Nail PsoriasisEarly Phase 1NCT05124080
An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Deucravacitinib for the Treatment of Nail Psoriasis
A Early Phase 1 study testing Deucravacitinib in people with Nail Psoriasis, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
. An open label proof of concept study will be conducted to assess the efficacy and safety of deucravactinib for treatment of nail psoriasis. Twenty adult patients with nail psorasis and skin disease qualifying for a systemic agent per investigator will be treated with deucravacitinib 6 mg daily. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Nail Psoriasis
- What is being tested?
- Deucravacitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Patients 18 and older
- Give written informed consent prior to any study procedures being conducted, and candidates will authorize the release and use of protected health information (PHI)
- Be willing and consent to having photos taken of their fingernails
- Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
- Diagnosis of chronic plaque psoriasis that has been present for at least 6 months prior to baseline
- Plaque psoriasis qualifying for a systemic agent per investigator.
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- Nail psoriasis in at least one finger nail with a mNAPSI of 8 or greater or a total modified Nail Psoriasis Severity Index of 20 or greater
- A Nail Pain NRS score of 3 or higher. The Nail Pain NRS will assess the severity of pain linked to the nail disease.
- Must have discontinued all systemic therapies for the treatment of psoriasis or psoriatic arthritis at least 4 weeks or 5 half-lives, and biologics for at least 2 months or 5 half-lives (whichever is longer) prior to baseline visit
- Must have discontinued all topical therapies for the treatment of psoriasis at least 2 weeks prior to baseline visit
- Subjects must have discontinued UV therapy at least 2 weeks prior to baseline and PUVA at least 4 weeks prior to baseline.
- Subjects must be in good general health without significant uncontrolled comorbidities, other than psoriasis, as determined by the investigator based on exam findings, medical history, and clinical laboratories. Patients with stable mild renal insufficiency are eligible for enrolling in this trial.
- Females of childbearing potential must use an approved birth control method while receiving treatment and for 28 days following the last dose of deucravacitinib, and there must be a documented negative pregnancy tests prior to initiating treatment. Approved birth control methods include hormonal contraception (oral, injection, implant, transdermal patch, vaginal ring), intrauterine device, tubal ligation (tying your tubes), partners vasectomy, or male or female condoms that are not made of natural materials PLUS a diaphragm with spermicide, cervical cap with spermicide, or a contraceptive sponge with spermicide. Females not of child bearing potential are defined as being at least 1 year postmenopausal or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy).
- Male subjects, including those who have had a vasectomy, must use condoms not made of natural materials for the duration of the trial and for at least 28 days after the last dose of deucravacitinib if conception is possible.
Who cannot join
- Other than disease under study, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
- Pregnant or breast feeding.
- Active substance abuse or a history of substance abuse within 6 months prior to Screening.
- Malignancy or history of malignancy, except for:
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- treated [ie, cured] basal cell or squamous cell in situ skin carcinomas;
- treated [ie, cured] cervical intraepithelial neoplasia (CIN) or carcinoma in situ of cervix with no evidence of recurrence within the previous 5 years.
- Use of any investigational drug within 4 weeks prior to randomization, or 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).
- Prior treatment with deucravacitinib.
- Unable to comply with the protocol (as defined by the Investigator; i.e. drug or alcohol abuse or history of noncompliance).
- Concomitant therapy with medications that are strong cytochrome P450 inducers, including rifampin, phenobarbital, carbamazepine, or phenytoin.
- Any other dermatologic conditions that prohibit or confound the ability of the investigator to interpret skin and/or nail exam findings.
- Patients who will be unable to avoid the use of systemic steroids, excluding intranasal or inhaled steroids that will be permitted, for the duration of the trial.
- Any known hypersensitivity to deucravacitinib.
- Prisoners or subjects who are involuntarily incarcerated
- Subjects who are compulsorily detained for treatment of either psychiatric or physical illness
- Inability to comply with restrictions and prohibited activities listed in study protocol
- Site personnel or their immediate family
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham - Department of Dermatology
Birmingham, Alabama, 35233
About this study
. An open label proof of concept study will be conducted to assess the efficacy and safety of deucravactinib for treatment of nail psoriasis. Twenty adult patients with nail psorasis and skin disease qualifying for a systemic agent per investigator will be treated with deucravacitinib 6 mg daily. Subjects will be assessed for a total of 48 weeks. Psoriasis assessments such as the modified Nail Psoriasis Severity Index will be conducted. Photos will be used to document nail involvement. Descriptive statistical analysis will be conducted at the conclusion of the study.
- Conditions
- Nail Psoriasis
- Being tested
- Deucravacitinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DeucravacitinibDrug
All participants will receive 6 mg of Deucravacitinib daily.
| Study group | Role | What they receive |
|---|---|---|
| Deucravacitinib 6 mg Daily | Experimental | All participants will receive 6 mg of deucravacitinib daily. Receives: Drug: Deucravacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the modified Nail Psoriasis Severity Index (mNAPSI) compared to baseline
Mean percent change of mNAPSI
Measured: baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2021
- Study start1 Mar 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nail PsoriasisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boni Elewski, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124080
- Sponsor's protocol ID
- IRB-300008245
- Other IDs
- 2028180
- Status last verified
- Dec 2025
- First submitted
- 5 Nov 2021
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator Initiated Open Label Study Evaluating the Efficacy and Tolerability of Oral Deucravacitinib for the Treatment of Nail Psoriasis
- ClinicalTrials.gov ID
- NCT05124080
- Acronym / sponsor ID
- IRB-300008245
- Conditions
- Nail Psoriasis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 17 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
. An open label proof of concept study will be conducted to assess the efficacy and safety of deucravactinib for treatment of nail psoriasis. Twenty adult patients with nail psorasis and skin disease qualifying for a systemic agent per investigator will be treated with deucravacitinib 6 mg daily. Subjects will be assessed for a total of 48 weeks. Psoriasis assessments such as the modified Nail Psoriasis Severity Index will be conducted. Photos will be used to document nail involvement. Descriptive statistical analysis will be conducted at the conclusion of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Deucravacitinib 6 mg Daily | Experimental | Drug: DeucravacitinibAll participants will receive 6 mg of deucravacitinib daily. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Patients 18 and older
- Give written informed consent prior to any study procedures being conducted, and candidates will authorize the release and use of protected health information (PHI)
- Be willing and consent to having photos taken of their fingernails
- Must be in general good health (except for disease under study) as judged by the Investigator, based on medical history, physical examination, clinical laboratories, and urinalysis. (NOTE: The definition of good health means a subject does not have uncontrolled significant co-morbid conditions).
- Diagnosis of chronic plaque psoriasis that has been present for at least 6 months prior to baseline
Key exclusion criteria (19 listed)
- Other than disease under study, any clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is currently uncontrolled.
- Any condition, including the presence of laboratory abnormalities, which would place the subject at unacceptable risk if he/she were to participate in the study.
- Prior history of suicide attempt at any time in the subject's life time prior to screening or randomization, or major psychiatric illness requiring hospitalization within the last 3 years.
- Pregnant or breast feeding.
- Active substance abuse or a history of substance abuse within 6 months prior to 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 |
|---|---|---|
| DeucravacitinibAll participants will receive 6 mg of Deucravacitinib daily. | Drug | Deucravacitinib 6 mg Daily |
Primary outcome
Change in the modified Nail Psoriasis Severity Index (mNAPSI) compared to baseline
Time frame: baseline to week 24
Mean percent change of mNAPSI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Deucravacitinib in people with Nail Psoriasis, run by University of Alabama at Birmingham 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 14 inclusion and 19 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 8 Jan 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the modified Nail Psoriasis Severity Index (mNAPSI) compared to baseline (time frame: baseline to week 24). 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 8 Jan 2026.