Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)

Conditions

• Spondylitis, Ankylosing

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 AS.

Key Dates

Start date

Jul 31, 2014

Status verified

Sep 2014

Primary completion

Apr 30, 2016

Completion

Apr 30, 2018

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Ixekizumab Dosing Regimen 1
  Administered by 80 milligram (mg) subcutaneous (SC) injection
• Experimental: Ixekizumab Dosing Regimen 2
  Administered by 80 mg SC Injection
• Placebo Comparator: Placebo
  Placebo for ixekizumab and placebo for adalimumab administered by SC injection
• Active Comparator: Adalimumab
  Administered by 40 mg SC injection

Primary Outcome Measure

Efficacy of Ixekizumab in Participants with Ankylosing Spondylitis (AS). Measure: Assessment of SpondyloArthritis International Society Criteria (ASAS20) [ Time Frame: 16 Weeks ]

Locations (34)

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