A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis

A Phase 3, Multicenter, Double-Blind, Randomized, Parallel-Arm, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Adalimumab for Treatment of Nail Psoriasis in Patients With Chronic Plaque Psoriasis

This study is being conducted to assess the safety and efficacy of adalimumab in participants with nail psoriasis.

Inclusion Criteria:

• Subject must have body surface area (BSA) ≥ 10% and a target fingernail Modified Nail Psoriasis Severity Index (mNAPSI) ≥ 8 at Week 0, OR BSA ≥ 5%, a target fingernail mNAPSI ≥ 8 and a total mNAPSI score of ≥ 20 at Week 0.
• Subject must have a Nail Psoriasis Physical Functioning Severity score of > 3, OR a Nail Psoriasis Pain Numeric Rating Scale (NRS) score of >3.
• Subjects must have a Physician's Global Assessment (PGA) of Fingernail Psoriasis and a PGA of Skin Psoriasis of at least moderate.
• Subject must have discontinued use of all systemic therapies for the treatment of psoriasis, or systemic therapies known to improve psoriasis for at least 4 weeks prior to Week 0, ustekinumab must have been discontinued at least 12 weeks prior to Week 0.
• Target fingernail must have mNAPSI score of ≥ 8.
• Adult subjects with clinical diagnosis of chronic plaque psoriasis (with disease duration of at least 6 months).

Exclusion Criteria:

• Prior adalimumab therapy.
• Diagnosis of other active skin diseases or skin infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis.
• Recent infection requiring treatment.
• Significant medical events or conditions that may put patients at risk for participation, including recent history of drug or alcohol abuse.
• Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
• History of cancer, except successfully treated skin cancer.