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Active, Not Recruiting

NCT Number: NCT05570955

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Text reminder

Behavioral

weekly text to remind use of drug

Primary outcomes

  1. Identify Adherence to treatment

    Time frame: 3 month close-out visit

    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

Secondary outcomes

  1. Psoriasis Treatment Efficacy (PASI 75)

    Time frame: baseline and 3 month close-out visit

    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).

  2. Psoriasis Treatment Efficacy (PASI 90)

    Time frame: baseline and 3 month close-out visit

    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).

  3. Psoriasis Treatment Efficacy (PASI 100)

    Time frame: baseline and 3 month close-out visit

    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).

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

    Time frame: baseline and 3 month close-out visit

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 7, 2022
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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