Clinical trial NCT05570955: Deucravacitinib Adherence Study
Official title: Deucravacitinib Adherence Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psoriasis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2022-10-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: OTHER

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Identify Adherence to treatment
timeFrame: 3 month close-out visit
Secondary outcomes:
measure: Psoriasis Treatment Efficacy (PASI 75)
timeFrame: baseline and 3 month close-out visit
measure: Psoriasis Treatment Efficacy (PASI 90)
timeFrame: baseline and 3 month close-out visit
measure: Psoriasis Treatment Efficacy (PASI 100)
timeFrame: baseline and 3 month close-out visit
measure: Disease Clarity - Investigator's Global Assessment (IGA) Scale
timeFrame: baseline and 3 month close-out visit
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences Department of Dermatology
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven R Feldman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: