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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand patients' perspectives on using the biologic medication Stelara® for treating moderate-to-severe psoriasis. Participants will complete surveys about their willingness to take Stelara® after receiving various pieces of information about its mechanism. The trial seeks individuals diagnosed with psoriasis or those caring for someone with psoriasis who are comfortable with English. Participants should not have previously used similar medications. This study will assist doctors in better communicating treatment options to patients. As an unphased trial, it offers participants the chance to contribute to enhancing patient-doctor communication and treatment understanding.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Stelara® (ustekinumab) is safe for treating psoriasis. In studies involving more than 3,000 people with psoriasis, many used Stelara® for several months to a year. The treatment was well-tolerated, with no harmful effects related to the dose or long-term use. Although it can weaken the immune system's ability to fight infections, the side effects were generally mild and remained consistent over time. Overall, Stelara® has proven safe and effective for many patients with moderate to severe psoriasis. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how priming information can influence patients' willingness to use Stelara®, a treatment for psoriasis. Unlike standard treatments that focus solely on physical effects, this trial investigates the power of perception and understanding in treatment acceptance. By examining different ways to present information about Stelara®'s mechanism—blocking interleukin 23, an immune signal tied to psoriasis—the study aims to uncover how patients' attitudes can be shaped. This could lead to more personalized and effective communication strategies in healthcare, potentially improving treatment adherence and outcomes.

What evidence suggests that this trial's treatments could be effective for psoriasis?

Studies have shown that Stelara, also known as ustekinumab, effectively treats psoriasis. In clinical trials, 7 out of 10 people using Stelara experienced at least 75% clearer skin after 12 weeks. Additionally, 80.55% of patients who had tried other medications before responded well to Stelara. This treatment blocks a part of the immune system called interleukin-23, which is involved in psoriasis. People with naturally lower levels of this molecule tend to have a reduced risk of immune diseases like psoriasis, explaining how Stelara can help manage the condition. Participants in this trial will be divided into groups to assess their willingness to use Stelara based on different informational primers about the drug's mechanism. ^{6 7 8 9 10}

Who Is on the Research Team?

Steven R Feldman

Principal Investigator

Wake Forest University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2915500/

Ustekinumab: an evidence-based review of its ... Psoriasis measures were also reduced with ustekinumab treatment. Results from this trial show that ustekinumab is efficacious for the treatment of active PsA.

2. jnjmedicalconnect.com jnjmedicalconnect.com/products/stelara/medical-content/stelara-overview-of-clinical-data-from-phoenix-1-and-phoenix-2

STELARA - Overview of Clinical Data from PHOENIX 1 and ... In both trials, significantly more patients receiving 45 mg and 90 mg achieved the primary endpoint of ≥75% improvement from baseline in ...

3. stelarainfo.com stelarainfo.com/plaque-psoriasis/treatment-information/treatment-results/

Psoriasis Treatment Results | STELARA® (ustekinumab) 7 out of 10 people taking STELARA® saw at least 75% clearer skin at 12 weeks. STELARA® Clinical Results 6 out of 10 people had their plaque psoriasis rated as ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/09546634.2023.2241941

Full article: Effectiveness and safety of ustekinumab for the ... We determined 80.55% of the non-naïve cases responded to ustekinumab. Conclusion. Ustekinumab can be a suitable treatment option for non-naïve and resistant ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05335356

Comparing Efficacy and Safety of Bmab 1200 and Stelara ... Approximately 384 patients with moderate to severe plaque psoriasis will be enrolled and randomly assigned to one of the 2 treatment groups in a 1:1 ratio ...

6. stelarainfo.com stelarainfo.com/safety

Important Safety Information | STELARA® (ustekinumab) STELARA® may lower your ability to fight infections and may increase your risk of infections. Some people have serious infections during treatment with STELARA® ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30739254/

Ustekinumab Safety in Psoriasis, Psoriatic Arthritis, and ... Conclusions: Ustekinumab demonstrated a favorable and consistent safety profile across registrational trials in approved indications. Trial registrations: ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2022/761044s010lbl.pdf

STELARA® (ustekinumab) - accessdata.fda.gov The safety data reflect exposure to STELARA® in 3117 adult psoriasis subjects, including 2414 exposed for at least 6 months, 1855 exposed for at least one year, ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23301632/

Long-term safety of ustekinumab in patients with moderate- ... Conclusions: No dose-related or cumulative toxicity was observed with increasing duration of ustekinumab exposure for up to 5 years. Rates of AEs reported in ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S1567576925003297

A real-world analysis based on the FDA adverse event ... Multiple clinical trials have demonstrated excellent efficacy and safety of UST in biotherapeutic patients with moderate to severe psoriasis [[ ...