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

Trial Summary

What is the purpose of this trial?

The investigators propose to improve the possibility of reaching skin resolution by identifying certain markers or gene patterns that may predict patient response to certain psoriasis drugs ahead of time, thus eliminating or reducing the trial-and-error approach often employed. The ability to rule out (or in) specific therapeutics based on predictive efficacy would lead to a more personalized approach for psoriasis treatment. To do this, the investigators will be asking participants to try two different already on the market FDA-approved psoriasis drugs for 8 weeks at a time. The investigators will be monitoring participants skin for improvements as well as taking blood and skin samples at least three times. Investigators may also ask to take stool samples and/or skin swabs.

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 data supports the effectiveness of the drug Ustekinumab for treating psoriasis?

Ustekinumab has been shown to significantly improve psoriasis symptoms, with many patients achieving a 75% improvement in their condition after 12 weeks of treatment. It is also effective for those who did not respond to other treatments, and it generally has a good safety profile with mild side effects. ^{1 2 3 4 5}

Is ustekinumab generally safe for humans?

Ustekinumab (Stelara) is generally well tolerated in humans, with most side effects being mild and not requiring dosage changes. Serious infections or major heart-related issues are rare, and the safety profile remains stable even with long-term use. ^{1 2 5 6 7}

How does the drug ustekinumab work differently for psoriasis?

Ustekinumab is unique because it targets specific proteins (IL-12 and IL-23) involved in the immune response, which helps reduce the inflammation and skin symptoms of psoriasis. Unlike some other treatments, it is administered as an injection under the skin and can provide long-lasting relief with fewer doses. ^{2 3 4 5 8}

Research Team

Kevin Cooper, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

References

1. England 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. [2023]

2. New Zealand pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Staphylococcus aureus bacteremia with iliac artery endarteritis in a patient receiving ustekinumab. [2018]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Spotlight on ustekinumab in moderate to severe plaque psoriasis. [2016]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Ustekinumab: a review of its use in the management of moderate to severe plaque psoriasis. [2021]

6. France pubmed.ncbi.nlm.nih.gov

[Ustekinumab-induced eosinophilic pneumonia during the course of ustekinumab therapy for plaque psoriasis]. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

An update on the long-term safety experience of ustekinumab: results from the psoriasis clinical development program with up to four years of follow-up. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Long-term safety of ustekinumab for psoriasis. [2015]