Nail PsoriasisPhase 3NCT02016482
A Study to Evaluate the Safety and Efficacy of Adalimumab in Subjects With Chronic Plaque Psoriasis and Nail Psoriasis
A Phase 3 study testing Adalimumab in people with Nail Psoriasis and Plaque Psoriasis, run by AbbVie.
Trial summary
This study is being conducted to assess the safety and efficacy of adalimumab in participants with nail psoriasis. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Nail Psoriasis, Plaque Psoriasis
- What is being tested?
- Adalimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 217 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Apr 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
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
This study is being conducted to assess the safety and efficacy of adalimumab in participants with nail psoriasis.
- Conditions
- Nail Psoriasis, Plaque Psoriasis
- Being tested
- Adalimumab, Placebo
- Keywords
- Nail Psoriasis, Plaque Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabBiological
Also called ABT-D2E7, Humira
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: Adalimumab; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Week 26
Secondary outcomes (39)
Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26
Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
Measured: Baseline, Week 26
Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26
Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. 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.
Measured: Week 26
Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26
An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.
Measured: Baseline, Week 26
Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26
Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.
Measured: 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
The range of possible scores was 0 to 20 for scalp psoriasis, with a score of 0 indicating absence of psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the scalp component of the B-SNIPI among participants with Baseline scalp score of ≥ 6.
Measured: Baseline, Week 26
Percentage of Participants Achieving "Clear" or "Minimal" in Nail Bed Component of the PGA-F 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 nail bed component of the PGA-F that met definition of "clear" (0) or "minimal" (1) among those with a Baseline nail bed component of "moderate" or "worse."
Measured: Week 26
Percentage of Participants Achieving "Clear" or "Minimal" in Nail Matrix Component of the PGA-F 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 nail matrix component of the PGA-F that met definition of "clear" (0) or "minimal" (1) among those with a Baseline nail matrix component of "moderate" or "worse."
Measured: Week 26
Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26
The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Measured: Week 26
Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26
The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Measured: Week 26
Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26
Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. 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.
Measured: Week 26
Change From Baseline in Target Fingernail mNAPSI Score at Week 26
The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Measured: Baseline, Week 26
Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26
The target fingernail was assessed for psoriasis with mNAPSI. The range of possible scores was 0 to 13, with a score of 0 indicating absence of nail psoriasis and a score of 13 indicating the most severe nail psoriasis. A decrease in mNAPSI score indicates improvement.
Measured: Baseline, Week 26
Change From Baseline in Total Fingernail mNAPSI Score at Week 26
Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. 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.
Measured: Baseline, Week 26
Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26
Each fingernail was assessed for psoriasis with mNAPSI, and the scores of all 10 fingernails were combined. 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.
Measured: Baseline, Week 26
Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26
Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
Measured: Week 26
Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26
The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
Measured: Week 26
Change From Baseline in Target Fingernail NAPSI Score at Week 26
The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
Measured: Baseline, Week 26
Percent Change From Baseline in Target Fingernail NAPSI Score at Week 26
The target fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI. The range of possible scores was 0 to 8, with a score of 0 indicating absence of nail psoriasis and 8 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
Measured: Baseline, Week 26
Change From Baseline in Total Fingernail NAPSI Score at Week 26
Each fingernail was assessed for nail matrix psoriasis and nail bed psoriasis with NAPSI and the scores of all 10 fingernails were combined. The range of possible scores was 0 to 80, with a score of 0 indicating absence of nail psoriasis and 80 indicating most severe nail psoriasis. A decrease in NAPSI score indicates improvement.
Measured: Baseline, Week 26
Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. A decrease in PASI score indicates improvement.
Measured: Baseline, Week 26
Percent Change From Baseline in PASI Score at Week 26
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. A decrease in PASI score indicates improvement.
Measured: Baseline, Week 26
Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26
PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 to 72, with 0 indicating no psoriasis and 72 indicating very severe psoriasis. PASI-75, 50, 90, and 100 responses are the percentage of participants with a Baseline PASI score ≥ 5 who achieved at least a 75%, 50%, 90%, or 100% reduction (improvement), respectively, from Baseline in PASI score at Week 26. A 100% reduction was considered complete clearance of psoriasis. Data presents the percentage of participants achieving PASI 75/50/90/100 responses at Week 26 among participants with a Baseline PASI score ≥ 5.
Measured: Week 26
Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) "Clear" or "Minimal" at Week 26
The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of "clear" (0) or "minimal" (1) with at least a 2-grade improvement relative to Baseline at Week 26.
Measured: Week 26
Percentage of Participants Achieving PGA-S of "Clear" at Week 26
The PGA-S is a 6-point scale used to measure the severity of skin disease at the time of the qualified investigator's evaluation of the participant. The degree of overall lesion severity was assessed, with 0 indicating cleared and 5 indicating severe. A decrease in PGA-S score indicates improvement. Data present the percentage of participants achieving a PGA-S of "clear" (0) with at least a 2-grade improvement relative to Baseline at Week 26.
Measured: Week 26
Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26
The range of possible B-SNIPI scores was 0 to 20 for inverse psoriasis, with a score of 0 indicating absence of psoriasis and a score of 20 indicating most severe psoriasis. A decrease in B-SNIPI score indicates improvement. Data presents the percentage of participants achieving 50% improvement in the inverse component of the B-SNIPI among participants with a Baseline inverse psoriasis score of ≥ 6.
Measured: Week 26
Change From Baseline in Total Body Surface Area (BSA) at Week 26
BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.
Measured: Baseline, Week 26
Percent Change From Baseline in Total BSA at Week 26
BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.
Measured: Baseline, Week 26
Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26
An NRS was used to capture a participant's self-reporting of her/his worst fingernail pain and average fingernail pain due to fingernail psoriasis. The participant rated the severity of fingernail pain over the past 7 days on a scale from 0 indicating no pain, to 10 indicating severe pain. A negative change from Baseline indicates improvement.
Measured: Baseline, Week 26
Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26
Participants were asked to rate the impact of their fingernail psoriasis on their ability to perform physical tasks (eg, typing, housework, buttoning a shirt or blouse, picking up coins from a table, tying shoes, yard work, etc.) over the past 7 days on a scale of 0 indicating no impact on ability to perform physical tasks, to 10 indicating severe impact on ability to perform physical tasks. A negative change from Baseline indicates improvement.
Measured: Baseline, Week 26
Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26
Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.
Measured: Baseline, Week 26
Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26
Participants rated specific impacts of fingernail psoriasis on various aspects of their QoL over the past 7 days on a 5-point scale, with 0 indicating not at all, and 4 indicating very impactful. A participant's overall global score was the mean of all items and could range from 0 to 4, with 0 indicating no impact and 4 indicating most impact. A decrease in NAPPA QoL score indicates improvement.
Measured: Baseline, Week 26
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26
Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement.
Measured: Baseline, Week 26
Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26
Participants assessed symptoms and impacts of dermatologic diseases on their QoL over the past 7 days, with 0 indicating not at all, and 3 indicating very much. The range of possible DLQI scores was 0 to 30, with a score of 0 indicating no effect at all on a participant's life and a score of 30 indicating extremely large effect on participant's life. A decrease in DLQI score indicates improvement. Data presents the percentage of participants with a score of 0 (no effect) or 1 (little effect) at Week 26.
Measured: Week 26
Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26
The WPAI: NPSO assessed impact of fingernail psoriasis on work productivity and non-work activity limitation. Participants were asked during the past 7 days, how many hours did you miss from work because of problems associated with your fingernail psoriasis (absenteeism), during the past seven days, how many hours did you miss from work because of any other reason, such as vacation, holidays, time off to participate in this study (presenteeism), how much did your fingernail psoriasis affect your productivity while you were working (overall work impairment), and much did your fingernail psoriasis affect your ability to do your regular daily activities, other than work at a job (activity impairment). Answers were rated on an 11-point scale, with 0 indicating "fingernail psoriasis had no effect on this" and 10 indicating "fingernail psoriasis completely prevented me from this." A decrease in the WPAI:NPSO score indicates improvement.
Measured: Baseline, Week 26
Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Health State Assessment at Week 26
The EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self -care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement.
Measured: Baseline, Week 26
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 26
The EQ-5D VAS records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement.
Measured: Baseline, Week 26
Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26
Participants rated their anxiety and depression over the past 7 days at Week 26. The range of possible scores was 0 to 21, with a score of 0 indicating absence of anxiety and depression and 21 indicating the most severe anxiety and depression. A decrease in HADS score indicates improvement.
Measured: Baseline, Week 26
Percentage of Participants With a New Diagnosis of Psoriatic Arthritis (PsA) During the Study
The percentage of participants with a new diagnosis of PsA (ie, with an adverse event of PsA) during the study, among participants without PsA at Baseline.
Measured: up to Week 26
Change From Baseline in Nail Psoriasis Quality of Life (Nail PsQoL) Score at Week 26
Participants were asked how their fingernail psoriasis impacted their overall quality of life over the past 7 days on an 11-point scale, with 0 indicating no impact, and 10 indicating severe impact. A negative change from Baseline indicates improvement.
Measured: Baseline, Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionOct 2015
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nail PsoriasisStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Williams, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016482
- Sponsor's protocol ID
- M13-674
- Other IDs
- 2013-003275-36
- Status last verified
- Apr 2017
- First submitted
- 16 Dec 2013
- Last updated
- 30 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02016482
- Acronym / sponsor ID
- M13-674
- Conditions
- Nail Psoriasis, Plaque Psoriasis
- Keywords
- Nail Psoriasis, Plaque Psoriasis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Posted 13 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to assess the safety and efficacy of adalimumab in participants with nail psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adalimumab (ADA) | Active comparator | Biological: Adalimumab, Other: PlaceboPeriod 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. |
| Placebo | Placebo comparator | Biological: Adalimumab, Other: PlaceboPeriod 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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabAlso: ABT-D2E7, Humira | Biological | Adalimumab (ADA), Placebo |
| Placebo | Other | Adalimumab (ADA), Placebo |
Primary outcome
Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26
Time frame: 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.
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
Time frame: 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.
39 secondary outcomes
Percent Change From Baseline in Total Fingernail Nail Psoriasis Severity Index (NAPSI) Score at Week 26
Time frame: Baseline, Week 26
Percentage of Participants Achieving Total Fingernail mNAPSI Score of 0 at Week 26
Time frame: Week 26
Percent Change From Baseline in Nail Psoriasis Pain Numeric Rating Scale (NRS) at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26
Time frame: 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
Time frame: Baseline, Week 26
Percentage of Participants Achieving "Clear" or "Minimal" in Nail Bed Component of the PGA-F at Week 26
Time frame: Week 26
Percentage of Participants Achieving "Clear" or "Minimal" in Nail Matrix Component of the PGA-F At Week 26
Time frame: Week 26
Percentage of Participants Achieving Target Fingernail mNAPSI Score of 0 at Week 26
Time frame: Week 26
Percentage of Participants Achieving Target Fingernail mNAPSI Score of ≤ 2 at Week 26
Time frame: Week 26
Percentage of Participants Achieving Total Fingernail mNAPSI Score of ≤ 2 at Week 26
Time frame: Week 26
Change From Baseline in Target Fingernail mNAPSI Score at Week 26
Time frame: Baseline, Week 26
Percent Change From Baseline in Target Fingernail mNAPSI Score at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Total Fingernail mNAPSI Score at Week 26
Time frame: Baseline, Week 26
Percent Change From Baseline in Total Fingernail mNAPSI Score at Week 26
Time frame: Baseline, Week 26
Percentage of Participants Achieving Total Fingernail NAPSI Score of 0 at Week 26
Time frame: Week 26
Percentage of Participants Achieving Target Fingernail NAPSI Score of 0 at Week 26
Time frame: Week 26
Change From Baseline in Target Fingernail NAPSI Score at Week 26
Time frame: Baseline, Week 26
Percent Change From Baseline in Target Fingernail NAPSI Score at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Total Fingernail NAPSI Score at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Psoriasis Area Severity Index (PASI) Score at Week 26
Time frame: Baseline, Week 26
Percent Change From Baseline in PASI Score at Week 26
Time frame: Baseline, Week 26
Percentage of Participants Achieving PASI 75/50/90/100 Responses at Week 26
Time frame: Week 26
Percentage of Participants Achieving Physician's Global Assessment of Skin Psoriasis (PGA-S) "Clear" or "Minimal" at Week 26
Time frame: Week 26
Percentage of Participants Achieving PGA-S of "Clear" at Week 26
Time frame: Week 26
Percentage of Participants Achieving 50% Improvement in the Inverse Psoriasis Component of the B-SNIPI at Week 26
Time frame: Week 26
Change From Baseline in Total Body Surface Area (BSA) at Week 26
Time frame: Baseline, Week 26
Percent Change From Baseline in Total BSA at Week 26
Time frame: Baseline, Week 26
Percent Change From Baseline in Nail Psoriasis Pain NRS at Week 26
Time frame: Baseline, Week 26
Percent Change From Baseline in Nail Psoriasis Physical Functioning Severity Score at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Nail Assessment in Psoriasis and Psoriatic Arthritis Quality of Life (NAPPA QoL) at Week 26
Time frame: Baseline, Week 26
Percent Change From Baseline in Nail Assessment in NAPPA QoL at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 26
Time frame: Baseline, Week 26
Percentage of Participants Achieving DLQI of 0 and 0/1 at Week 26
Time frame: Week 26
Change From Baseline in Work Productivity and Activity Impairment Nail Psoriasis (WPAI:NPSO) at Week 26
Time frame: Baseline, Week 26
Change From Baseline in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) Health State Assessment at Week 26
Time frame: Baseline, Week 26
Change From Baseline in EQ-5D Visual Analogue Scale (VAS) at Week 26
Time frame: Baseline, Week 26
Change From Baseline in Hospital Anxiety Depression Scale (HADS) at Week 26
Time frame: Baseline, Week 26
Percentage of Participants With a New Diagnosis of Psoriatic Arthritis (PsA) During the Study
Time frame: up to Week 26
Change From Baseline in Nail Psoriasis Quality of Life (Nail PsQoL) Score at Week 26
Time frame: Baseline, Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Williams, MD study director
AbbVie
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalimumab in people with Nail Psoriasis and Plaque Psoriasis, run by AbbVie.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving a Total Fingernail Modified Nail Psoriasis Severity Index (mNAPSI) 75 Response at Week 26 (time frame: Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.