NCT02696798

Brief Summary

The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA).

Trial Health

98
On Track

Trial Health Score

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

Enrollment
316

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Apr 2016

Typical duration for phase_3

Geographic Reach
17 countries

99 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
1 month until next milestone

Study Start

First participant enrolled

April 12, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2018

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2019

Completed
6 months until next milestone

Results Posted

Study results publicly available

October 30, 2019

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

2.1 years

First QC Date

February 26, 2016

Results QC Date

September 24, 2019

Last Update Submit

June 10, 2020

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 (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. 1. Patient Global: How active was your spondylitis on average during the last week? score ranges 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 (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (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 (26)

  • 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 Disease Activity Index (BASDAI)

    Baseline, Week 16

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

    Baseline, Week 16

  • +21 more secondary outcomes

Study Arms (3)

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: Starting dose of 160 mg ixekizumab given SC at week 16 followed by 80 mg ixekizumab given SC Q2W or Q4W from week 16 to week 52.

Drug: IxekizumabDrug: Placebo

Interventions

IxekizumabDRUG

Administered SC

Also known as: LY2439821
PlaceboQ2W IxekizumabQ4W Ixekizumab
PlaceboDRUG

Administered SC

Placebo

Eligibility Criteria

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

You may qualify if:

  • Are ambulatory.
  • Have an established 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.
  • Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.
  • Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
  • 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 never taken a TNF inhibitor medication or have taken more than 2.
  • 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 (99)

Arizona Arthritis Research, PLC

Phoenix, Arizona, 85032, United States

Location

Rheumatology Center of San Diego

Escondido, California, 92025, 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

Clinical Research Center of CT/NY

Danbury, Connecticut, 06810, United States

Location

Arthritis Rheumatic Disease Specialties

Aventura, Florida, 33180, United States

Location

Sarasota Arthritis Center

Sarasota, Florida, 34239, United States

Location

Marietta Rheumatology

Marietta, Georgia, 30060, United States

Location

St Luke's Clinic - Intermountain Orthopaedics

Boise, Idaho, 83702, United States

Location

Institute of Arthritis Research

Idaho Falls, Idaho, 83404, United States

Location

Center for Arthritis & Osteoporosis

Elizabethtown, Kentucky, 42701, United States

Location

Klein and Associates MD, PA

Cumberland, Maryland, 21502, United States

Location

Osteoporosis And Clinical Trial Center

Hagerstown, Maryland, 21740, United States

Location

Arthritis Consultants

St Louis, Missouri, 63141, United States

Location

The Center for Rheumatology

Albany, New York, 12203, United States

Location

Shanahan Rheumatology & Immunotherapy

Raleigh, North Carolina, 27617, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Altoona Center for Clinical Research

Duncansville, Pennsylvania, 16635, 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

Southwest Rheumatology, P.A.

Mesquite, Texas, 75150, United States

Location

Center for Arthritis and Rheumatic Diseases, PC

Chesapeake, Virginia, 23320, United States

Location

Arthritis Northwest Rheumatology

Spokane, Washington, 99204, United States

Location

Rheumatology and Immunotherapy Center

Franklin, Wisconsin, 53132, United States

Location

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Rosario, S2000CFJ, Argentina

Location

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Rosario, S2000DEJ, Argentina

Location

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San Miguel de Tucumán, T4000AXL, Argentina

Location

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San Miguel de Tucumán, T4000BRD, Argentina

Location

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Curitiba, 80440-080, Brazil

Location

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Goiás, 74043-110, Brazil

Location

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Juiz de Fora, 36010-570, Brazil

Location

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Porto Alegre, 90480-000, Brazil

Location

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São Paulo, 01244-030, Brazil

Location

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St. John's, A1C 5B8, Canada

Location

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Trois-Rivières, G8Z 1Y2, Canada

Location

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Victoria, V8V 3M9, Canada

Location

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Helsinki, 00029, Finland

Location

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Hyvinkää, 05800, Finland

Location

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Oulu, 90029, Finland

Location

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Clermont, 63003, France

Location

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Le Kremlin-Bicêtre, 94270, France

Location

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Montpellier, 34295, France

Location

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Orléans, 45100, France

Location

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Paris, 75679, France

Location

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Tours, 37044, France

Location

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Berlin, 10117, Germany

Location

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Ashkelon, 7830604, Israel

Location

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Haifa, 3525408, Israel

Location

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Petah Tikva, 4941492, Israel

Location

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Tel Aviv, 6423906, Israel

Location

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Milan, 20157, Italy

Location

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Reggio Emilia, 42123, Italy

Location

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Roma, 00168, Italy

Location

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Siena, 53100, Italy

Location

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Hyōgo, 663-8501, Japan

Location

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Yamagata, 990-9585, Japan

Location

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Chihuahua City, 31000, Mexico

Location

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Guadalajara, 44650, Mexico

Location

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Mexicali, 21200, Mexico

Location

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Mérida, 97070, Mexico

Location

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Monterrey, 64020, Mexico

Location

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San Luis Potosí City, 78213, Mexico

Location

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Amsterdam, 1105 AZ, Netherlands

Location

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Sneek, 8601 ZK, Netherlands

Location

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Bydgoszcz, 85-168, Poland

Location

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Elblag, 82-300, Poland

Location

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Lodz, 90-558, Poland

Location

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Poznan, 61-397, Poland

Location

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Świdnik, 21-040, Poland

Location

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Warsaw, 01-518, Poland

Location

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Warsaw, 02-691, Poland

Location

Office: Perez-De Jesus, Amarilis

Caguas, PR, 00725, Puerto Rico

Location

GCM Medical Group PSC

San Juan, PR, 00909, Puerto Rico

Location

Mindful Medical Research

San Juan, PR, 00918, Puerto Rico

Location

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Santurce, 00909, Puerto Rico

Location

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Daejeon, 35015, South Korea

Location

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Seoul, 02447, South Korea

Location

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Seoul, 03080, South Korea

Location

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Seoul, 04763, South Korea

Location

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Seoul, 05030, South Korea

Location

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Seoul, 05278, South Korea

Location

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Seoul, 05505, South Korea

Location

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Seoul, 06273, South Korea

Location

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Seoul, 06591, South Korea

Location

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Seoul, 07061, South Korea

Location

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Córdoba, 14004, Spain

Location

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Elche, 03202, Spain

Location

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Madrid, 28007, Spain

Location

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Sabadell, 08208, Spain

Location

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Seville, 41010, Spain

Location

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Basingstoke, RG24 9NA, United Kingdom

Location

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Norwich, NR4 7UY, United Kingdom

Location

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Solihull, B91 3JL, United Kingdom

Location

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Stoke-on-Trent, ST6 7AG, United Kingdom

Location

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Wolverhampton, WV10 0QP, United Kingdom

Location

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Wythenshawe, M23 9LT, United Kingdom

Location

Related Publications (11)

  • 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

  • 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

  • Deodhar A, Poddubnyy D, Pacheco-Tena C, Salvarani C, Lespessailles E, Rahman P, Jarvinen P, Sanchez-Burson J, Gaffney K, Lee EB, Krishnan E, Santisteban S, Li X, Zhao F, Carlier H, Reveille JD; COAST-W Study Group. Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo-Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors. Arthritis Rheumatol. 2019 Apr;71(4):599-611. doi: 10.1002/art.40753. Epub 2019 Mar 8.

    PMID: 30343531DERIVED

Related Links

MeSH Terms

Conditions

SpondylarthritisSpondylitis, Ankylosing

Interventions

ixekizumab

Condition Hierarchy (Ancestors)

SpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesArthritisJoint DiseasesAxial SpondyloarthritisSpondylarthropathiesAnkylosis

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

April 12, 2016

Primary Completion

May 18, 2018

Study Completion

May 3, 2019

Last Updated

June 17, 2020

Results First Posted

October 30, 2019

Record last verified: 2020-06

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

ME(6)FR(6)IT(4)PR(4)JP(2)DE(1)NL(2)KR(10)GB(6)PL(7)BR(5)AR(4)US(27)ES(5)CA(3)FI(3)IL(4)