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Trial record 7 of 29 for:    LY2439821

A Long-Term Efficacy and Safety Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis (SPIRIT P3)

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ClinicalTrials.gov Identifier: NCT02584855
Recruitment Status : Completed
First Posted : October 23, 2015
Last Update Posted : November 6, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to evaluate the safety and long-term efficacy of ixekizumab compared to placebo in participants with active psoriatic arthritis.

Condition or disease Intervention/treatment Phase
Psoriatic Arthritis Drug: Ixekizumab Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 570 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter Study With a 36-Week Open-Label Period Followed by a Randomized Double-Blind Withdrawal Period From Week 36 to Week 104 to Evaluate the Long-Term Efficacy and Safety of Ixekizumab (LY2439821) 80 mg Every 2 Weeks in Biologic Disease-Modifying Antirheumatic Drug-Naive Patients With Active Psoriatic Arthritis
Actual Study Start Date : September 14, 2015
Actual Primary Completion Date : October 30, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Ixekizumab

Arm Intervention/treatment
Experimental: Ixekizumab

Open Label Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36).

Double Blind Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104.

Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Placebo Comparator: Placebo

Open Label Period: Starting dose of 160 mg ixekizumab given as two SC injections at baseline followed by 80 mg given as one SC injection Q2W from week 2 to randomization (week 36).

Double Blind Period: Placebo given as one SC injection Q2W any time from randomization to week 104.

Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Drug: Placebo
Administered SC

Experimental: Ixekizumab Open Label
Open Label Period: Starting dose of 160 mg ixekizumab given as two SC injections at baseline followed by 80 mg given as one SC injection Q2W from week 2 to week 104.
Drug: Ixekizumab
Administered SC
Other Name: LY2439821




Primary Outcome Measures :
  1. Time to Relapse [No Longer Meeting Coates Criteria for Minimal Disease Activity (MDA)] [ Time Frame: Double Blind Randomization through Relapse in MDA (Estimated Up To 68 Weeks) ]

Secondary Outcome Measures :
  1. Proportion of Participants Who Relapse in MDA [ Time Frame: Double Blind Randomization through Relapse in MDA (Estimated Up To 68 Weeks) ]
  2. Time to Loss of Response in MDA [ Time Frame: Double Blind Randomization through Loss of Response in MDA (Estimated Up To 68 Weeks) ]
  3. Time to First Achieving MDA [ Time Frame: Open Label Baseline through First Achieving MDA (Estimated Up To 36 Weeks) ]
  4. Time to Re-Gain MDA Following Relapse in MDA [ Time Frame: Relapse in MDA After Double Blind Randomization Until Re-Gain MDA (Estimated Up To 64 Weeks) ]
  5. Change from Baseline in Physical Functioning Assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: Baseline, Week 104 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584855


  Show 106 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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02584855     History of Changes
Other Study ID Numbers: 14518
I1F-MC-RHBF ( Other Identifier: Eli Lilly and Company )
2015-002433-22 ( EudraCT Number )
First Posted: October 23, 2015    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018

Keywords provided by Eli Lilly and Company:
Spondyloarthritis
Spondylarthropathy

Additional relevant MeSH terms:
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ixekizumab
Antirheumatic Agents
Dermatologic Agents