Spondylitis, AnkylosingPhase 3SPIRIT A1NCT01870284

Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS)

A Phase 3 study testing Ixekizumab and Adalimumab in people with Spondylitis, Ankylosing, run by Eli Lilly and Company at 125 sites in 15 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Spondylitis, Ankylosing
What is being tested?: Ixekizumab and Adalimumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 0 participants
Where: 125 sitesin 15 countries
Study dates: Jul 2014to Apr 2018
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
Have active AS defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and the spinal pain (back pain) score ≥4 on a numeric rating scale (NRS)
Participants should have been on nonsteroidal anti-inflammatory drugs (NSAIDs) with an inadequate response
Participants who are regularly taking NSAIDs or cyclooxygenase-2 (COX-2) inhibitors as part of their AS therapy are required to be on a stable dose
Participants who have been on a tumor necrosis factor alpha (TNF) inhibitor (not more than one) must have experienced an inadequate response
Total duration of prior therapy (NSAIDs and/or adequate physical therapy) should be at least 12 weeks
Men must agree to use a reliable method of birth control or remain abstinent during the study
Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment

Who cannot join

Participants with a total ankylosis of the spine
Prior or current treatment with adalimumab
Participants previously treated with any biological or other immunomodulating agents except for those targeting TNF
Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than ankylosing spondylitis
Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
Serious disorder or illness other than ankylosing spondylitis
Serious infection within the last 3 months
Breastfeeding or nursing (lactating) women

Trial locations and contacts

125 sites in 15 countries.

Country

City, postcode or hospital

125 sites in 15 countries

United States34 sites

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Albany, New York, 12206
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Ann Arbor, Michigan, 48109
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Asheville, North Carolina, 28803
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Atlanta, Georgia, 30342
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Birmingham, Alabama, 35205
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Boise, Idaho, 83704
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Brooklyn, New York, 11201
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Cedar Rapids, Iowa, 52401
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Charleston, South Carolina, 29407
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Charlotte, North Carolina, 28210
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Columbia, South Carolina, 29204
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Cumberland, Maryland, 21502
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Dallas, Texas, 75231
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Decatur, Georgia, 30033
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Denver, Colorado, 80230
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Hagerstown, Maryland, 21740
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Hixon, Tennessee, 37343
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Houston, Texas, 77036
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Idaho Falls, Idaho, 83404
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Jackson, Tennessee, 38305
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Kennewick, Washington, 99336
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Lake Oswego, Oregon, 97035
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Little Rock, Arkansas, 72205
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Marietta, Georgia, 30060
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Mineola, New York, 11501
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North Charleston, South Carolina, 29406
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Portland, Oregon, 97239
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Seattle, Washington, 98104
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Tampa, Florida, 33609
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Toledo, Ohio, 43606
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Trumbull, Connecticut, 06611
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Upland, California, 91786
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Wichita, Kansas, 67207
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Worcester, Massachusetts, 01605

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Russia9 sites

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Barnaul, 656024
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Kazan', 420097
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Krasnoyarsk, 660022
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Moscow
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Novosibirsk, 630099
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Petrozavodsk, 185019
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Ryazan, 390026
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Saint Petersburg, 194291
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Yekaterinburg, 620102

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Spain9 sites

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A Coruña, 15006
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Barcelona, 08034
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Bilbao, 48013
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Córdoba, 14004
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Madrid, 28007
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Málaga, 29009
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Oviedo, 33012
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Santander, 39008
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Seville, 41009

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Ukraine9 sites

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Dnipropetrovsk, 49044
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Donetsk, 83045
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Ivano-Frankivsk, 76018
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Kharkiv, 61039
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Kyiv, 1601
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Lutsk, 43024
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Odesa, 65026
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Vinnytsia, 21018
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Zaporizhzhya, 69600

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France8 sites

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Amiens, 80054
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Bordeaux, 33076
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Montpellier, 34295
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Nantes, 44093
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Orléans, 45032
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Paris, 75679
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Rennes, 35202
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Strasbourg, 67098

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Netherlands7 sites

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Amsterdam, 1105 AZ
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Breda, 4818 CK
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Leiden, 2333 ZA
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Maastricht, 6229 HX
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Nijmegen, 6522 JV
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Rotterdam, 3079 DZ
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Sneek, 8601 ZK

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United Kingdom7 sites

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Bradford, West Yorkshire, BD5 0NA
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Coventry, West Midlands, CV2 2DX
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Leeds, West Yorkshire, LS7 4SA
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London, Greater London, E11 1NR
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Norwich, Norfolk, NR4 7UY
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Southampton, Hants, SO16 6YD
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Wolverhampton, West Midlands, WV10 0QP

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Canada6 sites

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Edmonton, Alberta, T6G 2R7
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Québec, Quebec, G1W 4R4
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Rimouski, Quebec, G5L 8W1
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Sainte-Foy, Quebec, G1V 3M7
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Toronto, Ontario, M5T 2S8
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Winnipeg, Manitoba, R3N 0K6

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Brno, 638 00
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Bruntál, 79201
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Kladno, 272 01
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Ostrava - Trebovice, 722 00
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Prague, 140 00
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Zlín, 760 01

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Hungary6 sites

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Balatonfüred, 8230
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Budapest, 1036
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Debrecen, 4032
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Kalocsa, H-6300
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Nyíregyháza, 4400
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Veszprém, 8200

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Poland6 sites

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Katowice, 40-635
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Krakow, 31-501
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Lublin, 20582
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Poznan, 60-539
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Warsaw, 02-118
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Bad Doberan, 18209
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Berlin, 12203
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Halle, 06108
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Heidelberg, 69121
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Ratingen, 40882

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Mexico5 sites

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Guadalajara, 45040
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Mexico City, 06700
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Monterrey, 64000
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Morelia, 58249
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San Luis, 78200

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Buenos Aires, C1428DQG
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Caba, 1181
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Córdoba, X5004BAL
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San Miguel de Tucumán, T4000AXL

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Genk, 3600
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Ghent, 9000
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Liège, 4000
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Mons, 7000

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About this study

Official title: A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients With Active Ankylosing Spondylitis

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS.

Conditions: Spondylitis, Ankylosing
Being tested: Ixekizumab, Placebo, Adalimumab
Medical subject headings: Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IxekizumabDrug
Also called LY2439821
Administered SC
PlaceboDrug
Administered SC
AdalimumabDrug
Administered SC

Study groups in NCT01870284
Study group	Role	What they receive
Ixekizumab Dosing Regimen 1	Experimental	Administered by 80 milligram (mg) subcutaneous (SC) injection Receives: Drug: Ixekizumab
Ixekizumab Dosing Regimen 2	Experimental	Administered by 80 mg SC Injection Receives: Drug: Ixekizumab
Placebo	Placebo comparator	Placebo for ixekizumab and placebo for adalimumab administered by SC injection Receives: Drug: Placebo
Adalimumab	Active comparator	Administered by 40 mg SC injection Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy of Ixekizumab in Participants with Ankylosing Spondylitis (AS). Measure: Assessment of SpondyloArthritis International Society Criteria (ASAS20)
Measured: 16 Weeks

Secondary outcomes (6)

Efficacy of Ixekizumab in Participants with AS. Measure: ASAS
Measured: 16 Weeks
Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)
Measured: Baseline through 16 Weeks
Efficacy of Ixekizumab in Participants with AS. Measure: Non-Arthritic Disease Assessments
Measured: Baseline through 16 Weeks
Efficacy of Ixekizumab in Participants with AS. Measure: Peripheral Joint Counts
Measured: 16 Weeks
Efficacy of Ixekizumab in Participants with AS. Measure: Spinal Mobility
Measured: Baseline through 16 Weeks
Efficacy of Ixekizumab in Participants with AS. Measure: modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)
Measured: Baseline through 108 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Apr 2018

First posted6 Jun 2013 (estimated)
Study startJul 2014
Primary completionApr 2016 (estimated)
Study completionApr 2018 (estimated)

Why it stopped: Due to unexpected operational issues outside of Lilly's control the study has been closed

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Spondylitis, AnkylosingStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01870284
Sponsor's protocol ID: 13650
Other IDs: I1F-MC-RHAO
Acronym: SPIRIT A1
Status last verified: Sep 2014
First submitted: 3 Jun 2013
Last updated: 16 Sep 2014
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis

All Spondylitis, Ankylosing trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Patients With Active Ankylosing Spondylitis
ClinicalTrials.gov ID: NCT01870284
Acronym / sponsor ID: SPIRIT A1 / 13650
Conditions: Spondylitis, Ankylosing
Phase: Phase 3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Due to unexpected operational issues outside of Lilly's control the study has been closed
Enrolment: 0 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Apr 2016 (estimated)
Study completion: Apr 2018 (estimated)
First posted: 6 Jun 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will assess the safety and efficacy of ixekizumab (LY2439821) compared to placebo in participants with active AS.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Ixekizumab Dosing Regimen 1	Experimental	Drug: IxekizumabAdministered by 80 milligram (mg) subcutaneous (SC) injection
Ixekizumab Dosing Regimen 2	Experimental	Drug: IxekizumabAdministered by 80 mg SC Injection
Placebo	Placebo comparator	Drug: PlaceboPlacebo for ixekizumab and placebo for adalimumab administered by SC injection
Adalimumab	Active comparator	Drug: AdalimumabAdministered by 40 mg SC injection

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Diagnosis of moderate to severe AS with prior documented radiologic evidence (X-ray) fulfilling the Modified New York criteria for AS (1984)
Have active AS defined as Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 and the spinal pain (back pain) score ≥4 on a numeric rating scale (NRS)
Participants should have been on nonsteroidal anti-inflammatory drugs (NSAIDs) with an inadequate response
Participants who are regularly taking NSAIDs or cyclooxygenase-2 (COX-2) inhibitors as part of their AS therapy are required to be on a stable dose
Participants who have been on a tumor necrosis factor alpha (TNF) inhibitor (not more than one) must have experienced an inadequate response

Key exclusion criteria (8 listed)

Participants with a total ankylosis of the spine
Prior or current treatment with adalimumab
Participants previously treated with any biological or other immunomodulating agents except for those targeting TNF
Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than ankylosing spondylitis
Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IxekizumabAlso: LY2439821Administered SC	Drug	Ixekizumab Dosing Regimen 1, Ixekizumab Dosing Regimen 2
PlaceboAdministered SC	Drug	Placebo
AdalimumabAdministered SC	Drug	Adalimumab

Primary outcome

Efficacy of Ixekizumab in Participants with Ankylosing Spondylitis (AS). Measure: Assessment of SpondyloArthritis International Society Criteria (ASAS20)
Time frame: 16 Weeks

6 secondary outcomes

Efficacy of Ixekizumab in Participants with AS. Measure: ASAS
Time frame: 16 Weeks
Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)
Time frame: Baseline through 16 Weeks
Efficacy of Ixekizumab in Participants with AS. Measure: Non-Arthritic Disease Assessments
Time frame: Baseline through 16 Weeks
Efficacy of Ixekizumab in Participants with AS. Measure: Peripheral Joint Counts
Time frame: 16 Weeks
Efficacy of Ixekizumab in Participants with AS. Measure: Spinal Mobility
Time frame: Baseline through 16 Weeks
Efficacy of Ixekizumab in Participants with AS. Measure: modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)
Time frame: Baseline through 108 Weeks

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.

Related trials for Spondylitis, Ankylosing

RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Not yet recruitingPhase 1
A Study of GKL-006Allo Injection in Patients With Ankylosing Spondylitis
Ankylosing Spondylitis
Active, not recruitingObservational study
Neuropathic Spinal Pain in Ankylosing Spondylitis
Ankylosing Spondylitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

125 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ixekizumab and Adalimumab in people with Spondylitis, Ankylosing, run by Eli Lilly and Company at 125 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States, Russia, Spain, Ukraine, France and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy of Ixekizumab in Participants with Ankylosing Spondylitis (AS). Measure: Assessment of SpondyloArthritis International Society Criteria (ASAS20) (time frame: 16 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01870284.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2014.