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

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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

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

Trial documents
2

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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