A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2021
• Main ID: NCT03129100
• Date of registration: 03/04/2017
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis
• Scientific title: A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients With Axial Spondyloarthritis
• Date of first enrolment: May 9, 2017
• Target sample size: 773
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03129100
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 3

Countries of recruitment

Argentina, Austria, Brazil, Canada, Cyprus, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Puerto Rico, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion criteria

Inclusion Criteria:

- Have completed the final study visit in Study RHBV (NCT02696785), RHBW (NCT02696798),
or RHBX (NCT02757352).

(Note: Participants from Study RHBX are not eligible if they permanently discontinued
ixekizumab and were receiving a tumor necrosis factor [TNF] inhibitor).

- Must agree to use a reliable method of birth control.

Exclusion Criteria:

- Have significant uncontrolled disorders or abnormal laboratory values that, in the
opinion of the investigator, pose an unacceptable risk to the participant if
investigational product continues to be administered.

- Have a known hypersensitivity to ixekizumab or any component of this investigational
product.

- Had investigational product permanently discontinued during a previous ixekizumab
study.

- Had temporary investigational product interruption at any time during or at the final
study visit of a previous ixekizumab study and, in the opinion of the investigator,
restarting ixekizumab poses an unacceptable risk for the participant's participation
in the study.

- Have any other condition that, in the opinion of the investigator, renders the
participant unable to understand the nature, scope, and possible consequences of the
study or precludes the participant from following and completing the protocol.

- Are currently enrolled in any other clinical trial involving an investigational
product or any other type of medical research judged not to be scientifically or
medically compatible with this study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Axial Spondyloarthritis

Intervention(s)

Drug: Placebo

Drug: Ixekizumab

Primary Outcome(s)

Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment) [Time Frame: Week 64]

Secondary Outcome(s)

Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response [Time Frame: Week 64]

Percentage of Participants With Anterior Uveitis or Uveitis Flares [Time Frame: Week 64]

Percentage of Participants With Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) =1.1 Units [Time Frame: Week 64]

Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score [Time Frame: Baseline, Week 64]

Percentage of Participants With No New Syndesmophyte Formation [Time Frame: Week 56]

Change From Baseline in ASAS Health Index (ASAS HI) [Time Frame: Baseline, Week 64]

Change From Baseline in Occiput to Wall Distance [Time Frame: Baseline, Week 64]

Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP) [Time Frame: Baseline, Week 64]

Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores [Time Frame: Baseline, Week 64]

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) [Time Frame: Baseline, Week 64]

Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ) [Time Frame: Baseline, Week 64]

Change From Baseline in the European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) UK Population-based Index Score [Time Frame: Baseline, Week 64]

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score [Time Frame: Baseline, Week 64]

Change From Baseline in Chest Expansion in Centimeters [Time Frame: Baseline, Week 64]

Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) [Time Frame: Baseline, Week 64]

Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) [Time Frame: Baseline, 2 Years]

Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response [Time Frame: Week 64]

Percentage of Participants Achieving an ASAS40 Response [Time Frame: Week 64]

Percentage of Participants With Anti-Ixekizumab Antibodies [Time Frame: Baseline, Week 64]

Change From Baseline in SF-36 Mental Component Summary (MCS) Score [Time Frame: Baseline, Week 64]

Change From Baseline in the Individual Components of the ASAS Criteria [Time Frame: Baseline, Week 64]

Change From Baseline on the Quick Inventory of Depressive Symptomatology Self-Report-16 (QIDS-SR16) [Time Frame: Baseline, Week 64]

Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Score of 44 Joints [Time Frame: Baseline, Week 64]

Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Score of 46 Joints [Time Frame: Baseline, Week 64]

Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score [Time Frame: Baseline, Week 64]

Percentage of Participants Who do Not Experience a Flare [Time Frame: Week 64]

Percentage of Participants With Inactive Disease on the ASDAS (<1.3 Units) [Time Frame: Week 64]

Secondary ID(s)

2016-002634-69

16181

I1F-MC-RHBY

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/06/2021
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03129100