A Phase 3 Study in Participants With Moderate to Severe Psoriasis (UNCOVER-2)

Conditions

• Psoriasis

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

May 18, 2012

Status verified

Aug 2019

Primary completion

Mar 25, 2014

Completion

Jun 18, 2019

Study Design

Enrollment

1,224 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 80 mg ixekizumab Dosing Regimen 1
  Administered by two 80 mg subcutaneous (SC) injections at Week 0, then one 80 mg SC injection per Dosing Regimen 1 until Week 12. At Week 12, ixekizumab responders are re-randomized to placebo, Dosing Regimen 2 or Dosing Regimen 3. Ixekizumab non-responders are 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 12. At Week 12, ixekizumab responders are re-randomized to placebo, Dosing Regimen 2 or Dosing Regimen 3. Ixekizumab non-responders are assigned to Dosing Regimen 2.
• Experimental: 80 mg ixekizumab Dosing Regimen 3
  Dosing Regimen 3 is not used until Week 12. At Week 12, ixekizumab responders re-randomized to this arm will receive Dosing Regimen 3.
• Active Comparator: 50 mg etanercept
  Administered by one 50 mg SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, etanercept responders are assigned to placebo, and nonresponders to Dosing Regimen 2.
• Placebo Comparator: Placebo for ixekizumab
  Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 until Week 12. At Week 12, placebo responders are assigned to placebo, and nonresponders to Dosing Regimen 2. Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12 was used to blind etanercept injections for Dosing Regimen 1, Dosing Regimen 2, and Placebo Comparator groups.

Primary Outcome Measure

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

Locations (41)

Find similar trials in Phoenix, AZ

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