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Monoclonal Antibodies

Ustekinumab for Ichthyosis

Chicago, IL
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.

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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.Check my eligibility
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.See study design
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.
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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.
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Timeline

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 Total Ichthyosis Severity Score

Side effects data

From 2018 Phase 4 trial • 43 Patients • NCT02187172
50%
Upper respiratory infection
27%
Common cold
9%
Fracture
9%
Skin and subcutaneous tissue disorders
9%
Anxiety
9%
Dizziness
9%
Back pain
9%
Urinary tract infection
5%
Toothache
5%
Hypertension
5%
Pain/Pain in extremity
5%
Rash/Rash Acneiform/Maculo-Papular
100%
80%
60%
40%
20%
0%
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

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.

Find a Location

Closest Location:Northwestern University/Lurie Children's Hospital· Chicago, IL

Who is running the clinical trial?

Janssen Scientific Affairs, LLCIndustry Sponsor
164 Previous Clinical Trials
579,428 Total Patients Enrolled
Northwestern UniversityLead Sponsor
1,663 Previous Clinical Trials
970,686 Total Patients Enrolled
6 Trials studying Ichthyosis
1,242 Patients Enrolled for Ichthyosis
Amy Paller, MDPrincipal Investigator - Northwestern University
Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern Memorial Hospital
Stanford University School Of Medicine (Medical School)
Northwestern Mem Hospital (Residency)
17 Previous Clinical Trials
2,676 Total Patients Enrolled
2 Trials studying Ichthyosis
963 Patients Enrolled for Ichthyosis

Media Library

Ustekinumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04549792 — Phase < 1
Ichthyosis Research Study Groups: Open Label
Ichthyosis Clinical Trial 2023: Ustekinumab Highlights & Side Effects. Trial Name: NCT04549792 — Phase < 1
Ustekinumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04549792 — Phase < 1
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