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

Sponsor
Eli Lilly and Company
Study ID
NCT04285229
Phase
PHASE3
Status
Completed

Conditions

  • Spondyloarthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ixekizumab — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

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

Key Dates

Start date
Apr 10, 2020
Status verified
Apr 2023
Primary completion
Mar 31, 2021
Completion
Mar 17, 2022

Study Design

Enrollment
147 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ixekizumab
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response in Biological Disease-modifying Antirheumatic Drug (bDMARD)-naïve Participants [ Time Frame: Week 16 ]

Related Studies