Deucravacitinib Adherence Study

NCT05570955 | Active Not Recruiting

• 1 other identifier: IRB00087852
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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

  3 month close-out visit

Secondary Outcomes (4)

• Psoriasis Treatment Efficacy (PASI 75)

  baseline and 3 month close-out visit

• Psoriasis Treatment Efficacy (PASI 90)

  baseline and 3 month close-out visit

• Psoriasis Treatment Efficacy (PASI 100)

  baseline and 3 month close-out visit

• Disease Clarity - Investigator's Global Assessment (IGA) Scale

  baseline and 3 month close-out visit

Study Arms (2)

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)

Behavioral: Text reminder

No Intervention

NO INTERVENTION

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

Interventions

Text reminder BEHAVIORAL

weekly text to remind use of drug

Intervention

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Steven R Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told that the monitors attached to their medication is recording their usage
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 7, 2022
• Study Start: July 24, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)