A Study of Ixekizumab in Patients with Axial Spondyloarthritis who have Previously Taken Tumor Necrosis Factor Inhibitors for Their Condition.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled 16 Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in TNFi-Experienced Patients with Radiographic Axial Spondyloarthritis - CoASt-W

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003937-84-GB

Enrollment

300

Registered

2015-12-22

Start date

2016-03-07

Completion date

Unknown

Last updated

2020-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiographic Axial Spondyloarthritis MedDRA version: 20.0 Level: LLT Classification code 10041672 Term: Spondylitis ankylosing System Organ Class: 100000004859

Interventions

Trade Name: Taltz Product Name: LY2439821 Product Code: Ixekizumab Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ixekizumab Other descriptive name: LY2439821 C

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Are at least 18 years of age -Have an established diagnosis of radiographic axial spondyloarthritis (r-axSpA) with sacroiliitis defined radiographically according to the mNY criteria -Patients have a history of back pain =3 months with age at onset =65 years) yes F.1.3.1 Number of subjects for this age range 30

Exclusion criteria

Exclusion criteria: - Have total ankylosis of the spine -Have taken none or more than two tumor necrosis factor inhibitor medications - Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year. - Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis - Have a compromised immune system. - Have any other serious and/or uncontrolled diseases. - Have either a current diagnosis or a recent history of malignant disease. - Have had Major surgery within 8 weeks of baseline, or will require surgery during the study - Are pregnant or breastfeeding

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks) vs placebo in tumor necrosis factor inhibitor (TNFi) experienced patients with active radiographic axial spondyloarthritis (r-axSpA) at Week 16.;Secondary Objective: To compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks) to placebo at Week 16 on signs and symptoms, function, mobility, and quality of life in TNFi experienced patients with r-axSpA.;Primary end point(s): Proportion of patients achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) response.;Timepoint(s) of evaluation of this end point: Week 16	—

Measure

Time frame

Main Objective: Compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks) vs placebo in tumor necrosis factor inhibitor (TNFi) experienced patients with active radiographic axial spondyloarthritis (r-axSpA) at Week 16.;Secondary Objective: To compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks) to placebo at Week 16 on signs and symptoms, function, mobility, and quality of life in TNFi experienced patients with r-axSpA.;Primary end point(s): Proportion of patients achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) response.;Timepoint(s) of evaluation of this end point: Week 16

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Secondary

Measure	Time frame
Secondary end point(s): -Proportion of patients achieving an ASAS20 response -Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) -Proportion of patients achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) response -Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) -Proportion of patients achieving ASDAS inactive disease -Change from baseline in Short Form 36 (SF-36) physical component score (PCS) -Change from baseline in ASAS Health Index (ASAS HI) -Change from baseline in magnetic resonance imaging (MRI) of the spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] –Berlin score). (This endpoint applies to MRI addendum only).;Timepoint(s) of evaluation of this end point: Week 16	—

Measure

Time frame

Secondary end point(s): -Proportion of patients achieving an ASAS20 response -Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) -Proportion of patients achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) response -Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) -Proportion of patients achieving ASDAS inactive disease -Change from baseline in Short Form 36 (SF-36) physical component score (PCS) -Change from baseline in ASAS Health Index (ASAS HI) -Change from baseline in magnetic resonance imaging (MRI) of the spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] –Berlin score). (This endpoint applies to MRI addendum only).;Timepoint(s) of evaluation of this end point: Week 16

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Countries

Argentina, Brazil, Canada, Finland, France, Germany, Hungary, Israel, Italy, Korea, Republic of, Mexico, Netherlands, Poland, Puerto Rico, Spain, United Kingdom, United States

Contacts

Public ContactClinical Trial Registry Office

Eli Lilly

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026