Study to Compare Efficacy and Safety of ABP 501 and Adalimumab (HUMIRA®) in Adults With Moderate to Severe Plaque Psoriasis

Sponsor
Amgen
Study ID
NCT01970488
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Adalimumab — BIOLOGICAL
    Administered by subcutaneous injection
  • ABP 501 — BIOLOGICAL
    Administered by subcutaneous injection

Study Details

The purpose of this research study is to compare the efficacy and safety of ABP 501 and adalimumab (HUMIRA®) in adults with plaque psoriasis.

Key Dates

Start date
Oct 18, 2013
Status verified
Apr 2019
Primary completion
Aug 14, 2014
Completion
Mar 18, 2015

Study Design

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

Arms

  • Experimental: ABP 501
    Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. Participants with a PASI 50 response at week 16 continued to receive 40 mg APB 501 until week 48.
  • Active Comparator: Adalimumab
    Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter until week 16. At week 16 participants with a PASI 50 response were re-randomized to treatment with adalimumab or were transitioned to ABP 501 until week 48.

Primary Outcome Measure

Percent Improvement From Baseline in Psoriasis Area and Severity Index (PASI) at Week 16 [ Time Frame: Baseline and Week 16 ]

Related Studies