A Study of Ixekizumab (LY2439821) in bDMARD-Naive Patients with Radiographic Axial Spondyloarthritis

Phase 1

• Conditions: Radiographic Axial Spondyloarthritis; MedDRA version: 19.0 Level: LLT Classification code 10041672 Term: Spondylitis ankylosing System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2015-003932-11-NL
• Lead Sponsor: Eli Lilly and Company

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-11
• Study Completion: 2018-10-17
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 340

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 <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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified