Study of Ixekizumab in Participants With Active Ankylosing Spondylitis (AS) (SPIRIT A1)

This study has been withdrawn prior to enrollment.
(Due to unexpected operational issues outside of Lilly's control the study has been closed)
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01870284
First received: June 3, 2013
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Spondylitis, Ankylosing
Drug: Ixekizumab
Drug: Placebo
Drug: Adalimumab
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Efficacy of Ixekizumab in Participants with Ankylosing Spondylitis (AS). Measure: Assessment of SpondyloArthritis International Society Criteria (ASAS20) [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of Ixekizumab in Participants with AS. Measure: ASAS [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
  • Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) [ Time Frame: Baseline through 16 Weeks ] [ Designated as safety issue: No ]
  • Efficacy of Ixekizumab in Participants with AS. Measure: Non-Arthritic Disease Assessments [ Time Frame: Baseline through 16 Weeks ] [ Designated as safety issue: No ]
  • Efficacy of Ixekizumab in Participants with AS. Measure: Peripheral Joint Counts [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
  • Efficacy of Ixekizumab in Participants with AS. Measure: Spinal Mobility [ Time Frame: Baseline through 16 Weeks ] [ Designated as safety issue: No ]
  • Efficacy of Ixekizumab in Participants with AS. Measure: modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) [ Time Frame: Baseline through 108 Weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2014
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ixekizumab Dosing Regimen 1
Administered by 80 milligram (mg) subcutaneous (SC) injection
Drug: Ixekizumab
Administered SC
Other Name: LY2439821
Experimental: Ixekizumab Dosing Regimen 2
Administered by 80 mg SC Injection
Drug: Ixekizumab
Administered SC
Other Name: LY2439821
Placebo Comparator: Placebo
Placebo for ixekizumab and placebo for adalimumab administered by SC injection
Drug: Placebo
Administered SC
Active Comparator: Adalimumab
Administered by 40 mg SC injection
Drug: Adalimumab
Administered SC

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01870284

  Show 126 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01870284     History of Changes
Other Study ID Numbers: 13650, I1F-MC-RHAO
Study First Received: June 3, 2013
Last Updated: January 21, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
France: Ministry of Health
Hungary: National Institute of Pharmacy
Mexico: Ministry of Health
Argentina: Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Office for Radiation Protection
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Russia: Ministry of Health of the Russian Federation
Spain: Spanish Agency of Medicines
Ukraine: State Pharmacological Center - Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Adalimumab
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 11, 2014