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Deucravacitinib Adherence Study

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05570955
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Wake Forest University Health Sciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Steven R Feldman, MD, PhD
Principal Investigator Affiliation Wake Forest University Health Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other, Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Other: Intervention

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)

No Intervention: No Intervention

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

Interventions

Behavioral: - Text reminder

weekly text to remind use of drug

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157

Site Contact

Irma M Richardson, MHA

irichard@wakehealth.edu

336-716-2903

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