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Deucravacitinib Adherence Study

Primary Purpose

Psoriasis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text reminder
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Psoriasis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Wake Forest University Health Sciences Department of DermatologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Intervention

No Intervention

Arm 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)

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

Outcomes

Primary Outcome Measures

Identify Adherence to treatment
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 Outcome Measures

Psoriasis Treatment Efficacy (PASI 75)
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).
Psoriasis Treatment Efficacy (PASI 90)
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).
Psoriasis Treatment Efficacy (PASI 100)
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).
Disease Clarity - Investigator's Global Assessment (IGA) Scale
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.

Full Information

First Posted
September 22, 2022
Last Updated
July 31, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT05570955
Brief Title
Deucravacitinib Adherence Study
Official Title
Deucravacitinib Adherence Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 24, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Masking Description
Participants will not be told that the monitors attached to their medication is recording their usage
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Other
Arm 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)
Arm Title
No Intervention
Arm Type
No Intervention
Arm Description
50% of subjects will not receive additional outreach to improve adherence
Intervention Type
Behavioral
Intervention Name(s)
Text reminder
Intervention Description
weekly text to remind use of drug
Primary Outcome Measure Information:
Title
Identify Adherence to treatment
Description
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
Time Frame
3 month close-out visit
Secondary Outcome Measure Information:
Title
Psoriasis Treatment Efficacy (PASI 75)
Description
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).
Time Frame
baseline and 3 month close-out visit
Title
Psoriasis Treatment Efficacy (PASI 90)
Description
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).
Time Frame
baseline and 3 month close-out visit
Title
Psoriasis Treatment Efficacy (PASI 100)
Description
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).
Time Frame
baseline and 3 month close-out visit
Title
Disease Clarity - Investigator's Global Assessment (IGA) Scale
Description
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.
Time Frame
baseline and 3 month close-out visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irma M Richardson, MHA
Phone
336-716-2903
Email
irichard@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Feldman, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences Department of Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irma M Richardson, MHA
Phone
336-716-2903
Email
irichard@wakehealth.edu
First Name & Middle Initial & Last Name & Degree
Steven Feldman, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Deucravacitinib Adherence Study

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