Ustekinumab for Ichthyosis

Recruiting in Chicago (>99 mi)

Overseen By NU Dermatology CTU

Age: Any Age

Sex: Any

Trial Phase: Phase < 1

Sponsor: Northwestern University

Must not be taking: Systemic retinoids, Anti-inflammatories, Topical steroids

Disqualifiers: Ichthyosis vulgaris, X-linked ichthyosis, others

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

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

Compensation: Varies

Number of Visits: Unknown

Duration: 7 months

13 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests ustekinumab, a medication that reduces inflammation, on children (6 years and older) and adults with severe skin conditions called ichthyotic disorders. The medication works by blocking specific proteins to reduce inflammation and improve symptoms. Ustekinumab has been used effectively in treating various severe skin conditions, including psoriasis and hidradenitis suppurativa.

Will I have to stop taking my current medications?

The trial requires that you stop using any systemic retinoid or systemic anti-inflammatory agent at least 4 weeks before starting, and you must not use topical steroids in the week before starting or retinoid or keratolytic agents in the 24 hours before starting.

What data supports the effectiveness of the drug ustekinumab for treating ichthyosis?

Ustekinumab has been shown to be effective in treating moderate to severe plaque psoriasis and psoriatic arthritis, as well as other skin conditions like atopic dermatitis and hidradenitis suppurativa, suggesting it may help with ichthyosis due to its ability to modulate the immune system. ^{1 2 3 4 5}

Is Ustekinumab generally safe for humans?

Ustekinumab, also known as Stelara, is generally considered safe for treating conditions like psoriasis, Crohn's disease, and inflammatory bowel diseases, though some adverse effects like eosinophilic pneumonia have been reported. In various studies, it has shown promise in treating skin conditions, but monitoring for adverse events is important. ^{5 6 7 8 9}

How is the drug ustekinumab different from other treatments for ichthyosis?

Ustekinumab is unique because it targets specific proteins (IL-12 and IL-23) involved in immune system signaling, which is different from other treatments that may not focus on these pathways. It is administered as a subcutaneous injection, which can be more convenient compared to other forms of treatment. ^{1 2 3 4 10}

Research Team

Amy Paller, MD

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for children (6+) and adults with ichthyosis who have not used certain medications targeting IL-12/IL-23, steroids, or retinoids within specific time frames before the study. Participants must test negative for TB, Hepatitis B/C, HIV, be immunocompetent and agree to contraception requirements.

Inclusion Criteria

I am a man who can father children and will use contraception during and 16 weeks after the study.

You need to have a negative test for tuberculosis, hepatitis B, hepatitis C, and HIV before starting the study.

I am either postmenopausal or, if of childbearing age, I am following specific contraceptive guidelines.

Exclusion Criteria

I am not pregnant, breastfeeding, nor planning to become pregnant.

I am under 6 years old.

I can give my own consent or have someone legally allowed to do so if I'm under 18.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ustekinumab to assess clinical response and safety for ichthyotic disorders

7 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may continue to receive ustekinumab to evaluate long-term efficacy and safety

Treatment Details

Interventions

• Ustekinumab

Trial Overview The trial tests Ustekinumab's effectiveness in treating ichthyoses by reducing skin inflammation. It's an open-label study where all participants know they're receiving the drug. The goal is to see if this treatment can improve their quality of life.

Participant Groups

Group I: Open Label Experimental Treatment 1 Intervention

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?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Janssen Scientific Affairs, LLC

Industry Sponsor

Trials

165

Recruited

579,000+

Ricardo Attar

Janssen Scientific Affairs, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology, University of Buenos Aires

Dr. Anastasia G. Daifotis

Janssen Scientific Affairs, LLC

Chief Medical Officer since 2023

MD

Findings from Research

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]

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]

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 (STELARA) is a safe and effective treatment for skin conditions related to inflammatory bowel diseases (IBD), including metastatic Crohn's disease and pyoderma gangrenosum, based on a review of 22 articles.

It also effectively addresses paradoxical skin reactions caused by TNF-α inhibitors, such as psoriasis, particularly when these reactions do not improve with standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ustekinumab for the treatment of paradoxical skin reactions and cutaneous manifestations of inflammatory bowel diseases. Wu, J., Smogorzewski, J.[2021]

References

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

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

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

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

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

5. Germany pubmed.ncbi.nlm.nih.gov

Alternative uses of ustekinumab for non-indicated dermatological conditions: a systematic review. [2022]

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

Ustekinumab for the treatment of paradoxical skin reactions and cutaneous manifestations of inflammatory bowel diseases. [2021]

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

A phase 1b open-label dose-finding study of ustekinumab in young adults with type 1 diabetes. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

IL12/23 Blockade with Ustekinumab as a Treatment for Immune-Related Cutaneous Adverse Events. [2023]

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

Ustekinumab: a review in the treatment of plaque psoriasis and psoriatic arthritis. [2015]