Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) (SPIRIT A1)

Lilly

Status and phase: Withdrawn; Phase 3

Conditions: Spondylitis, Ankylosing

Treatments: Drug: Adalimumab; Drug: Placebo; Drug: Ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT01870284

13650

I1F-MC-RHAO (Other Identifier)

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
• Have active AS defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and the spinal pain (back pain) score ≥4 on a numeric rating scale (NRS)
• Participants should have been on nonsteroidal anti-inflammatory drugs (NSAIDs) with an inadequate response
• Participants who are regularly taking NSAIDs or cyclooxygenase-2 (COX-2) inhibitors as part of their AS therapy are required to be on a stable dose
• Participants who have been on a tumor necrosis factor alpha (TNF) inhibitor (not more than one) must have experienced an inadequate response
• Total duration of prior therapy (NSAIDs and/or adequate physical therapy) should be at least 12 weeks
• Men must agree to use a reliable method of birth control or remain abstinent during the study
• Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Exclusion criteria

• Participants with a total ankylosis of the spine
• Prior or current treatment with adalimumab
• Participants previously treated with any biological or other immunomodulating agents except for those targeting TNF
• Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than ankylosing spondylitis
• Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
• Serious disorder or illness other than ankylosing spondylitis
• Serious infection within the last 3 months
• Breastfeeding or nursing (lactating) women

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 4 patient groups, including a placebo group

Ixekizumab Dosing Regimen 1

Experimental group

Description:

Administered by 80 milligram (mg) subcutaneous (SC) injection

Treatment:

Drug: Ixekizumab

Ixekizumab Dosing Regimen 2

Experimental group

Description:

Administered by 80 mg SC Injection

Treatment:

Drug: Ixekizumab

Placebo

Placebo Comparator group

Description:

Placebo for ixekizumab and placebo for adalimumab administered by SC injection

Treatment:

Drug: Placebo

Adalimumab

Active Comparator group

Description:

Administered by 40 mg SC injection

Treatment:

Drug: Adalimumab