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A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis (SPIRIT-P2)
This study is ongoing, but not recruiting participants.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT02349295
First received: October 10, 2014
Last updated: October 5, 2016
Last verified: October 2016
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Purpose
The main purpose of this study is to evaluate how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.
| Condition | Intervention | Phase |
|---|---|---|
| Psoriatic Arthritis | Drug: Ixekizumab Drug: Placebo | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-Blind, Placebo Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Experienced Patients With Active Psoriatic Arthritis |
Resource links provided by NLM:
Genetics Home Reference related topics:
psoriatic arthritis
Drug Information available for:
Ixekizumab
U.S. FDA Resources
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20) [ Time Frame: Week 24 ]
Secondary Outcome Measures:
- Change from Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Scores [ Time Frame: Baseline, Week 24 ]
- Proportion of Participants with Psoriasis Area and Severity Index (PASI) 75 [ Time Frame: Week 12 ]
- Percentage of Participants Achieving ACR20 [ Time Frame: Week 12 and Week 52 and up to 3 Years ]
- Percentage of Participants Achieving ACR 50/70 [ Time Frame: Week 24 and Week 52 and up to 3 Years ]
- Change from Baseline in Leeds Enthesitis Index (LEI) [ Time Frame: Baseline, Week 12 ]
- Change from Baseline in Itch Numeric Rating Scale (NRS) [ Time Frame: Baseline, Week 12 ]
- Change from Baseline in Tender Joint Count (TJC) [ Time Frame: Baseline, Week 24 ]
- Change from Baseline in Swollen Joint Count (SJC) [ Time Frame: Baseline, Week 24 ]
- Change from Baseline in Participants Assessment of Pain Visual Analog Scale (VAS) [ Time Frame: Baseline, Week 24 ]
- Change from Baseline in Participants Global Assessment of Disease Activity VAS [ Time Frame: Baseline, Week 24 ]
- Change from Baseline in Physicians Global Assessment of Disease Activity VAS [ Time Frame: Baseline, Week 24 ]
- Change from Baseline in C-Reactive Protein (CRP) [ Time Frame: Baseline, Week 24 ]
- Change from Baseline in Disease Activity Score-CRP (DAS28-CRP) [ Time Frame: Baseline, Week 24 ]
- Change from Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score [ Time Frame: Baseline, Week 24 ]
- Change from Baseline in Fatigue Severity NRS Score [ Time Frame: Baseline, Week 24 ]
- Change from Baseline in 36-Item Short-Form Health Survey (SF-36) Scores [ Time Frame: Baseline, Week 24 ]
- Number of Participants with Anti-Ixekizumab Antibodies [ Time Frame: Week 24 ]
- Pharmacokinetics (PK): Steady State Concentration of Ixekizumab [ Time Frame: Week 24 ]
| Estimated Enrollment: | 360 |
| Study Start Date: | December 2014 |
| Estimated Study Completion Date: | June 2019 |
| Primary Completion Date: | September 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 administered by SC injection.
|
Drug: Placebo
Administered SC
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
- Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
- Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)
- 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
- Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
Exclusion Criteria:
- Current use of biologic agents for treatment of Ps or PsA
- Inadequate response to greater than 2 biologic DMARDs
- Current use of more than one cDMARDs
- Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
- Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
- Serious disorder or illness other than psoriatic arthritis
- 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: NCT02349295
Show 115 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02349295
Show 115 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
Additional Information:
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT02349295 History of Changes |
| Other Study ID Numbers: |
14310 I1F-MC-RHBE ( Other Identifier: Eli Lilly and Company ) 2011-002328-42 ( EudraCT Number ) |
| Study First Received: | October 10, 2014 |
| Last Updated: | October 5, 2016 |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Psoriatic Joint Diseases Musculoskeletal Diseases Spondylarthropathies Spondylarthritis Spondylitis |
Spinal Diseases Bone Diseases Psoriasis Skin Diseases, Papulosquamous Skin Diseases Antirheumatic Agents |
ClinicalTrials.gov processed this record on July 17, 2017