A Study in Participants With Moderate to Severe Psoriasis (UNCOVER-3)

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Placebo — DRUG
  Administered SC
• 50 mg etanercept — DRUG
  Administered SC
• 80 mg ixekizumab — DRUG
  Administered SC

Study Details

This study will assess the safety and efficacy of ixekizumab (LY2439821), compared to etanercept and placebo in participants with moderate to severe chronic plaque psoriasis.

Key Dates

Start date

Jul 28, 2012

Status verified

Nov 2019

Primary completion

May 22, 2014

Completion

Jul 22, 2019

Study Design

Enrollment

1,346 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, participants are assigned to Dosing Regimen 2.
• Active Comparator: 50 mg etanercept
  Administered by SC injections twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2
• Experimental: 80 mg ixekizumab Dosing Regimen 2
  Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection per Dosing Regimen 2 until Week 264.
• Experimental: 80 mg ixekizumab Dosing Regimen 1
  Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12. At Week 12, arm is assigned to Dosing Regimen 2.

Primary Outcome Measure

Number of Participants Achieving a Static Physician Global Assessment (sPGA) of (0, 1) (Efficacy of Ixekizumab in Participants With Moderate to Severe Chronic Plaque Psoriasis. Measure: sPGA) [ Time Frame: Week 12 ]

Locations (41)

Find similar trials in Anaheim, CA

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