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Monoclonal Antibodies

Ustekinumab for Ichthyosis

Q: What clinical indications is Ustekinumab commonly prescribed for?

Ustekinumab is generally used to regulate the production of adrenal cortex hormones. It may additionally be prescribed as a last resort for conditions such as <a href="https://www.withpower.com/clinical-trials/psoriasis">psoriasis</a>, an inadequate response to one or more tnf antagonist therapies, and severe active <a href="https://www.withpower.com/clinical-trials/crohn&#x27;s-disease">Crohn's disease</a>.

Q: Can you elaborate on any other research trials that have utilized Ustekinumab?

Currently, 34 trials involving Ustekinumab are ongoing with 17 of those in the final stage. While Warsaw, Mazowieckie is one of the locations for these tests, 2820 other medical sites worldwide are also running studies about this drug.

Q: What is the upper limit of participants enrolled in this medical research?

That is correct. Clinicaltrials.gov reveals that this research trial, which was initiated on April 1st 2021, requires 15 participants and is currently looking for volunteers from one location.

Q: Are there any openings to join this clinical experiment?

Indeed, according to the information on clinicaltrials.gov this trial is currently enrolling patients. The initial posting was made April 1st 2021 and has been edited as recently as April 19th 2022. 15 individuals are being sought from a single site.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 months after initiation of study drug

Awards & highlights

Study Summary

This trial will test whether the drug ustekinumab is safe and effective for treating people with ichthyosis, a group of lifelong genetic disorders characterized by generalized skin thickening, scaling, and underlying cutaneous inflammation.

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

Select...

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

Select...

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

Select...

I have noticeable redness on my skin due to ichthyosis.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Urinary tract infection

Anxiety

Back pain

Dizziness

Fracture

Skin and subcutaneous tissue disorders

Rash/Rash Acneiform/Maculo-Papular

Hypertension

Pain/Pain in extremity

Toothache

100%

80%

60%

40%

20%

Study treatment Arm

Ustekinumab (Stelara)

Placebo (RCT Period)

Placebo (Active Treatment Period)

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

2013

Completed Phase 4

~4140

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Janssen Scientific Affairs, LLCIndustry Sponsor

159 Previous Clinical Trials

580,505 Total Patients Enrolled

Northwestern UniversityLead Sponsor

1,585 Previous Clinical Trials

917,218 Total Patients Enrolled

5 Trials studying Ichthyosis

1,198 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

2,669 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What clinical indications is Ustekinumab commonly prescribed for?

"Ustekinumab is generally used to regulate the production of adrenal cortex hormones. It may additionally be prescribed as a last resort for conditions such as psoriasis, an inadequate response to one or more tnf antagonist therapies, and severe active Crohn's disease."

Answered by AI

Can you elaborate on any other research trials that have utilized Ustekinumab?

"Currently, 34 trials involving Ustekinumab are ongoing with 17 of those in the final stage. While Warsaw, Mazowieckie is one of the locations for these tests, 2820 other medical sites worldwide are also running studies about this drug."

Answered by AI

What is the upper limit of participants enrolled in this medical research?

"That is correct. Clinicaltrials.gov reveals that this research trial, which was initiated on April 1st 2021, requires 15 participants and is currently looking for volunteers from one location."

Answered by AI

Are there any openings to join this clinical experiment?

"Indeed, according to the information on clinicaltrials.gov this trial is currently enrolling patients. The initial posting was made April 1st 2021 and has been edited as recently as April 19th 2022. 15 individuals are being sought from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Open-Label and Long-Term Extension Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Patients With Ichthyoses

Amy Paller 2021. "An Open-Label and Long-Term Extension Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Patients With Ichthyoses". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04549792.

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