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

Lilly

Status and phase: Completed; Phase 3

Conditions: Psoriatic Arthritis

Treatments: Drug: Ixekizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02584855

2015-002433-22 (EudraCT Number)

I1F-MC-RHBF (Other Identifier)

14518

Details and patient eligibility

About

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.

Enrollment: 394 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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394 participants in 4 patient groups, including a placebo group

Ixekizumab Open Label

Experimental group

Description:

Open-Label Treatment Period: Starting dose of 160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at baseline (week 0) followed by 80 mg given as one SC injection every two weeks (Q2W) from week 2 to randomization (week 36 to 64).

Treatment:

Drug: Ixekizumab

Ixekizumab

Experimental group

Description:

Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: 80 mg ixekizumab given as one SC injection Q2W from randomization to week 104 (or, early termination or relapse).

Treatment:

Drug: Ixekizumab

Placebo

Placebo Comparator group

Description:

Participants completed open label and met criteria for randomization to the double-blind Withdrawal Period. Double-Blind Withdrawal Period: Placebo given as one SC injection Q2W any time from randomization to week 104 (or, early termination or relapse)

Treatment:

Drug: Placebo

Drug: Ixekizumab

IXE80Q2W Non-randomized

Experimental group

Description:

Participants completed open label but did not meet criteria for randomization to the double-blind Withdrawal Period. Participants continued to receive 80 mg given as one SC injection every two weeks during the double-blind withdrawal period.

Treatment:

Drug: Ixekizumab