Ustekinumab for Psoriasis

Overseen By Amy Johnson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University Hospitals Cleveland Medical Center

Must not be taking: Topical steroids, Systemic therapy

Disqualifiers: Pregnancy, Psoriatic arthritis, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

56 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to treat plaque-type psoriasis, a skin condition that causes red, scaly patches. Researchers seek to determine if certain genetic markers can predict a person's response to specific psoriasis medications, making treatment more personalized and effective. Participants will try two FDA-approved psoriasis drugs, including Ustekinumab (Stelara), testing each for eight weeks while researchers monitor skin improvements and collect samples. Those diagnosed with plaque-type psoriasis who have not previously used the trial medications may be a good fit if they have insurance covering these treatments and psoriasis affecting at least 10% of their body. As a Phase 4 trial, this study involves FDA-approved treatments and aims to understand how these effective medications can benefit more patients.

Will I have to stop taking my current medications?

Yes, you will need to stop using any topical treatments like steroids, tar, Vitamin D, or retinoids at least 2 weeks before starting the trial and throughout its duration. You also need to stop any systemic or biologic therapies at least 8 weeks before the trial begins.

What is the safety track record for these treatments?

Research has shown that ustekinumab is generally safe for treating psoriasis, with most patients tolerating it well. A long-term study with Swedish patients found no major heart-related safety issues when comparing ustekinumab to another common treatment.

Real-world data from the FDA also supports its safety, with no unexpected side effects reported for psoriasis and psoriatic arthritis. Additionally, a five-year study demonstrated consistent safety and effectiveness for patients using ustekinumab, suggesting it is a reliable option for long-term use.

In summary, ustekinumab has a strong safety record for treating psoriasis, supported by extensive research and real-world data. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about ustekinumab for psoriasis because it targets a specific part of the immune system called interleukin-12 and interleukin-23, which are proteins involved in inflammatory responses. Unlike traditional treatments like methotrexate or topical steroids, which can affect a broader range of bodily functions, ustekinumab focuses more precisely on the pathways that lead to psoriasis. This targeted approach has the potential to reduce side effects and improve efficacy. Additionally, after initial treatment with ustekinumab, patients may switch to guselkumab or risankizumab, both of which further target interleukins, allowing for a personalized approach depending on patient response.

What is the effectiveness track record for Ustekinumab in treating psoriasis?

Research has shown that ustekinumab effectively treats psoriasis. Studies have found that 7 out of 10 people using ustekinumab experienced at least a 75% improvement in skin clearance within 12 weeks. It has also remained effective for up to 5 years with continued use. Other studies have shown that over 80% of patients who had tried other treatments responded well to ustekinumab. This trial will initially treat participants with ustekinumab, followed by either guselkumab or risankizumab, to evaluate their effectiveness in improving skin conditions in people with psoriasis. ^{4 6 7 8 9}

Who Is on the Research Team?

Kevin Cooper, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with plaque-type psoriasis covering at least 10% of their body, who have not used certain biologics or other psoriasis treatments recently. Participants must have insurance that covers the study drugs and be able to give informed consent. Those with psoriatic arthritis, recent use of tanning booths, or women who are pregnant or breastfeeding cannot join.

Inclusion Criteria

My insurance covers Stelara and either Tremfya or Skyrizi.

I have been diagnosed with plaque-type psoriasis by a skin specialist or through a biopsy.

I have never been treated with ustekinumab, guselkumab, or risankizumab.

Exclusion Criteria

I have psoriatic arthritis or another similar condition like Crohn's disease.

You haven't used tanning booths for at least 4 weeks before the study starts.

I cannot get ustekinumab, gusekumab, or risankizumab for the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment with Ustekinumab

Participants receive ustekinumab (90mg at week 0 and week 4 by subcutaneous injection) for 8 weeks

8 weeks

2 visits (in-person)

Treatment with Guselkumab or Risankizumab

Participants receive guselkumab (100mg at week 0 and week 4 by subcutaneous injection) or risankizumab (150mg at week 0 and week 4 by subcutaneous injection) for 8 weeks

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ustekinumab

Trial Overview

The trial aims to personalize psoriasis treatment by predicting responses to FDA-approved drugs Ustekinumab and others using gene patterns. Participants will try two different drugs over periods of 8 weeks while undergoing skin improvement monitoring and providing blood, stool, and skin samples.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Patients will be treated with ustekinumab (90mg at week 0 and week 4 by subcutaneous injection) for 8 weeks followed by treatment with guselkumab (100mg at week 0 and week 4 by subcutaneous injection) or risankizumab (150mg at week 0 and week 4 by subcutaneous injection)

Ustekinumab is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Stelara for:

• Moderate to severe plaque psoriasis
• Psoriatic arthritis
• Crohn's disease
• Ulcerative colitis

Approved in United States as Stelara for:

• Moderate to severe plaque psoriasis
• Active psoriatic arthritis
• Moderately to severely active Crohn's disease
• Moderately to severely active ulcerative colitis

Approved in Canada as Stelara for:

• Moderate to severe plaque psoriasis
• Active psoriatic arthritis
• Moderately to severely active Crohn's disease
• Moderately to severely active ulcerative colitis

Approved in Japan as Stelara for:

• Plaque psoriasis
• Psoriatic arthritis
• Crohn's disease
• Ulcerative colitis

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

LEO Foundation

Collaborator

Trials

1

Recruited

60+

Case Western Reserve University

Collaborator

Trials

314

Recruited

236,000+

Published Research Related to This Trial

A 71-year-old male patient developed eosinophilic pneumonia after being treated with ustekinumab for severe psoriasis, highlighting a potential adverse effect of this medication.

After discontinuing ustekinumab and starting corticosteroid treatment, the patient's symptoms resolved, indicating that eosinophilic pneumonia can improve with treatment withdrawal and corticosteroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ustekinumab-induced eosinophilic pneumonia during the course of ustekinumab therapy for plaque psoriasis]. Amy de la Bretèque, M., Appere-De Vecchi, C., Zeboulon, C., et al.[2015]

The study found that AVT04, a biosimilar to ustekinumab (Stelara®), demonstrated therapeutic equivalence in treating moderate-to-severe chronic plaque psoriasis, with similar efficacy as shown by a percent improvement in the psoriasis area and severity index (PASI) of 87.3% for AVT04 compared to 86.8% for the reference product.

Safety and tolerability profiles were comparable between AVT04 and the reference product throughout the 52-week study, with no clinically meaningful impact from the incidence of antibodies to ustekinumab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, double-blind, multicenter study to evaluate efficacy, safety, tolerability, and immunogenicity between AVT04 and the reference product ustekinumab in patients with moderate-to-severe chronic plaque psoriasis. Feldman, SR., Reznichenko, N., Berti, F., et al.[2023]

Ustekinumab is a highly effective treatment for moderate-to-severe psoriasis, showing better efficacy rates compared to traditional therapies, based on a review of literature up to April 2013.

The biologic has a favorable safety profile and dosing schedule, making it a suitable option for patients with difficult-to-treat psoriasis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety of ustekinumab for psoriasis. Kumar, N., Narang, K., Cressey, BD., et al.[2015]

Ustekinumab is an effective treatment for adults with active psoriatic arthritis, showing significant improvement compared to placebo in phase 3 trials, with benefits maintained up to 100 weeks.

The drug has a favorable safety profile, with rare occurrences of serious infections or major cardiovascular events, making it a valuable option for patients who do not respond to traditional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ustekinumab: a review of its use in psoriatic arthritis. McKeage, K.[2021]

This case report highlights a rare instance of severe Staphylococcus aureus infection in a 64-year-old woman who had recently received ustekinumab for psoriatic arthritis, suggesting that while ustekinumab is generally safe, clinicians should remain vigilant for potential severe infections in patients on biological therapies.

The report emphasizes the importance of ongoing monitoring for rare but serious infections in patients treated with biologicals like ustekinumab, as symptoms may be nonspecific and fever may not always be present, necessitating thorough investigation when inflammatory markers are elevated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staphylococcus aureus bacteremia with iliac artery endarteritis in a patient receiving ustekinumab. Joost, I., Steinfurt, J., Meyer, PT., et al.[2018]

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.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/25307931/

results from the PHOENIX 2 study through 5 years of follow ...

Treatment with ustekinumab for up to 5 years was safe and effective. Improved response was generally demonstrated following dosing adjustments.

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.

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 ...

5.

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 ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40089022/

Long-term cardiovascular safety of ustekinumab in ...

This nationwide study of Swedish PsO/PsA patients spanning >10 years found no evidence of different CV safety profiles of ustekinumab versus adalimumab, ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S1567576925003297

A real-world analysis based on the FDA adverse event ...

The safety assessment of ustekinumab on psoriasis and psoriatic arthritis: A real-world analysis based on the FDA adverse event reporting ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05335356

Comparing Efficacy and Safety of Bmab 1200 and Stelara ...

Efficacy and safety of the ustekinumab biosimilar, Bmab 1200, versus reference ustekinumab in moderate-to-severe plaque psoriasis: 28-week results of the ...

9.

jnj.com

jnj.com/media-center/press-releases/new-stelara-five-year-data-show-consistent-efficacy-and-safety-profile-in-treatment-of-moderate-to-severe-plaque-psoriasis

New STELARA® Five-Year Data Show Consistent Efficacy ...

Investigators also reported a consistent benefit-to-risk profile for STELARA through five years and observed treatment with the biologic therapy ...