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

AbbVie

Status and phase: Completed; Phase 3

Conditions: Plaque Psoriasis; Nail Psoriasis

Treatments: Other: Placebo; Biological: Adalimumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02016482

M13-674

2013-003275-36 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 217 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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217 participants in 2 patient groups, including a placebo group

Adalimumab (ADA)

Active Comparator group

Description:

Period A: ADA 40 mg subcutaneous every other week (sc eow) for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Treatment:

Other: Placebo

Biological: Adalimumab

Placebo

Placebo Comparator group

Description:

Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.

Treatment:

Other: Placebo

Biological: Adalimumab