Phase 3
N=217
A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis
Nail Psoriasis · Plaque Psoriasis
Bottom Line
View on ClinicalTrials.gov: NCT02016482 ↗Enrolled (actual)
217
Serious AEs
4.7%
Results posted
Feb 2017
Primary outcome: Primary: Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26 — 3.4; 46.6 percentage of participants — p=< 0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Adalimumab (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AbbVie
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26 |
3.4; 46.6 | < 0.001 sig |
| PRIMARY 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 |
6.9; 48.9 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26 |
-11.5; -56.2 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26 |
0.0; 6.6 | 0.008 sig |
| SECONDARY Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26 |
-1.1; -3.7 | < 0.001 sig |
| SECONDARY Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26 |
-0.8; -3.7 | < 0.001 sig |
| SECONDARY 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 |
0.4; 58.3 | 0.002 sig |
| SECONDARY Percentage of Participants Achieving "Clear" or "Minimal" in Nail Bed Component of the PGA-F at Week 26 |
8.2; 51.4 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving "Clear" or "Minimal" in Nail Matrix Component of the PGA-F At Week 26 |
8.5; 53.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26 |
1.3; 19.9 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26 |
7.3; 43.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26 |
0.2; 13.4 | <0.001 sig |
| SECONDARY Change From Baseline in Target Fingernail mNAPSI Score at Week 26 |
-2.1; -5.7 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26 |
-23.0; -61.9 | < 0.001 sig |
| SECONDARY Change From Baseline in Total Fingernail mNAPSI Score at Week 26 |
-7.5; -36.1 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26 |
-13.2; -63.3 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26 |
0.0; 7.5 | 0.004 sig |
| SECONDARY Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26 |
2.4; 20.8 | < 0.001 sig |
| SECONDARY Change From Baseline in Target Fingernail NAPSI Score at Week 26 |
-1.1; -3.6 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Target Fingernail NAPSI Score at Week 26 |
-14.4; -54.6 | < 0.001 sig |
| SECONDARY Change From Baseline in Total Fingernail NAPSI Score at Week 26 |
-6.7; -26.2 | < 0.001 sig |
| SECONDARY Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26 |
-0.9; -9.0 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in PASI Score at Week 26 |
2.4; -68.7 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26 |
13.8; 64.8; 25.3; 77.8; 7.1; 48.0 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) "Clear" or "Minimal" at Week 26 |
11.2; 63.4 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving PGA-S of "Clear" at Week 26 |
4.0; 28.8 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26 |
0.5; 90.8 | < 0.001 sig |
| SECONDARY Change From Baseline in Total Body Surface Area (BSA) at Week 26 |
0.4; -10.7 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Total BSA at Week 26 |
12.8; -67.8 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26 |
-18.0; -68.9 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26 |
-9.9; -67.6 | < 0.001 sig |
| SECONDARY Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26 |
-0.4; -1.3 | < 0.001 sig |
| SECONDARY Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26 |
-11.7; -39.5 | < 0.001 sig |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26 |
-1.9; -8.0 | < 0.001 sig |
| SECONDARY Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26 |
2.5; 18.2; 3.7; 30.8 | < 0.001 sig |
| SECONDARY Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26 |
-1.0; -0.3; -3.4; -20.7; -6.2; -21.3 | 0.416 |
| SECONDARY Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Health State Assessment at Week 26 |
0.0; 0.1 | < 0.001 sig |
| SECONDARY Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 26 |
-0.1; 5.5 | 0.012 sig |
| SECONDARY Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26 |
-0.1; -1.1; 0.0; -1.4 | 0.025 sig |
| SECONDARY Percentage of Participants With a New Diagnosis of Psoriatic Arthritis (PsA) During the Study |
0; 2 | 0.164 |
| SECONDARY Change From Baseline in Nail Psoriasis Quality of Life (Nail PsQoL) Score at Week 26 |
-0.6; -3.3 | < 0.001 sig |
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.
Data sourced from ClinicalTrials.gov (NCT02016482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.