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

Eli Lilly and Company

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Spondylitis, Ankylosing

Interventions

IxekizumabDRUG

Administered SC

PlaceboDRUG

Administered SC

AdalimumabDRUG

Administered SC

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (125)

Outcomes

Primary Outcomes

Efficacy of Ixekizumab in Participants with Ankylosing Spondylitis (AS). Measure: Assessment of SpondyloArthritis International Society Criteria (ASAS20)

Time frame: 16 Weeks

Secondary Outcomes

Efficacy of Ixekizumab in Participants with AS. Measure: ASAS

Time frame: 16 Weeks

Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)

Time frame: Baseline through 16 Weeks

Efficacy of Ixekizumab in Participants with AS. Measure: Non-Arthritic Disease Assessments

Time frame: Baseline through 16 Weeks

Efficacy of Ixekizumab in Participants with AS. Measure: Peripheral Joint Counts

Time frame: 16 Weeks

Efficacy of Ixekizumab in Participants with AS. Measure: Spinal Mobility

Time frame: Baseline through 16 Weeks

Efficacy of Ixekizumab in Participants with AS. Measure: modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)

Time frame: Baseline through 108 Weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Birmingham, Alabama, United States

Little Rock, Arkansas, United States

Upland, California, United States

Denver, Colorado, United States

Trumbull, Connecticut, United States

Tampa, Florida, United States

Atlanta, Georgia, United States

Decatur, Georgia, United States

Marietta, Georgia, United States

Boise, Idaho, United States

...and 115 more locations