Priming Intervention for Psoriasis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: IL-23 inhibitors

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

180 Participants Needed

Trial Summary

What is the purpose of this trial?

Biologic medications have revolutionized the treatment of inflammatory diseases such as moderate-to-severe psoriasis. Though very effective with an excellent safety profile, patients may be apprehensive about choosing a biologic medication for a variety of reasons. The purpose of this research study is to learn more about patient's perception of certain psoriasis treatment options.

Research Team

Steven R Feldman

Principal Investigator

Wake Forest University

Eligibility Criteria

This trial is for English-speaking individuals with psoriasis or their caregivers. It's not open to those who have already tried and did not respond well to specific biologic drugs like ustekinumab, guselkumab, risankizumab, or tildrakizumab.

Inclusion Criteria

Subjects with a working knowledge of English.

I have psoriasis or I am caring for someone with psoriasis.

Exclusion Criteria

I have tried or am currently on an IL-23 inhibitor like ustekinumab without success.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Survey Administration

Participants are randomized into three groups and administered surveys querying willingness to use a biologic medication

1 week

1 visit (virtual)

Follow-up

Participants are monitored for survey responses and willingness to use biologic medication

12 months

Treatment Details

Interventions

• Group #2 (Intervention)
• Group #3 (Intervention)

Trial Overview The study aims to understand how people with psoriasis feel about injectable biologic medications as a treatment option. Participants will be divided into groups receiving different educational interventions regarding these treatments.

Participant Groups

Group I: Group #3 (Intervention) Experimental Treatment 1 Intervention

Group #3 (Intervention) Survey 3 will be administered, and patients will be asked the following primer: Stelara® inhibits interleukin 23, one of the immune signaling molecules involved in psoriasis. People who are born with a genetic deficiency in the immune signal interleukin-23 are generally healthy, but also have a LOWER risk of getting immune diseases like psoriasis. What do you think would be the best way to describe this to a patient? 1. Stelara® acts in an almost all-natural way to help control psoriasis. 2. Stelara® blocks one of the genetic causes of psoriasis. 3. Stelara® makes psoriasis better by blocking the overactive signal that gets the immune system out of balance 4. Stelara® blocks interleukin-23, an important immune system signaling molecule involved in psoriasis How willing would you be to take Stelara® to treat your psoriasis, on a scale of (1 = definitely willing, 2 = probably willing, 3 = probably not willing, 4 = definitely not willing)

Group II: Group #2 (Intervention) Experimental Treatment 1 Intervention

Group #2 (Intervention) Survey 2 will be administered, and patients will be asked the following primer: Stelara® inhibits interleukin 23, one of the immune signaling molecules involved in psoriasis. People who are born with a genetic deficiency in the immune signal interleukin-23 are generally healthy, but also have a LOWER risk of getting immune diseases like psoriasis. How willing would you be to take Stelara® to treat your psoriasis, on a scale of (1 = definitely willing, 2 = probably willing, 3 = probably not willing, 4 = definitely not willing)

Group III: Group #1 (Control) Active Control 1 Intervention

Group #1 (Control) Oral survey 1 will be administered and patients will be asked: Stelara® inhibits interleukin 23, one of the immune signaling molecules involved in psoriasis. How willing would you be to take Stelara® to treat your psoriasis, on a scale of (1 = definitely willing, 2 = probably willing, 3 = probably not willing, 4 = definitely not willing)

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+