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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003932-11-DE

Enrollment

320

Registered

2016-01-14

Start date

2016-04-19

Completion date

Unknown

Last updated

2019-11-25

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

Product Name: Ixekizumab Product Code: LY2439821 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: Ixekizumab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Are ambulatory and at least 18 years of age Diagnosis of radiographic axial spondyloarthritis (raxSpA) 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 16

Exclusion criteria

Exclusion criteria: Have total ankylosis of the spine Have received any prior, or are currently receiving, treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents 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
Secondary Objective: Compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks) to placebo at Week 16;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;Main Objective: Compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks vs placebo in patients with active radiographic axial spondyloarthritis at week 16.	—

Measure

Time frame

Secondary Objective: Compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks) to placebo at Week 16;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;Main Objective: Compare both ixekizumab regimens (80 mg every 2 weeks or 80 mg every 4 weeks vs placebo in patients with active radiographic axial spondyloarthritis at 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 magnetic resonance imaging (MRI) of the spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] –Berlin score) Change from baseline in Short Form 36 (SF-36) physical component score (PCS) Change from baseline in ASAS Health Index (ASAS-HI) ;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 magnetic resonance imaging (MRI) of the spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] –Berlin score) Change from baseline in Short Form 36 (SF-36) physical component score (PCS) Change from baseline in ASAS Health Index (ASAS-HI) ;Timepoint(s) of evaluation of this end point: Week 16

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Countries

Canada, Czech Republic, Germany, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Russian Federation, Taiwan, 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