A Study of Ixekizumab (LY2439821) in bDMARD-Naive Patients with Radiographic Axial Spondyloarthritis
- Conditions
- Radiographic Axial SpondyloarthritisTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]MedDRA version: 19.0 Level: LLT Classification code 10041672 Term: Spondylitis ankylosing System Organ Class: 100000004859
- Registration Number
- EUCTR2015-003932-11-PL
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 340
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 <45 years.
In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (for duration 4 weeks) or cannot tolerate NSAIDS
If taking NSAIDS be on a stable dose for at least 2 weeks prior to randomization
Have given written informed consent
Have a history of prior therapy for axSpa for at least 12 weeks prior to screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 304
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.;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
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): Proportion of patients achieving an ASAS20 response <br> Change from baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) <br> Proportion of patients achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) response<br> Change from baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)<br> Proportion of patients achieving ASDAS inactive disease<br> Change from baseline in magnetic resonance imaging (MRI) of the spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] –Berlin score) <br> Change from baseline in Short Form 36 (SF-36) physical component score (PCS)<br> Change from baseline in ASAS Health Index (ASAS-HI)<br> ;Timepoint(s) of evaluation of this end point: Week 16