PsoriasisPhase 4NCT04535999
Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis (Phase IV)
A Phase 4 study testing Secukinumab Auto-Injector in people with Psoriasis, run by University of Pennsylvania at 1 site in United States.
Trial summary
This study will be an open label study of secukinumab for the treatment of nail psoriasis. Secukinumab is an FDA-approved treatment for psoriasis. We will examine time to response and different methods of defining nail disease response. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Secukinumab Auto-Injector
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2022to 30 May 2025
- Phase
- Phase 4
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active psoriatic nail disease defined as a Minimum 4 or more fingernails OR NAPSI>20
- Active skin psoriasis currently (no minimum PASI or BSA) or skin psoriasis in the past documented by a dermatologist
- Age 18-85
Who cannot join
- History of IL-17 inhibitor use (other therapies including TNF inhibitors or non- biologics DMARDS in the past are acceptable)
- Inflammatory bowel disease
- Metal implants or other concerns for use of MRI
- Active infection
- Patients may have a history of self-reported psoriatic arthritis but may not have active PsA at the time of screening.
- We will exclude patients with onychomyosis of the fingernails on clippings
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital at the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase IV Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis
This study will be an open label study of secukinumab for the treatment of nail psoriasis. Secukinumab is an FDA-approved treatment for psoriasis. We will examine time to response and different methods of defining nail disease response.
Read the detailed description
This study will be an open label study of secukinumab for the treatment of nail psoriasis. Secukinumab is an FDA-approved treatment for psoriasis. This is a single arm trial - all patients will receive the study drug. We will examine time to response and different methods of defining nail disease response.
- Conditions
- Psoriasis
- Being tested
- Secukinumab Auto-Injector
- Keywords
- Psoriasis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Secukinumab Auto-InjectorDrug
Also called Cosentyx
300 mg- Every 4 weeks after loading dose (Loading Dose-300 mg once weekly for 5 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Open Label | Experimental | Secukinumab Receives: Drug: Secukinumab Auto-Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in NAPSI
Nail Psoriasis Severity Index (NAPSI): NAPSI is the most comprehensive nail assessment used in clinical trials. The fingernail is divided into four quadrants. For each quadrant, 1 point is assigned for a nail matrix abnormality and 1 point for a nail bed abnormality allowing for a total of 8 points per nail. 0-80 total points possible with a higher score corresponding to a worse outcome.
Measured: 24 Weeks
Secondary outcomes (6)
Change in mNAPSI
modified Nail Psoriasis Severity Index (mNAPSI): A modified version of the primary outcome measure, the mNAPSI includes more features of nail disease. It has previously demonstrated greater correlation with the physician global assessment, assessing the nail as a whole rather than quadrants with improved reliability and responsiveness.
0-130 total points possible with a higher score corresponding to a worse outcome.
Measured: 24 Weeks
Change in Physician Global Assessment of Nail Disease
Physician Global Assessment of Nail Disease. Scale of 0-100 with higher score corresponding to a worse outcome (0=clear, 100=very severe).
Measured: 24 Weeks
Change in Patient Global Assessment of Nail Disease
Patient Global Assessment of Nail Disease. Scale of 0-10 with higher score corresponding to a worse outcome (0=excellent, 10=poor).
Measured: 24 Weeks
Change in PASI
Psoriasis Area Severity Index (PASI): Four assessments for each of four body areas (head, trunk, upper extremities, and lower extremities) are provided. The assessments are erythema, induration, and scale (each assessed as 0-4 using a standardized scale), and the number of palms/percentage of each area is categorized (0 = 0%, 1 = less than 10%, 2 = 10%-29%, 3 = 30%-40%, 4 = 50%-69%, Scale of 0 to 72 with a higher score corresponding to a worse outcome.
Measured: 24 Weeks
Change in DLQI
Dermatology Life Quality Index (DLQI):
There are a total of 10 questions and each question is scored on a four-point Likert scale:
Very much = 3 A lot = 2 A little = 1 Not at all = 0 Not relevant = 0 Question unanswered = 0
The DLQI is calculated by adding the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired. A score higher than 10 indicates that the patient's life is being severely affected by their skin disease.
Measured: 24 Weeks
Change in NAPPA
Nail Assessment in Psoriasis and Psoriatic Arthritis (NAPPA): Patient-reported outcome designed to emphasize quality of life, patient-related needs, and treatment benefit. The NAPPA captures domains such as pain, function, cosmetic, and psychosocial burden.
The NAPPA QoL contains 20 questions, each scored on a five-point Likert scale:
0 = not at all
- = somewhat
- = moderately
- = quite a bit
5 = very
The score is calculated by adding the score of each question, resulting in a maximum of 100 and a minimum of 0. Higher score indicates greater impact of disease.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start7 Feb 2022
- Primary completion30 May 2025
- Study completion30 May 2025
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 PsoriasisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention-Secukinumab
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis
- Responsible party
- Sponsor
- Investigators
- Alexis Ogdie-Beatty, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535999
- Sponsor's protocol ID
- 834149
- Status last verified
- Oct 2026
- First submitted
- 27 Aug 2020
- Last updated
- 30 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Open Label Study of the Effects of Secukinumab on Nail Psoriasis and Non-Invasive Measures of Enthesitis
- ClinicalTrials.gov ID
- NCT04535999
- Acronym / sponsor ID
- 834149
- Conditions
- Psoriasis
- Keywords
- Psoriasis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Novartis
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 2 Sep 2020 (actual)
- Results
- Posted 30 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be an open label study of secukinumab for the treatment of nail psoriasis. Secukinumab is an FDA-approved treatment for psoriasis. We will examine time to response and different methods of defining nail disease response.
Detailed description
This study will be an open label study of secukinumab for the treatment of nail psoriasis. Secukinumab is an FDA-approved treatment for psoriasis. This is a single arm trial - all patients will receive the study drug. We will examine time to response and different methods of defining nail disease response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention-Secukinumab
| Arm | Type | Receives |
|---|---|---|
| Open Label | Experimental | Drug: Secukinumab Auto-InjectorSecukinumab |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active psoriatic nail disease defined as a Minimum 4 or more fingernails OR NAPSI>20
- Active skin psoriasis currently (no minimum PASI or BSA) or skin psoriasis in the past documented by a dermatologist
- Age 18-85
Key exclusion criteria (6 listed)
- History of IL-17 inhibitor use (other therapies including TNF inhibitors or non- biologics DMARDS in the past are acceptable)
- Inflammatory bowel disease
- Metal implants or other concerns for use of MRI
- Active infection
- Patients may have a history of self-reported psoriatic arthritis but may not have active PsA at the time of screening.
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 |
|---|---|---|
| Secukinumab Auto-InjectorAlso: Cosentyx300 mg- Every 4 weeks after loading dose (Loading Dose-300 mg once weekly for 5 weeks) | Drug | Open Label |
Primary outcome
Change in NAPSI
Time frame: 24 Weeks
Nail Psoriasis Severity Index (NAPSI): NAPSI is the most comprehensive nail assessment used in clinical trials. The fingernail is divided into four quadrants. For each quadrant, 1 point is assigned for a nail matrix abnormality and 1 point for a nail bed abnormality allowing for a total of 8 points per nail. 0-80 total points possible with a higher score corresponding to a worse outcome.
6 secondary outcomes
Change in mNAPSI
Time frame: 24 Weeks
Change in Physician Global Assessment of Nail Disease
Time frame: 24 Weeks
Change in Patient Global Assessment of Nail Disease
Time frame: 24 Weeks
Change in PASI
Time frame: 24 Weeks
Change in DLQI
Time frame: 24 Weeks
Change in NAPPA
Time frame: 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Active, not recruitingPhase 2
Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis
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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.
Alexis Ogdie-Beatty, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Secukinumab Auto-Injector in people with Psoriasis, run by University of Pennsylvania at 1 site in United States.
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 3 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 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 30 Oct 2026). 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?
Change in NAPSI (time frame: 24 Weeks). 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 Oct 2026.