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

This study is currently recruiting participants.
Verified April 2014 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: April 21, 2014
Last verified: April 2014
  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:


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: December 2014 (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 116 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: April 21, 2014
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 April 21, 2014