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Deucravacitinib Adherence Study

NCT ID: NCT05570955

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-24

Study Completion Date

2026-08-31

Brief Summary

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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

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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

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants
Participants will not be told that the monitors attached to their medication is recording their usage

Study Groups

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Intervention

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)

Group Type OTHER

Text reminder

Intervention Type BEHAVIORAL

weekly text to remind use of drug

No Intervention

50% of subjects will not receive additional outreach to improve adherence

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Text reminder

weekly text to remind use of drug

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven R Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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IRB00087852

Identifier Type: -

Identifier Source: org_study_id