Phase 3 N=773 Randomized Triple-blind Treatment

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

Axial Spondyloarthritis

Bottom Line

View on ClinicalTrials.gov: NCT03129100 ↗

Enrolled (actual)

773

Serious AEs

2.6%

Results posted

Jun 2021

Primary outcome: Primary: Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment) — 83.3; 54.7 Percentage of participants — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Ixekizumab (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: May 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment)	83.3; 54.7	<0.001 sig
SECONDARY Percentage of Participants Who do Not Experience a Flare	83.3; 83.3; 54.7	0.003 sig
SECONDARY Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)	0.41; 0.23; 0.32	—
SECONDARY Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response	81.3; 81.5; 50.9	0.001 sig
SECONDARY Percentage of Participants Achieving an ASAS40 Response	79.2; 79.6; 43.4	<0.001 sig
SECONDARY Percentage of Participants With Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥1.1 Units	79.2; 74.1; 45.3	<0.001 sig
SECONDARY Percentage of Participants With Inactive Disease on the ASDAS (<1.3 Units)	60.4; 53.7; 24.5	<0.001 sig
SECONDARY Change From Baseline in the Individual Components of the ASAS Criteria	-5.1; -5.0; -3.0; -5.1; -4.8; -3.0	<0.001 sig
SECONDARY Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response	81.3; 75.9; 45.3	<0.001 sig
SECONDARY Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)	-12.952; -11.074; -5.094	<0.001 sig
SECONDARY Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)	-0.69; -0.73; -0.50	0.062
SECONDARY Change From Baseline in Chest Expansion in Centimeters	0.77; 0.53; 0.67	0.757
SECONDARY Change From Baseline in Occiput to Wall Distance	-0.78; -0.66; -0.38	0.236
SECONDARY Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)	-3.55; -3.62; -3.48	0.885
SECONDARY Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score	-3.23; -3.34; -2.71	0.294
SECONDARY Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Score of 46 Joints	-6.1; -5.3; -4.0	0.063
SECONDARY Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Score of 44 Joints	-3.6; -3.9; -2.7	0.334
SECONDARY Percentage of Participants With Anterior Uveitis or Uveitis Flares	4.2; 5.6; 5.7	—
SECONDARY Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score	-4.2; -4.3; -3.5	0.100
SECONDARY Change From Baseline on the Quick Inventory of Depressive Symptomatology Self-Report-16 (QIDS-SR16)	-3.68; -3.28; -2.80	0.068
SECONDARY Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score	13.2954; 13.1030; 10.6934	0.079
SECONDARY Change From Baseline in SF-36 Mental Component Summary (MCS) Score	3.1766; 4.6404; 2.3396	0.477
SECONDARY Change From Baseline in ASAS Health Index (ASAS HI)	-4.64; -4.37; -3.64	0.058
SECONDARY Change From Baseline in the European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) UK Population-based Index Score	0.2877; 0.2847; 0.2459	0.213
SECONDARY Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores	-43.58; -40.10; -32.96	0.017 sig
SECONDARY Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)	-4.0; -3.8; -3.6	0.531
SECONDARY Percentage of Participants With No New Syndesmophyte Formation	80.9; 87.8	—
SECONDARY Percentage of Participants With Anti-Ixekizumab Antibodies	4.7; 2.0; 20.0	—

Summary

The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03129100). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.