NCT02757352

Brief Summary

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).

Trial Health

98
On Track

Trial Health Score

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

Strong global presence with extensive site network
Enrollment
303

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2016

Typical duration for phase_3

Geographic Reach
16 countries

109 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

April 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 2, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

August 2, 2016

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 13, 2020

Completed
Last Updated

March 13, 2020

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

April 28, 2016

Results QC Date

February 28, 2020

Last Update Submit

February 28, 2020

Conditions

Axial Spondyloarthritis

Keywords

ankylosingnonradiographic spondyloarthritis

Outcome Measures

Primary Outcomes (2)

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

    ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain 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. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).

    Week 16

  • Percentage of Participants Achieving an ASAS40 Response

    ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain 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. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).

    Week 52

Secondary Outcomes (27)

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

    Baseline, Week 16

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

    Baseline, Week 52

  • Number of Participants Without Clinically Meaningful Changes in Background Therapy

    Baseline through Week 52

  • Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score

    Baseline, Week 16

  • Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score

    Baseline, Week 52

  • +22 more secondary outcomes

Study Arms (3)

Q2W Ixekizumab

EXPERIMENTAL

Participants received a starting dose of 80 or 160 milligram (mg) of ixekizumab given subcutaneously (SC) at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52 during the double-blind period. Inadequate responders (IR) as determined by investigators could switch to ixekizumab 80 mg Q2W open label between week 16 and 44.

Drug: Ixekizumab

Q4W Ixekizumab

EXPERIMENTAL

Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52 during the double-blind period. Inadequate responders as determined by investigators could switch to ixekizumab 80 mg Q2W open label week 16 and 44.

Drug: Ixekizumab

Placebo

PLACEBO COMPARATOR

Participants received placebo as 2 SC injections Q2W to week 52 during double-blind period. Inadequate responders as determined by investigators could switch to ixekizumab 80 mg Q2W open label between week 16 and 44.

Drug: Placebo

Interventions

IxekizumabDRUG

Administered SC

Also known as: LY2439821
Q2W 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.
  • Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 Assessment of Spondyloarthritis International Society (ASAS) classification criteria.
  • Have a history of back pain ≥3 months with age at onset \<45 years.
  • Have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a numeric rating scale (NRS) at screening and baseline.
  • Have objective signs of inflammation by presence of sacroiliitis on MRI and/or presence of elevated C-reactive protein (CRP).
  • In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
  • If taking NSAIDS be on 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 radiographic sacroiliitis fulfilling the 1984 modified New York criteria.
  • Have received any prior, or are currently receiving treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
  • Have 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.
  • Have evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (109)

Arizona Arthritis Research, PLC

Phoenix, Arizona, 85032, United States

Location

TriWest Research Assocaites

El Cajon, California, 92020, 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

Inlande Rheumatology Clinical Trials

Upland, California, 91786, United States

Location

Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC

Colorado Springs, Colorado, 80920, United States

Location

Clinical Research Center of CT/NY

Danbury, Connecticut, 06810, United States

Location

Sarasota Arthritis Center

Sarasota, Florida, 34239, United States

Location

West Broward Rheumatology Associates, Inc

Tamarac, Florida, 33321, United States

Location

Marietta Rheumatology

Marietta, Georgia, 30060, United States

Location

Institute of Arthritis Research

Idaho Falls, Idaho, 83404, United States

Location

The Arthritis & Diabetes Clinic Inc.

Monroe, Louisiana, 71203, United States

Location

Osteoporosis And Clinical Trial Center

Cumberland, Maryland, 21502, United States

Location

Osteoporosis And Clinical Trial Center

Hagerstown, Maryland, 21740, United States

Location

Glacier View Research Institute

Kalispell, Montana, 59901, United States

Location

Physician Research Collaboration, LLC

Lincoln, Nebraska, 68516, United States

Location

Weill Cornell Physicians at Brooklyn Heights

Brooklyn, New York, 11201, United States

Location

Shanahan Rheumatology & Immunotherapy

Raleigh, North Carolina, 27617, United States

Location

Carolina Arthritis Associates

Wilmington, North Carolina, 28401, 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

Seattle Rheumatology Associates, P.L.L.C.

Seattle, Washington, 98122, United States

Location

Arthritis Northwest Rheumatology

Spokane, Washington, 99204, United States

Location

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Capital Federal, C1430EGF, Argentina

Location

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Ciudad Autonoma de Buenos Aire, C1428DZF, Argentina

Location

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Quilmes, B1878DVC, Argentina

Location

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Rosario, S2000CFJ, Argentina

Location

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Rosario, S2000DEJ, Argentina

Location

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San Juan, J5402DIL, 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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Vienna, 1060, Austria

Location

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Vienna, 1090, Austria

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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Rio de Janeiro, 21941-913, Brazil

Location

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Rio de Janeiro, 22271-100, Brazil

Location

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Québec, G1V 3M7, Canada

Location

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St. John's, A1C 5B8, Canada

Location

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Toronto, M5T 2S8, Canada

Location

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Trois-Rivières, G8Z 1Y2, Canada

Location

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Brno, 611 41, Czechia

Location

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Ostrava, 703 00, Czechia

Location

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Pardubice, 530 02, Czechia

Location

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Prague, 128 50, Czechia

Location

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Uherské Hradiště, 686 01, Czechia

Location

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Helsinki, 00100, Finland

Location

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Helsinki, 00290, Finland

Location

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Hyvinkää, 05800, Finland

Location

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Kuopio, 70110, Finland

Location

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Oulu, 90029, Finland

Location

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Halle, Saxony-Anhalt, 06108, Germany

Location

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Bad Doberan, 18209, Germany

Location

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Berlin, 10117, Germany

Location

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Hamburg, 20095, Germany

Location

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Hamburg, 22081, Germany

Location

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Herne, 44649, Germany

Location

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Bunkyō City, 113-8431, Japan

Location

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Chūōku, 104-8560, Japan

Location

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Kita-gun, 761-0793, Japan

Location

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Kuwana, 511-0061, Japan

Location

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Nankoku, 783-8505, Japan

Location

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Nishinomiya, 663-8501, Japan

Location

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Okayama, 700-8607, Japan

Location

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Osaka, 534-0021, Japan

Location

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Osaka, 545-8586, Japan

Location

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Ōsaka, 5340021, Japan

Location

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Sapporo, 060-8648, Japan

Location

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Sasebo, 857-1195, Japan

Location

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Suita-shi, 565-0871, Japan

Location

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Tenri, 632-8552, 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, 44620, 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, 64460, 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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Elblag, 82-300, Poland

Location

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Lodz, 90-558, Poland

Location

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Nadarzyn, 05-830, 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, 03-291, Poland

Location

Office: Perez-De Jesus, Amarilis

Caguas, PR, 00725, Puerto Rico

Location

Ponce School of Medicine CAIMED Center

Ponce, PR, 00716, Puerto Rico

Location

Mindful Medical Research

San Juan, PR, 00918, Puerto Rico

Location

Latin Clinical Trial Center

Santurce, 00909, Puerto Rico

Location

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Bucharest, 011025, Romania

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

Bucharest, 011172, Romania

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

Constanța, 900591, Romania

Location

V.A. Nasonova Research Institute of Rheumatology

Moscow, 115522, Russia

Location

City Clinical Hospital #1

Moscow, 119049, Russia

Location

Ryazan State Medical University/Ryazan Clinical Regional Cardiological Dispensary

Ryazan, 390026, Russia

Location

Clinical Rheumatology Hospital # 25

Saint Petersburg, 190068, Russia

Location

Saratov Regional Clinical Hospital

Saratov, 410053, Russia

Location

Clinical Hospital for Emergency Care

Yaroslavl, 150003, Russia

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

Daejeon, 35015, 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, 02447, 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, 03080, 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.

Seoul, 05030, 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, 05278, 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, 05505, 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, 06273, South Korea

Location

Related Publications (10)

  • 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, Baraliakos X, Lambert RG, Landewe R, Sandoval D, Carlier H, Lisse J, Li X, Hojnik M, Ostergaard M. Effects of ixekizumab treatment on structural changes in the sacroiliac joint: MRI assessments at 16 weeks in patients with non-radiographic axial spondyloarthritis. Lancet Rheumatol. 2022 Sep;4(9):e626-e634. doi: 10.1016/S2665-9913(22)00185-0. Epub 2022 Aug 9.

    PMID: 38288892DERIVED

  • 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

  • Deodhar A, Mease P, Marzo-Ortega H, Hunter T, Sandoval D, Kronbergs A, Lauzon S, Leung A, Navarro-Compan V. Ixekizumab improves sleep and work productivity in patients with non-radiographic axial spondyloarthritis: results from the COAST-X trial at 52 weeks. BMC Rheumatol. 2021 Sep 25;5(1):50. doi: 10.1186/s41927-021-00218-y.

    PMID: 34560906DERIVED

  • Deodhar A, Mease P, Rahman P, Navarro-Compan V, Marzo-Ortega H, Hunter T, Sandoval D, Kronbergs A, Leon L, Shan M, Leung A, De Vlam K, Strand V. Ixekizumab Improves Patient-Reported Outcomes in Non-Radiographic Axial Spondyloarthritis: Results from the Coast-X Trial. Rheumatol Ther. 2021 Mar;8(1):135-150. doi: 10.1007/s40744-020-00254-z. Epub 2020 Dec 7.

    PMID: 33284423DERIVED

  • Walsh JA, Magrey MN, Baraliakos X, Inui K, Weng MY, Lubrano E, van der Heijde D, Boonen A, Gensler LS, Strand V, Braun J, Hunter T, Li X, Zhu B, Leon L, Calderon DMS, Kiltz U. Improvement of Functioning and Health With Ixekizumab in the Treatment of Active Nonradiographic Axial Spondyloarthritis in a 52-Week, Randomized, Controlled Trial. Arthritis Care Res (Hoboken). 2022 Mar;74(3):451-460. doi: 10.1002/acr.24482. Epub 2022 Jan 26.

    PMID: 33044756DERIVED

  • Deodhar A, van der Heijde D, Gensler LS, Kim TH, Maksymowych WP, Ostergaard M, Poddubnyy D, Marzo-Ortega H, Bessette L, Tomita T, Leung A, Hojnik M, Gallo G, Li X, Adams D, Carlier H, Sieper J; COAST-X Study Group. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020 Jan 4;395(10217):53-64. doi: 10.1016/S0140-6736(19)32971-X. Epub 2019 Dec 5.

    PMID: 31813637DERIVED

Related Links

MeSH Terms

Conditions

Axial Spondyloarthritis

Interventions

ixekizumab

Condition Hierarchy (Ancestors)

SpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

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
GT60
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

April 28, 2016

First Posted

May 2, 2016

Study Start

August 2, 2016

Primary Completion

March 1, 2019

Study Completion

May 7, 2019

Last Updated

March 13, 2020

Results First Posted

March 13, 2020

Record last verified: 2019-08-01

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 European Union (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

AU(2)CA(4)ME(7)BR(4)PL(6)RO(3)KR(8)DE(6)AR(8)US(25)JP(15)NL(1)FI(5)CZ(5)PR(4)RU(6)