A Study of Ixekizumab in Participants With Active Psoriatic Arthritis

Conditions

• Psoriasis, Arthritic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ixekizumab — DRUG
  Administered SC
• Placebo — DRUG
  Administered SC
• Adalimumab — DRUG
  Administered SC

Study Details

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active psoriatic arthritis.

Key Dates

Start date

Dec 31, 2012

Status verified

Dec 2018

Primary completion

Dec 31, 2014

Completion

Sep 30, 2017

Study Design

Enrollment

417 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ixekizumab Q2W
  Administered by 80 milligram (mg) subcutaneous (SC) injection every 2 weeks (Q2W).
• Experimental: Ixekizumab Q4W
  Administered by 80 mg SC injection every 4 weeks (Q4W).
• Placebo Comparator: Placebo
  Placebo for ixekizumab and placebo for adalimumab administered by SC injection.
• Active Comparator: Adalimumab Q2W
  Administered by 40 mg SC injection Q2W.

Primary Outcome Measure

Percentage of Participants Achieving American College of Rheumatology 20 (ACR20) Response at Week 24 (Efficacy of Ixekizumab in Participants With Active Psoriatic Arthritis. Measure: American College of Rheumatology 20 Index [ACR20]) [ Time Frame: Week 24 ]

Locations (37)

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