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

NCT ID: NCT02016482

Last Updated: 2017-05-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-04-30

Brief Summary

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

Conditions

Nail Psoriasis; Plaque Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Adalimumab (ADA)

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.

Group Type: ACTIVE_COMPARATOR

Adalimumab

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: OTHER

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Adalimumab

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: OTHER

Interventions

Adalimumab

Intervention Type: BIOLOGICAL

Placebo

Intervention Type: OTHER

Other Intervention Names

ABT-D2E7; Humira

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Williams, MD

Role: STUDY_DIRECTOR

AbbVie

Other Identifiers

2013-003275-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-674

Identifier Type: -

Identifier Source: org_study_id