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A Study of Ixekizumab in Participants With Active Psoriatic Arthritis (SPIRIT-P1)

This study is currently recruiting participants.
Verified June 2013 by Eli Lilly and Company
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01695239
First received: September 25, 2012
Last updated: June 14, 2013
Last verified: June 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Psoriasis, Arthritic
 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 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis
Drug Information available for: Adalimumab
U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: American College of Rheumatology 20 Index (ACR20) [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: modified Total Sharp Score (mTSS) [ Time Frame: Baseline through 24 Weeks ] [ Designated as safety issue: No ]
  • Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: ACR20 [ Time Frame: Baseline through 24 Weeks ] [ Designated as safety issue: No ]
  • Efficacy of ixekizumab in participants with active psoriatic arthritis. Measure: Non-Arthritic Disease Assessments [ Time Frame: Baseline through 24 Weeks ] [ Designated as safety issue: No ]
  • Quality of life and outcome assessments. Measures: Patient Reported Outcomes (PRO) [ Time Frame: Baseline through 24 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 412
Study Start Date: December 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: June 2015 (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:

  • Presents with established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
  • Active psoriatic arthritis (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

Exclusion Criteria:

  • Current or prior use of biologic agents for treatment of Ps or PsA
  • Inadequate response to greater than or equal to 4 conventional disease-modifying antirheumatic drugs (DMARDs)
  • Current use of more than one conventional DMARD
  • Evidence of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
  • Have participated in any study with interleukin 17 (IL-17) antagonists, including ixekizumab
  • Serious disorder or illness other than psoriatic arthritis
  • Serious infection within the last 3 months
  • Breastfeeding or nursing (lactating) women
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01695239

Contacts
Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 132 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: NCT01695239     History of Changes
Other Study ID Numbers: 13731, I1F-MC-RHAP
Study First Received: September 25, 2012
Last Updated: June 14, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
France: Ministry of Health
Hungary: National Institute of Pharmacy
Ireland: Irish Medicines Board
Japan: Pharmaceuticals and Medical Devices Agency
Mexico: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
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:
Arthritis
Arthritis, Psoriatic
Psoriasis
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
 Bone Diseases
Skin Diseases, Papulosquamous
Skin Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on June 17, 2013