NCT02696785

Brief Summary

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive participants with radiographic axial spondyloarthritis (rad-axSpA).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
341

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2016

Geographic Reach
7 countries

28 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

May 2, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

November 19, 2019

Completed
Last Updated

November 19, 2019

Status Verified

November 1, 2018

Enrollment Period

1.6 years

First QC Date

February 26, 2016

Results QC Date

September 24, 2019

Last Update Submit

October 31, 2019

Conditions

Spondyloarthritis

Keywords

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response

    ASAS40 is defined as improvement from baseline of greater than or equal to (\>=) 40% and absolute improvement from baseline of at least 2 units in at least 3 of the following 4 domains without any worsening in the remaining domains. 1. Patient Global: How active was your spondylitis on average during the last week? score range 0 (not active) to 10 (very active). 2. Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3. Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using numeric rating scale (NRS) scale (range 0 to 10) with a higher score indicating worse function. 4. Inflammation based on Q5 \& Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity \& duration of stiffness): Score ranges from "0" (none) and "10" (very severe).

    Week 16

Secondary Outcomes (25)

  • Percentage of Participants Achieving an ASAS20 Response

    Week 16

  • Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)

    Baseline, Week 16

  • Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response

    Week 16

  • Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

    Baseline, Week 16

  • Percentage of Participants Achieving ASDAS Inactive Disease

    Week 16

  • +20 more secondary outcomes

Study Arms (4)

Q2W Ixekizumab

EXPERIMENTAL

Double Blind Period: Starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 14. Extended Treatment Period: 80 mg ixekizumab given SC Q2W from week 16 to week 52.

Drug: Ixekizumab

Q4W Ixekizumab

EXPERIMENTAL

Double Blind Period: Starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 14. Extended Treatment Period: 80 mg ixekizumab given SC Q4W from week 16 to week 52.

Drug: Ixekizumab

Placebo

PLACEBO COMPARATOR

Double Blind Period: Placebo given SC Q2W to week 14. Extended Treatment Period: 80 mg ixekizumab given SC Q2W or Q4W from week 16 to week 52.

Drug: IxekizumabDrug: Placebo

Adalimumab

ACTIVE COMPARATOR

Double Blind Period: 40 mg Adalimumab given SC Q2W to week 14. Extended Treatment Period: 80 mg ixekizumab given SC Q2W or Q4W from week 20 to week 52.

Drug: IxekizumabDrug: Adalimumab

Interventions

IxekizumabDRUG

Administered SC

Also known as: LY2439821
AdalimumabPlaceboQ2W IxekizumabQ4W Ixekizumab
PlaceboDRUG

Administered SC

Placebo
AdalimumabDRUG

Administered SC

Adalimumab

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (28)

Arizona Arthritis Research, PLC

Phoenix, Arizona, 85032, United States

Location

Care Access Research - Huntington Beach

Huntington Beach, California, 92648, United States

Location

Desert Medical Advances

Palm Desert, California, 92260, United States

Location

Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC

Colorado Springs, Colorado, 80920, United States

Location

Denver Arthritis Center

Denver, Colorado, 80230, United States

Location

New England Research Associates

Trumbull, Connecticut, 06611, United States

Location

Sarasota Arthritis Center

Sarasota, Florida, 34239, United States

Location

Marietta Rheumatology

Marietta, Georgia, 30060, United States

Location

Center for Arthritis & Osteoporosis

Elizabethtown, Kentucky, 42701, United States

Location

Klein and Associates MD, PA

Cumberland, Maryland, 21502, United States

Location

Klein and Associates MD, PA

Hagerstown, Maryland, 21740, United States

Location

Arthritis Consultants

St Louis, Missouri, 63141, United States

Location

Glacier View Research Institute

Kalispell, Montana, 59901, United States

Location

Physician Research Collaboration, LLC

Lincoln, Nebraska, 68516, United States

Location

Shanahan Rheumatology & Immunotherapy

Raleigh, North Carolina, 27617, United States

Location

Articularis Healthcare Group, INC dba Columbia Arthritis Ctr

Columbia, South Carolina, 29204, United States

Location

Low Country Research Center

North Charleston, South Carolina, 29406, United States

Location

Univ of Texas Health Science Center - Houston

Houston, Texas, 77030, United States

Location

Arthritis Northwest Rheumatology

Spokane, Washington, 99204, United States

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Brno, 611 41, Czechia

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Berlin, 12203, Germany

Location

"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Hyōgo, 366 8501, Japan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Warszawa, 02-691, Netherlands

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Gwangjin-gu, 05080, South Korea

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Seoul, 04763, South Korea

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Taichung, 40201, Taiwan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Taichung, 40447, Taiwan

Location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Taipei, 10048, Taiwan

Location

Related Publications (14)

  • Reveille JD, Rudwaleit M, Rahman P, Maldonado-Cocco JA, Magrey M, Bolce R, Ng KJ, Gibble TH, Lisse J, Park SY, Kronbergs A, Navarro-Compan V. Does HLA-B27 Status Influence Ixekizumab Efficacy in Axial Spondyloarthritis? Results From the COAST-V, COAST-W, and COAST-X Trials. Rheumatol Ther. 2026 Feb;13(1):279-291. doi: 10.1007/s40744-025-00810-5. Epub 2025 Dec 19.

    PMID: 41417207DERIVED

  • Navarro-Compan V, Reveille JD, Rahman P, Maldonado-Cocco JA, Magrey M, Bolce R, Panni T, Kronbergs A, Rudwaleit M. Ixekizumab Improves Signs, Symptoms, and Quality of Life in Patients with Axial Spondyloarthritis Irrespective of Symptom Duration. Adv Ther. 2025 Sep;42(9):4706-4716. doi: 10.1007/s12325-025-03305-5. Epub 2025 Jul 22.

    PMID: 40694276DERIVED

  • Maksymowych WP, Lambert RGW, Bolce RJ, Bello N, Zhu B, Lisse JR, Ostergaard M. The effect of ixekizumab treatment on MRI sacroiliac joint structural lesions in patients with radiographic axial spondyloarthritis: post-hoc analysis of a 52-week, randomised, placebo-controlled trial with an active reference arm. Lancet Rheumatol. 2025 May;7(5):e314-e322. doi: 10.1016/S2665-9913(24)00312-6. Epub 2025 Feb 18.

    PMID: 39983751DERIVED

  • Ramiro S, Lukas C, Nissen MJ, Zhu B, Ng KJ, Sheesh M, Doridot G, Liu-Leage S, Chan A, Fang Y, Wei JC. Improvement in spinal pain at night and its impact on long-term outcomes in radiographic axial spondyloarthritis: Results from Ixekizumab COAST-V randomised trial. Semin Arthritis Rheum. 2024 Dec;69:152571. doi: 10.1016/j.semarthrit.2024.152571. Epub 2024 Oct 23.

    PMID: 39509838DERIVED

  • Ramiro S, Lukas C, Bessette L, Wickersham P, Panni T, Bolce R, Liu-Leage S, Janos B, Nissen MJ, Wei JC. Early clinical response associates with long-term outcomes with ixekizumab in radiographic axial spondyloarthritis. RMD Open. 2024 Jul 14;10(3):e004429. doi: 10.1136/rmdopen-2024-004429.

    PMID: 39004432DERIVED

  • de Vlam K, Maksymowych WP, Gallo G, Rahman P, Mease P, Krishnan V, McVeigh CJ, Lisse J, Zhu D, Bolce RJ, Conaghan PG. Exploring the Effects of Ixekizumab on Pain in Patients with Ankylosing Spondylitis Based on Objective Measures of Inflammation: Post Hoc Analysis from a Large Randomized Clinical Trial. Rheumatol Ther. 2024 Jun;11(3):691-707. doi: 10.1007/s40744-024-00660-7. Epub 2024 Apr 18.

    PMID: 38637464DERIVED

  • Deodhar A, Poddubnyy D, Rahman P, Ermann J, Tomita T, Bolce R, Leage SL, Kronbergs A, Johnson C, Araujo J, Leung A, van der Heijde D. Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program. J Rheumatol. 2023 Aug;50(8):1020-1028. doi: 10.3899/jrheum.221022. Epub 2023 Feb 15.

    PMID: 36792107DERIVED

  • Ortolan A, Ramiro S, Ramonda R, van der Heijde D. External validation of the alternative Ankylosing Spondylitis Disease Activity Score in three randomized clinical trials of ixekizumab. Rheumatology (Oxford). 2023 Jun 1;62(6):2257-2261. doi: 10.1093/rheumatology/keac618.

    PMID: 36282526DERIVED

  • van der Horst-Bruinsma IE, de Vlam K, Walsh JA, Bolce R, Hunter T, Sandoval D, Zhu D, Geneus V, Soriano ER, Magrey M. Baseline Characteristics and Treatment Response to Ixekizumab Categorised by Sex in Radiographic and Non-radiographic Axial Spondylarthritis Through 52 Weeks: Data from Three Phase III Randomised Controlled Trials. Adv Ther. 2022 Jun;39(6):2806-2819. doi: 10.1007/s12325-022-02132-2. Epub 2022 Apr 16.

    PMID: 35429281DERIVED

  • Maksymowych WP, Bolce R, Gallo G, Seem E, Geneus VJ, Sandoval DM, Ostergaard M, Tada K, Baraliakos X, Deodhar A, Gensler LS. Ixekizumab in radiographic axial spondyloarthritis with and without elevated C-reactive protein or positive magnetic resonance imaging. Rheumatology (Oxford). 2022 Nov 2;61(11):4324-4334. doi: 10.1093/rheumatology/keac104.

    PMID: 35188180DERIVED

  • van der Heijde D, Ostergaard M, Reveille JD, Baraliakos X, Kronbergs A, Sandoval DM, Li X, Carlier H, Adams DH, Maksymowych WP. Spinal Radiographic Progression and Predictors of Progression in Patients With Radiographic Axial Spondyloarthritis Receiving Ixekizumab Over 2 Years. J Rheumatol. 2022 Mar;49(3):265-273. doi: 10.3899/jrheum.210471. Epub 2021 Dec 1.

    PMID: 34853086DERIVED

  • Deodhar AA, Mease PJ, Rahman P, Navarro-Compan V, Strand V, Hunter T, Bolce R, Leon L, Lauzon S, Marzo-Ortega H. Ixekizumab improves spinal pain, function, fatigue, stiffness, and sleep in radiographic axial Spondyloarthritis: COAST-V/W 52-week results. BMC Rheumatol. 2021 Sep 20;5(1):35. doi: 10.1186/s41927-021-00205-3.

    PMID: 34538257DERIVED

  • Dougados M, Wei JC, Landewe R, Sieper J, Baraliakos X, Van den Bosch F, Maksymowych WP, Ermann J, Walsh JA, Tomita T, Deodhar A, van der Heijde D, Li X, Zhao F, Bertram CC, Gallo G, Carlier H, Gensler LS; COAST-V and COAST-W Study Groups. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W). Ann Rheum Dis. 2020 Feb;79(2):176-185. doi: 10.1136/annrheumdis-2019-216118. Epub 2019 Nov 4.

    PMID: 31685553DERIVED

  • Mease P, Walsh JA, Baraliakos X, Inman R, de Vlam K, Wei JC, Hunter T, Gallo G, Sandoval D, Zhao F, Dong Y, Bolce R, Marzo-Ortega H. Translating Improvements with Ixekizumab in Clinical Trial Outcomes into Clinical Practice: ASAS40, Pain, Fatigue, and Sleep in Ankylosing Spondylitis. Rheumatol Ther. 2019 Sep;6(3):435-450. doi: 10.1007/s40744-019-0165-3. Epub 2019 Jun 28.

    PMID: 31254223DERIVED

Related Links

MeSH Terms

Conditions

SpondylarthritisSpondylitis, Ankylosing

Interventions

ixekizumabAdalimumab

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesAxial SpondyloarthritisSpondylarthropathiesAnkylosis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Chief Medical Officer
Organization
Eli Lilly and Company
ClinicalTrials.gov@lilly.com
800-545-5979

Study Officials

  • 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

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2016

First Posted

March 2, 2016

Study Start

May 2, 2016

Primary Completion

December 8, 2017

Study Completion

October 17, 2018

Last Updated

November 19, 2019

Results First Posted

November 19, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, 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.
More information

Locations

US(19)JP(1)KR(2)DE(1)NL(1)TW(3)CZ(1)