A Study of Ixekizumab (LY2439821) Versus Adalimumab in Participants With Psoriatic Arthritis (SPIRIT-H2H)

Lilly

Status and phase: Completed; Phase 4

Conditions: Psoriatic Arthritis

Treatments: Drug: Adalimumab; Drug: Ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03151551

2016-004585-25 (EudraCT Number)

16687

I1F-MC-RHCF (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate the effectiveness and safety of ixekizumab versus adalimumab in participants with psoriatic arthritis (PsA) who are biologic disease-modifying anti-rheumatic drugs (DMARD) naive.

Enrollment: 566 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of established diagnosis of active psoriatic arthritis for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
• Active PsA defined as the presence of at least 3 (out of 68) tender and at least 3 (out of 66) swollen joints
• Presence of active plaque psoriasis with a BSA ≥3%
• 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 had an inadequate response when treated with 1 or more conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)

Exclusion criteria

• Current or prior use of biologic agents for treatment of Ps or PsA
• 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
• Active Crohn's disease or active ulcerative colitis
• Active vasculitis or uveitis
• Diagnosis of or history of malignant disease <5 years prior to randomization
• Women who are breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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566 participants in 2 patient groups

Ixekizumab

Experimental group

Description:

160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline for all participants. 80 mg ixekizumab given once every 2 weeks (Q2W) SC from week 2 to week 12 and once every 4 weeks (Q4W) thereafter for participants with moderate-to-severe plaque Ps. 80 mg ixekizumab given SC Q4W starting week 4 for participants not meeting criteria for moderate-to-severe plaque Ps.

Treatment:

Drug: Ixekizumab

Adalimumab

Active Comparator group

Description:

80 mg adalimumab given SC at baseline followed by 40 mg Q2W given SC starting week 1 for participants with moderate-to-severe plaque Ps. 40 mg adalimumab given Q2W SC at baseline followed by 40 mg Q2W starting at Week 2 given SC for participants not meeting criteria for moderate-to-severe plaque Ps.

Treatment:

Drug: Adalimumab