A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis

Conditions

• Spondyloarthritis

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

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive participants with radiographic axial spondyloarthritis (rad-axSpA).

Key Dates

Start date

May 2, 2016

Status verified

Nov 2018

Primary completion

Dec 8, 2017

Completion

Oct 17, 2018

Study Design

Enrollment

341 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Q2W Ixekizumab
  Double Blind Period: Starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 14. Extended Treatment Period: 80 mg ixekizumab given SC Q2W from week 16 to week 52.
• Experimental: Q4W Ixekizumab
  Double Blind Period: Starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 14. Extended Treatment Period: 80 mg ixekizumab given SC Q4W from week 16 to week 52.
• Placebo Comparator: Placebo
  Double Blind Period: Placebo given SC Q2W to week 14. Extended Treatment Period: 80 mg ixekizumab given SC Q2W or Q4W from week 16 to week 52.
• Active Comparator: Adalimumab
  Double Blind Period: 40 mg Adalimumab given SC Q2W to week 14. Extended Treatment Period: 80 mg ixekizumab given SC Q2W or Q4W from week 20 to week 52.

Primary Outcome Measure

Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response [ Time Frame: Week 16 ]

Locations (19)

Find similar trials in Phoenix, AZ

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