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

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ClinicalTrials.gov Identifier: NCT03129100
Recruitment Status : Active, not recruiting
First Posted : April 26, 2017
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Axial Spondyloarthritis Drug: Ixekizumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 773 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : May 9, 2017
Actual Primary Completion Date : May 26, 2020
Estimated Study Completion Date : September 27, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Ixekizumab

Arm Intervention/treatment
Experimental: Dose Schedule 1 Ixekizumab
Ixekizumab given subcutaneously (SC).
Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Experimental: Dose Schedule 2 Ixekizumab
Ixekizumab given SC.
Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Placebo Comparator: Placebo
Placebo given SC.
Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. Proportion of Participants who do not Experience a Flare (Combined Ixekizumab Treatment) [ Time Frame: Week 64 ]
    Proportion of participants who do not experience a flare


Secondary Outcome Measures :
  1. Change from Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) [ Time Frame: Baseline, 1 Year ]
    Change from baseline in mSASSS

  2. Proportion of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response [ Time Frame: Week 64 ]
    Proportion of participants achieving an ASAS20 response

  3. Proportion of Participants Achieving an ASAS40 Response [ Time Frame: Week 64 ]
    Proportion of participants achieving an ASAS40 response

  4. Proportion of Participants with Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥1.1 Units [ Time Frame: Week 64 ]
    Proportion of participants with change of ASDAS ≥1.1 units

  5. Proportion of Participants with Inactive Disease on the ASDAS (<1.3 Units) [ Time Frame: Week 64 ]
    Proportion of participants with inactive disease on the ASDAS (<1.3 units)

  6. Change from Baseline in the Individual Components of the ASAS Criteria [ Time Frame: Baseline, Week 64 ]
    Change from baseline in the individual components of the ASAS criteria

  7. Proportion of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response [ Time Frame: Week 64 ]
    Proportion of participants achieving BASDAI50 response

  8. Change from Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP) [ Time Frame: Baseline, Week 64 ]
    Change from baseline in the measure of high sensitivity CRP

  9. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Baseline, Week 64 ]
    Change from baseline in BASFI

  10. Change from Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) [ Time Frame: Baseline, Week 64 ]
    Change from baseline in BASMI

  11. Change from Baseline in Chest Expansion in Centimeters [ Time Frame: Baseline, Week 64 ]
    Change from baseline in chest expansion in centimeters

  12. Change from Baseline in Occiput to Wall Distance [ Time Frame: Baseline, Week 64 ]
    Change from baseline in occiput to wall distance

  13. Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) [ Time Frame: Baseline, Week 64 ]
    Change from baseline in MASES

  14. Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score [ Time Frame: Baseline, Week 64 ]
    Change from baseline in SPARCC enthesitis score

  15. Change from Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Score of 46/44 Joints [ Time Frame: Baseline, Week 64 ]
    Change from baseline in severity of peripheral arthritis by TJC score of 46/44 joints

  16. Change from Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Score of 46/44 Joints [ Time Frame: Baseline, Week 64 ]
    Change from baseline in severity of peripheral arthritis by SJC score of 46/44 joints

  17. Proportion of Participants with Anterior Uveitis or Uveitis Flares [ Time Frame: Week 64 ]
    Proportion of participants with anterior uveitis or uveitis flares

  18. Change from Baseline in the Fatigue Numeric Rating Scale (NRS) Score [ Time Frame: Baseline, Week 64 ]
    Change from baseline in the Fatigue NRS score

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

  20. 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 SF-36 PCS score

  21. Change from Baseline in SF-36 Mental Component Summary (MCS) Score [ Time Frame: Baseline, Week 64 ]
    Change from baseline in SF-36 MCS score

  22. Change from Baseline in ASAS-Health Index (ASAS-HI) [ Time Frame: Baseline, Week 64 ]
    Change from baseline in ASAS-HI

  23. Change from Baseline on the European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) [ Time Frame: Baseline, Week 64 ]
    Change from baseline on the EQ-5D-5L

  24. Change from Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores [ Time Frame: Baseline, Week 64 ]
    Change from baseline in the WPAI-SpA scores

  25. Change from Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ) [ Time Frame: Baseline, Week 64 ]
    Change from baseline in the JSEQ

  26. Proportion of Participants with No New Syndesmophyte Formation [ Time Frame: Week 56 ]
    Proportion of participants with no new syndesmophyte formation

  27. Number of Participants with Anti-Ixekizumab Antibodies [ Time Frame: Baseline, Week 64 ]
    Number of participants with anti-ixekizumab antibodies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129100


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03129100    
Other Study ID Numbers: 16181
I1F-MC-RHBY ( Other Identifier: Eli Lilly and Company )
2016-002634-69 ( EudraCT Number )
First Posted: April 26, 2017    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Ixekizumab
Dermatologic Agents