time Frame: Baseline and Week 12 ]

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