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Clinical Trials List

Protocol NumberI1F-MC-RHBV
NCT Number(ClinicalTrials.gov Identfier)NCT02696785
Completed

2016-02-29 - 2019-02-28

Phase III

Terminated5

ICD-10M48.8X9

Other specified spondylopathies, site unspecified

ICD-9720.0

Ankylosing spondylitis

A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD-Naive Patients with Radiographic Axial Spondyloarthritis

  • Trial Applicant

    ELI LILLY AND COMPANY(TAIWAN), INC.

  • Sponsor

    Eli Lilly and Company

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Joung-Liang Lan 風濕免疫科
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 陳英州 風濕免疫科
Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 陳宏安 風濕免疫科
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator 魏正宗 風濕免疫科
Chung Shan Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator SONG-CHOU HSIEH Division of Rheumatology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Condition/Disease

Radiographic Axial Spondyloarthritis

Objectives

Primary The primary objective is to compare both ixekizumab regimens (80 mg every 2 weeks [Q2W] or 80 mg every 4 weeks [Q4W]) versus placebo in patients with active radiographic axial spondyloarthritis (rad-axSpA) at Week 16. Secondary The major secondary objective is:  To compare both ixekizumab regimens (80 mg Q2W or 80 mg Q4W) to placebo at Week 16

Test Drug

Ixekizumab (LY2439821)

Active Ingredient

Ixekizumab (LY2439821)

Dosage Form

Injection

Dosage

80

Endpoints

 Proportion of patients achieving an Assessment of
Spondyloarthritis International Society 40
(ASAS40) response.
 Proportion of patients achieving an ASAS20
response
 Change from baseline in Ankylosing Spondylitis
Disease Activity Score (ASDAS)
 Proportion of patients achieving Bath Ankylosing
Spondylitis Disease Activity Index 50 (BASDAI50)
response
 Change from baseline in Bath Ankylosing
Spondylitis Functional Index (BASFI)
 Proportion of patients achieving ASDAS inactive
disease
 Change from baseline in magnetic resonance
imaging (MRI) of the spine (Ankylosing Spondylitis
Spinal Magnetic Resonance Imaging [ASSpiMRI] –
Berlin score)
 Change from baseline in Short Form 36 (SF-36)
physical component score (PCS)
 Change from baseline in ASAS Health Index
(ASAS HI)

Inclution Criteria

Inclusion Criteria:
• Are ambulatory.
• Diagnosis of radiographic axial spondyloarthritis (rad-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.
• 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 a history of prior therapy for axSpa for at least 12 weeks prior to screening.

Exclusion Criteria

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.

The Estimated Number of Participants

  • Taiwan

    60 participants

  • Global

    320 participants

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