What side effects are associated with this type of intervention?

Common treatments for ichthyosis include topical therapies, systemic retinoids, and biologics like IL-12/IL-23 inhibitors. Ustekinumab, an IL-12/IL-23 inhibitor, is being studied for its efficacy in treating ichthyosis. Known side effects of IL-12/IL-23 inhibitors include increased risk of infections, headache, fatigue, and injection site reactions. Systemic retinoids, another common treatment, can cause mucocutaneous side effects, elevated serum lipids, and, in some cases, severe paronychia. Topical therapies generally have fewer systemic side effects but can cause local irritation and skin thinning.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically targeting the IL-12/IL-23 pathways for Ichthyosis. Ustekinumab, an IL-12/IL-23 inhibitor, is being studied for its potential benefits in treating this condition due to its success in managing similar inflammatory pathways in psoriasis. Traditional treatments for Ichthyosis primarily focus on symptomatic relief through topical emollients, keratolytics, and systemic retinoids.

What other types of research exist?

Promising novel alternatives to Ustekinumab for Ichthyosis patients include IL-23 inhibitors like Guselkumab and Risankizumab, and IL-17 inhibitors such as Secukinumab and Ixekizumab. These treatments target similar inflammatory pathways and have shown efficacy in related skin conditions.

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Monoclonal Antibodies

Ustekinumab for Ichthyosis

Q: What is the mechanism of action of this treatment?

The most common treatments for Ichthyosis focus on managing skin thickening, scaling, and inflammation. Ustekinumab, an IL-12/IL-23 inhibitor, targets the Th17/IL-23 pathway, which is implicated in the inflammatory processes of Ichthyosis. By inhibiting these cytokines, Ustekinumab can reduce inflammation and potentially improve skin symptoms. This is significant for Ichthyosis patients as it offers a targeted approach to managing the underlying inflammation, potentially improving their quality of life and reducing the social and physical burdens of the disease.

Phase < 1

Waitlist Available

Led By Amy Paller, MD

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Before screening visit, females must be postmenopausal or of childbearing potential and meet specific contraceptive requirements

Subjects must have a confirmed clinical diagnosis of ichthyosis/ichthyotic disorder, and either have completed genotype or be willing to be genotyped

Must not have

Female subjects who are pregnant or breastfeeding, or who are considering becoming pregnant

Subjects who are under 6 years of age at the time of screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 months after initiation of study drug

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Ustekinumab may cause side effects such as infections due to immune system suppression, allergic reactions to its components, and potentially other unknown risks since it targets pathways involved in inflammatory skin conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I have been diagnosed with ichthyosis and am willing to undergo genetic testing.

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I have noticeable redness on my skin due to ichthyosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am under 6 years old.

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

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I have previously used medication targeting IL-12/IL-23.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 months after initiation of study drug

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 months after initiation of study drug

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 months after initiation of study drug for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurence of bacterial and fungal infections

Reduction in Ichthyosis Severity Score

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172

50%

Upper respiratory infection

27%

Common cold

Skin and subcutaneous tissue disorders

Fracture

Anxiety

Dizziness

Back pain

Urinary tract infection

Toothache

Rash/Rash Acneiform/Maculo-Papular

Hypertension

Pain/Pain in extremity

100%

80%

60%

40%

20%

Study treatment Arm

Ustekinumab (Stelara)

Placebo (RCT Period)

Placebo (Active Treatment Period)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Open LabelExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ustekinumab

2015

Completed Phase 4

~4080

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Ichthyosis focus on managing skin thickening, scaling, and inflammation. Ustekinumab, an IL-12/IL-23 inhibitor, targets the Th17/IL-23 pathway, which is implicated in the inflammatory processes of Ichthyosis. By inhibiting these cytokines, Ustekinumab can reduce inflammation and potentially improve skin symptoms. This is significant for Ichthyosis patients as it offers a targeted approach to managing the underlying inflammation, potentially improving their quality of life and reducing the social and physical burdens of the disease.

Treatment of facial actinic keratoses with aminolevulinic acid photodynamic therapy (ALA-PDT) or ingenol mebutate 0.015% gel with and without prior treatment with ALA-PDT.Long-term ustekinumab treatment for refractory type I pityriasis rubra pilaris.