PsoriasisNCT05570955
Deucravacitinib Adherence Study
A study testing Text reminder in people with Psoriasis, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
Psoriasis patients are very poorly adherent to topical treatment. If adherence issues are ignored, poor adherence may limit the real-world efficacy of deucravacitinib, too. Forty psoriasis patients recruited from Wake Forest Baptist Health Dermatology Clinic will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- Text reminder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jul 2023to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with moderate-to-severe plaque psoriasis. Standard criteria for moderate-to-severe plaque psoriasis will be used (BSA greater than or equal to 3% or face/palm/sole/genital involvement or severe effect on Quality of Life).
- Subject must be 18 years of age or older.
- Subject must have a working knowledge of English.
- Approved birth control methods required for females of childbearing potential.
- Baseline TB test.
Who cannot join
- Patients without a diagnosis of moderate-to-severe plaque psoriasis.
- Patients under 18 years of age.
- Patients with severe or unstable comorbid conditions.
- Patients with active malignancy or malignancy in past 5 years (not including appropriately treated cutaneous basal and cutaneous-limited squamous cell carcinomas).
- Patients who are pregnant or breastfeeding.
- Patients with any other skin condition that prohibit or confound the ability of the investigator to interpret skin findings.
Show all 10Show fewer
- Patients with active substance or alcohol abuse disorder; or history of substance/alcohol abuse disorder within 6 months prior to study enrollment.
- History of, or active, severe depression and/or suicidality.
- Patients with active or latent tuberculosis as determined by quant-TB baseline testing
- Patients that are taking concomitant biologics, systemics for the treatment of psoriasis and/or phototherapy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences Department of Dermatology
Winston-Salem, North Carolina, 27157
About this study
Psoriasis patients are very poorly adherent to topical treatment. If adherence issues are ignored, poor adherence may limit the real-world efficacy of deucravacitinib, too. Forty psoriasis patients recruited from Wake Forest Baptist Health Dermatology Clinic will be enrolled. Twenty will be randomized to a reporting intervention designed to promote better adherence and the remaining 20 patients will serve as controls who will not receive a reporting intervention. Through qualitative interviews of the 40 patients recruited, we plan to study the behaviors of the most adherent patients to better understand specific beliefs and behaviors of adherent patients and to identify practical, modifiable factors that can improve adherence. We will also compare treatment outcomes and efficacy of deucravacitinib between the most and least adherence patients.
Read the detailed description
STUDY OBJECTIVES
- PRIMARY OBJECTIVE: The primary objective of the proposed study is to identify adherence outliers (high and low adherence), specific beliefs, and behaviors that correspond to better and worse adherence to oral treatment of psoriasis.
- SECONDARY OBJECTIVE: The investigators will study the efficacy and safety of deucravacitinib in patients who are highly adherent to treatment compared to patients who do not take the medication as directed (including both those who undertreat and overtreat).
- Safety endpoints will include reported adverse events.
- For the characterization of adherence to deucravacitinib, adherence endpoints will include the proportion of subjects with 80% or greater adherence, days with missed treatment, days with overuse, and premature discontinuation.
- Conditions
- Psoriasis
- Being tested
- Text reminder
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text reminderBehavioural
weekly text to remind use of drug
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | 50% of subjects will be randomized to a reporting tool designed to promote better adherence to treatment by having subjects report their progress on a weekly basis (the goal is not to test this tool but to help assure there is a broad range of adherence behavior including some positive adherence outliers) Receives: Behavioral: Text reminder |
| No Intervention | No intervention | 50% of subjects will not receive additional outreach to improve adherence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify Adherence to treatment
Qualitative data will be obtained from detailed, systematic interviews at 3-month follow-up to Adherence to treatment will be captured using electronic monitors that record the timing of medication dosing events and the number of pills taken at each event (based on weight of medication using Sensal Health adherence monitoring device) measured at 3 month close-out visit
Measured: 3 month close-out visit
Secondary outcomes (4)
Psoriasis Treatment Efficacy (PASI 75)
Compare psoriasis treatment outcomes between the most and least adherent patients
The primary measure of efficacy for comparing efficacy between high vs low adherence subjects will be percent of subjects with 75% improvement in Psoriasis Area and Severity Index (PASI 75).
Measured: baseline and 3 month close-out visit
Psoriasis Treatment Efficacy (PASI 90)
Compare psoriasis treatment outcomes between the most and least adherent patients
The primary measure of efficacy for comparing efficacy between high vs low adherence subjects will be percent of subjects with 90% improvement in Psoriasis Area and Severity Index (PASI 90).
Measured: baseline and 3 month close-out visit
Psoriasis Treatment Efficacy (PASI 100)
Compare psoriasis treatment outcomes between the most and least adherent patients
The primary measure of efficacy for comparing efficacy between high vs low adherence subjects will be percent of subjects with 100% improvement in Psoriasis Area and Severity Index (PASI 100).
Measured: baseline and 3 month close-out visit
Disease Clarity - Investigator's Global Assessment (IGA) Scale
Compare psoriasis treatment outcomes between the most and least adherent patients
The IGA is a five-point scale is a modified tool for evaluating plaque psoriasis severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD. A decrease in score relates to an improvement in signs and symptoms.
Measured: baseline and 3 month close-out visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start24 Jul 2023
- Primary completionNov 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will receive their medication with electronic monitors attached. 50% of those enrolled will receive reminders to take their medication the other 50% will not.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Steven R Feldman, MD, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570955
- Sponsor's protocol ID
- IRB00087852
- Status last verified
- Mar 2026
- First submitted
- 22 Sep 2022
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deucravacitinib Adherence Study
- ClinicalTrials.gov ID
- NCT05570955
- Acronym / sponsor ID
- IRB00087852
- Conditions
- Psoriasis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 24 Jul 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 7 Oct 2022 (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.
Psoriasis patients are very poorly adherent to topical treatment. If adherence issues are ignored, poor adherence may limit the real-world efficacy of deucravacitinib, too. Forty psoriasis patients recruited from Wake Forest Baptist Health Dermatology Clinic will be enrolled. Twenty will be randomized to a reporting intervention designed to promote better adherence and the remaining 20 patients will serve as controls who will not receive a reporting intervention. Through qualitative interviews of the 40 patients recruited, we plan to study the behaviors of the most adherent patients to better understand specific beliefs and behaviors of adherent patients and to identify practical, modifiable factors that can improve adherence. We will also compare treatment outcomes and efficacy of deucravacitinib between the most and least adherence patients.
Detailed description
STUDY OBJECTIVES
- PRIMARY OBJECTIVE: The primary objective of the proposed study is to identify adherence outliers (high and low adherence), specific beliefs, and behaviors that correspond to better and worse adherence to oral treatment of psoriasis.
- SECONDARY OBJECTIVE: The investigators will study the efficacy and safety of deucravacitinib in patients who are highly adherent to treatment compared to patients who do not take the medication as directed (including both those who undertreat and overtreat).
- Safety endpoints will include reported adverse events.
- For the characterization of adherence to deucravacitinib, adherence endpoints will include the proportion of subjects with 80% or greater adherence, days with missed treatment, days with overuse, and premature discontinuation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All participants will receive their medication with electronic monitors attached. 50% of those enrolled will receive reminders to take their medication the other 50% will not.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Text reminder50% of subjects will be randomized to a reporting tool designed to promote better adherence to treatment by having subjects report their progress on a weekly basis (the goal is not to test this tool but to help assure there is a broad range of adherence behavior including some positive adherence outliers) |
| No Intervention | No intervention | –50% of subjects will not receive additional outreach to improve adherence |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with moderate-to-severe plaque psoriasis. Standard criteria for moderate-to-severe plaque psoriasis will be used (BSA greater than or equal to 3% or face/palm/sole/genital involvement or severe effect on Quality of Life).
- Subject must be 18 years of age or older.
- Subject must have a working knowledge of English.
- Approved birth control methods required for females of childbearing potential.
- Baseline TB test.
Key exclusion criteria (10 listed)
- Patients without a diagnosis of moderate-to-severe plaque psoriasis.
- Patients under 18 years of age.
- Patients with severe or unstable comorbid conditions.
- Patients with active malignancy or malignancy in past 5 years (not including appropriately treated cutaneous basal and cutaneous-limited squamous cell carcinomas).
- Patients who are pregnant or breastfeeding.
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 |
|---|---|---|
| Text reminderweekly text to remind use of drug | Behavioural | Intervention |
Primary outcome
Identify Adherence to treatment
Time frame: 3 month close-out visit
Qualitative data will be obtained from detailed, systematic interviews at 3-month follow-up to Adherence to treatment will be captured using electronic monitors that record the timing of medication dosing events and the number of pills taken at each event (based on weight of medication using Sensal Health adherence monitoring device) measured at 3 month close-out visit
4 secondary outcomes
Psoriasis Treatment Efficacy (PASI 75)
Time frame: baseline and 3 month close-out visit
Psoriasis Treatment Efficacy (PASI 90)
Time frame: baseline and 3 month close-out visit
Psoriasis Treatment Efficacy (PASI 100)
Time frame: baseline and 3 month close-out visit
Disease Clarity - Investigator's Global Assessment (IGA) Scale
Time frame: baseline and 3 month close-out visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 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.
Steven R Feldman, MD, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text reminder in people with Psoriasis, run by Wake Forest University Health Sciences 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 5 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 31 Mar 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Identify Adherence to treatment (time frame: 3 month close-out visit). 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 31 Mar 2026.