Clinical trial NCT02016482: A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Nail Psoriasis
Plaque Psoriasis
Keywords: Nail Psoriasis
Plaque Psoriasis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2013-12-20
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26
timeFrame: Week 26
measure: 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
timeFrame: Week 26
Secondary outcomes:
measure: Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26
timeFrame: Week 26
measure: Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26
timeFrame: Baseline, Week 26
measure: 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
timeFrame: Baseline, Week 26
measure: Percentage of Participants Achieving "Clear" or "Minimal" in Nail Bed Component of the PGA-F at Week 26
timeFrame: Week 26
measure: Percentage of Participants Achieving "Clear" or "Minimal" in Nail Matrix Component of the PGA-F At Week 26
timeFrame: Week 26
measure: Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26
timeFrame: Week 26
measure: Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26
timeFrame: Week 26
measure: Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26
timeFrame: Week 26
measure: Change From Baseline in Target Fingernail mNAPSI Score at Week 26
timeFrame: Baseline, Week 26
measure: Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Total Fingernail mNAPSI Score at Week 26
timeFrame: Baseline, Week 26
measure: Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26
timeFrame: Week 26
measure: Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26
timeFrame: Week 26
measure: Change From Baseline in Target Fingernail NAPSI Score at Week 26
timeFrame: Baseline, Week 26
measure: Percent Change From Baseline in Target Fingernail NAPSI Score at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Total Fingernail NAPSI Score at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26
timeFrame: Baseline, Week 26
measure: Percent Change From Baseline in PASI Score at Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26
timeFrame: Week 26
measure: Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) "Clear" or "Minimal" at Week 26
timeFrame: Week 26
measure: Percentage of Participants Achieving PGA-S of "Clear" at Week 26
timeFrame: Week 26
measure: Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26
timeFrame: Week 26
measure: Change From Baseline in Total Body Surface Area (BSA) at Week 26
timeFrame: Baseline, Week 26
measure: Percent Change From Baseline in Total BSA at Week 26
timeFrame: Baseline, Week 26
measure: Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26
timeFrame: Baseline, Week 26
measure: Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26
timeFrame: Baseline, Week 26
measure: Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26
timeFrame: Week 26
measure: Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Health State Assessment at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 26
timeFrame: Baseline, Week 26
measure: Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26
timeFrame: Baseline, Week 26
measure: Percentage of Participants With a New Diagnosis of Psoriatic Arthritis (PsA) During the Study
timeFrame: up to Week 26
measure: Change From Baseline in Nail Psoriasis Quality of Life (Nail PsQoL) Score at Week 26
timeFrame: Baseline, Week 26
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: David Williams, MD
role: STUDY_DIRECTOR
References: