Deucravacitinib Adherence 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.

Study Overview

• Status: Recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Behavioral: Text reminder

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Irma M Richardson, MHA; Phone Number: 336-716-2903; Email: irichard@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences Department of Dermatology
      • Principal Investigator: Steven Feldman, MD, PhD
      • Contact: Irma M Richardson, MHA; Phone Number: 336-716-2903; Email: irichard@wakehealth.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)	Behavioral: Text reminder; weekly text to remind use of drug
No Intervention: No Intervention; 50% of subjects will not receive additional outreach to improve adherence

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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.	baseline and 3 month close-out visit

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Steven R Feldman, MD, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: IRB00087852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No