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

NCT02016482 | Completed Phase 3 Results

• 2 other identifiers: M13-6742013-003275-36
• Study Type: interventional
• Target: 217
• Locations: 0 countries
• Sites: N/A

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

Keywords

Nail Psoriasis; Plaque Psoriasis

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26

  Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. Investigators assessed each nail abnormality for each of a participant's nails by grading 3 features or groups of features (pitting, onycholysis and oil-drop dyschromia, and crumbling) and noting the presence or absence of 4 features (leukonychia, splinter hemorrhages, hyperkeratosis, and red spots in the lunula). The range of possible scores was 0 to 130, with a score of 0 indicating absence of nail psoriasis and a score of 130 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement. The mNAPSI 75 response is defined as at least 75% reduction from baseline in mNAPSI.

  Week 26

• For United States (US) Regulatory Purposes: Percentage of Participants With a Physician's Global Assessment of Fingernails (PGA-F) of "Clear" or "Minimal" at Week 26

  The PGA-F is a 5-point scale used to assess fingernails separately for nail bed signs and nail matrix signs of disease. A global score of between 0 indicating clear, and 4 indicating severe, was separately assigned for nail bed involvement and nail matrix involvement. A participant's overall global score was the worse of the nail bed and nail matrix score. Data presents the percentage of participants with a PGA-F overall global score that met the definition of "clear" (0) or "minimal" (1) with at least a 2-grade improvement relative to Baseline at Week 26.

  Week 26

Secondary Outcomes (39)

• Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26

  Baseline, Week 26

• Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26

  Week 26

• Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26

  Baseline, Week 26

• Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26

  Baseline, Week 26

• Percentage of Participants With at Least 50% Improvement in the Scalp Component of the Brigham Scalp Nail Inverse Palmo-Plantar Psoriasis Index (B-SNIPI) at Week 26

  Baseline, Week 26

Study Arms (2)

Adalimumab (ADA)

ACTIVE COMPARATOR

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.

Biological: Adalimumab; Other: Placebo

Placebo

PLACEBO COMPARATOR

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.

Biological: Adalimumab; Other: Placebo

Interventions

Adalimumab BIOLOGICAL

Also known as: ABT-D2E7, Humira

Adalimumab (ADA); Placebo

Placebo OTHER

Adalimumab (ADA); Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

Due to study design, a high percentage of participants randomized to the placebo arm early escaped from Period A and thus participated for a shorter duration than did participants in the active treatment arm.

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• David Williams, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: December 20, 2013
• Study Start: January 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: April 1, 2016
• Last Updated: May 30, 2017
• Results First Posted: February 13, 2017

Record last verified: 2017-04