A Study of Ixekizumab (LY2439821) in Chinese Participants With Radiographic Axial Spondyloarthritis

Lilly

Status and phase: Completed; Phase 3

Conditions: Spondyloarthritis

Treatments: Drug: Ixekizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04285229

16721

I1F-MC-RHCH (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in Chinese participants with radiographic axial spondyloarthritis (r-axSpA).

Enrollment: 147 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have an established diagnosis of radiographic axial spondyloarthritis (r-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
• Participants have a history of back pain ≥3 months with age at onset <45 years.
• Biologic naïve or have had prior treatment with 1 tumor necrosis factor (TNF) inhibitor.
• Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
• Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

Exclusion criteria

• Have total ankylosis of the spine.
• 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.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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147 participants in 2 patient groups, including a placebo group

Ixekizumab

Experimental group

Description:

Participants received Ixekizumab during the double-blind and extended treatment periods (i.e.,) starting dose of 160 milligrams (mg) Ixekizumab in the beginning week followed by 80 mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection. No treatments were administered during the follow-up period.

Treatment:

Drug: Ixekizumab

Placebo

Placebo Comparator group

Description:

Participants received placebo every four weeks (Q4W) by subcutaneous (SC) injection during the double-blind period. During the extension period, they received starting dose of 160 milligrams (mg) Ixekizumab in the beginning week followed by 80 mg Ixekizumab once every four weeks (Q4W) by subcutaneous injection. No treatments were administered during follow-up period.

Treatment:

Drug: Ixekizumab

Drug: Placebo