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

Lilly

Status and phase: Completed; Phase 3

Conditions: Psoriasis, Arthritic

Treatments: Drug: Ixekizumab; Drug: Adalimumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01695239

13731

I1F-MC-RHAP (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 417 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 personal 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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417 participants in 4 patient groups, including a placebo group

Ixekizumab Q2W

Experimental group

Description:

Administered by 80 milligram (mg) subcutaneous (SC) injection every 2 weeks (Q2W).

Treatment:

Drug: Ixekizumab

Ixekizumab Q4W

Experimental group

Description:

Administered by 80 mg SC injection every 4 weeks (Q4W).

Treatment:

Drug: Ixekizumab

Placebo

Placebo Comparator group

Description:

Placebo for ixekizumab and placebo for adalimumab administered by SC injection.

Treatment:

Drug: Placebo

Adalimumab Q2W

Active Comparator group

Description:

Administered by 40 mg SC injection Q2W.

Treatment:

Drug: Adalimumab