Deucravacitinib Adherence Study

Wake Forest University (WFU)

Status: Active, not recruiting

Conditions: Psoriasis

Treatments: Behavioral: Text reminder

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05570955

IRB00087852

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups

Intervention

Other group

Description:

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)

Treatment:

Behavioral: Text reminder

No Intervention

No Intervention group

Description:

50% of subjects will not receive additional outreach to improve adherence