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Trials / Active Not Recruiting

Active Not RecruitingNCT05570955

Deucravacitinib Adherence Study

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Wake Forest University Health Sciences · Academic / Other
Sex
All
Age
18 Years – 75 Years
Healthy volunteers
Not accepted

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.

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

Interventions

TypeNameDescription
BEHAVIORALText reminderweekly text to remind use of drug

Timeline

Start date
2023-07-24
Primary completion
2026-11-01
Completion
2027-03-01
First posted
2022-10-07
Last updated
2026-03-31

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05570955. Inclusion in this directory is not an endorsement.