Deucravacitinib Adherence Study

Psoriasis Clinical Trial

Official title:

Deucravacitinib Adherence Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05570955
• Other study ID #: IRB00087852
• Status: Recruiting
• Phase: N/A
• Start date: July 24, 2023
• Est. completion date: March 2025

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: Irma M Richardson, MHA
• Phone: 336-716-2903
• Email: irichard[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Behavioral:
• Text reminder
weekly text to remind use of drug

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences Department of Dermatology	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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