Dupilumab SAR231893 for Eczema, Infantile

Phase-Based Estimates
3
Effectiveness
3
Safety
Investigational Site Number 8400001, Miami, FL
Eczema, Infantile+3 More
Dupilumab SAR231893 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Eczema, Infantile

Study Summary

Dupilumab Effect on Pruritus Neuro-mechanisms in Patients With Atopic Dermatitis

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Eligible Conditions

  • Eczema, Infantile
  • Dermatitis, Atopic
  • Pruritus
  • Dermatitis
  • Dermatitis Atopic

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Compared to trials

Study Objectives

This trial is evaluating whether Dupilumab SAR231893 will improve 15 secondary outcomes in patients with Eczema, Infantile. Measurement will happen over the course of Baseline to Week 21.

Baseline to Week 21
Incidence of treatment-emergent adverse events
Week 17
Change from baseline in the outcome of Atopic Dermatitis Control Tool (ADCT)
Change from baseline in the outcome of Patient Oriented Eczema Measure (POEM)
Change from baseline in the outcome of Patient Oriented Eczema Measure Dermatology Life Quality Index (DLQI)
Change from baseline in the outcome of Patient-Reported Outcomes Measurement Information (PROMIS-itch)
Change from baseline in the outcome of Skin Burning NRS
Change from baseline in the outcome of Skin Pain NRS
Change from baseline in the outcome of Skin Sensitivity NRS
Change from baseline in the outcome of Sleep quality NRS
Change from baseline in the outcome of eczema and severity index (EASI)
Change from baseline in the outcome of peak pruritus assessed by numeric rating scale (NRS)
Change from baseline in the outcome of scoring atopic dermatitis (SCORAD)
Week 3
Change from baseline in intraepidermal nerve fiber density
Change from baseline in nerve fiber branching
Week 3
Proportion of AD participants reaching pruritus NRS ≥4 point improvement from baseline

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Compared to trials

Trial Design

2 Treatment Groups

Control
Dupilumab

This trial requires 23 total participants across 2 different treatment groups

This trial involves 2 different treatments. Dupilumab SAR231893 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Dupilumab
Drug
Double dose on Day 1 and followed by single dose every 2 weeks (Q2W).
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dupilumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to weeks 3, 5, 9, 17, and 21
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline to weeks 3, 5, 9, 17, and 21 for reporting.

Closest Location

Investigational Site Number 8400001 - Miami, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
For Atopic dermatitis patients
Male or female of ≥18 years of age inclusive, at the time of signing the informed consent form (ICF).
Diagnosed with moderate-to-severe chronic AD for at least 1 year before screening.
Eligible to be treated with dupilumab according to product monograph.
Pruritus lasting 6 or more weeks before baseline (Day 1).
Eczema Area and Severity Index (EASI) score ≥12 at baseline.
Pruritus numerical rating scale (NRS) ≥4 at baseline.
Investigator global assessment (IGA) score of ≥3 at screening (on the 0 to 4 scale) at baseline.
Atopic dermatitis active lesions on the upper limbs or lower limbs suitable for a skin biopsy without oozing, bleeding, or infection on upper limbs or trunk.
Patients with acute AD lesions as determined by Investigator's judgment.

Patient Q&A Section

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

Can eczema, infantile be cured?

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In children with eczema, a child's skin should be reassessed every 6-8 weeks until signs of resolution have been documented. The child's skin should be monitored once a year for 2-3 years after resolution of the eczema. If the skin looks normal, children with eczema can be reassured that their eczema is resolved and can return to normal life.

Unverified Answer

What is eczema, infantile?

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Eczema, infantile, is a common condition where infants swell up, sometimes causing the skin to crack and bleed. It is more common in babies than adults and typically takes between 3 months and 2 years to get better. It is also very common, affects around 1% of babies or one in 250, which might be an underestimate, as some mothers do not complain about the condition. It is likely to set in later childhood or even late in life. It is not contagious. Eczema, infantile, can be diagnosed by a skin biopsy.

Unverified Answer

What are the signs of eczema, infantile?

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There is no one set of signs that is always present. Symptoms vary by patient. It is important to think of eczema in a holistic way as a disorder that manifests on different parts of the body at different times throughout a child's life. The same child may have the same eczema in different parts of their body, or different children may have different eczema on the same part of their body in the same child.

Unverified Answer

What are common treatments for eczema, infantile?

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Common treatments for eczema, infantile are topical corticosteroids, topical antifungal medications, oral or inhaled corticosteroids, antihistaminic treatments, or combinations of these. For severe, corticosteroid-refractory eczema, referral to a dermatologist is strongly advised.

Unverified Answer

How many people get eczema, infantile a year in the United States?

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There is a high rate of eczema in children in the United States, with nearly 3 percent and 13 percent of children having at least one and over two episodes, respectively, of eczema for 6 months or longer. The National Health and Nutrition Examination Survey (NHANES) reports an approximate national prevalence of 14 percent for eczema and its subtypes. The prevalence of eczema and its subtypes increases in the general population with increasing age and with increasing severity; however, the prevalence between races or ethnic groups is similar. Eczema, especially atopic dermatitis and total eczema, should be considered as potentially modifiable risk factors of increased incidence of some adult diseases, including cancer.

Unverified Answer

What causes eczema, infantile?

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Different factors, including genetics, early life infection and allergy, have been suggested as causes for eczema, infantile. These factors appear to interact with each other in order to cause the development of eczema in early childhood. The lack of understanding of the causes of eczema, infantile prevents the development of effective treatment and, therefore, the disease lasts a prolonged time in childhood.

Unverified Answer

What are the common side effects of dupilumab sar231893?

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The common side effects of dupilumab sar231893 include headache, insomnia, and headache worsened by use of opioids or alcohol. Dupilumab sar231893 also causes a rare, but serious, skin hypersensitivity reaction characterized by a pruritic rash, redness, swelling at the injection site, and inflammation. Dupilumab sar231893 should only be used if very clearly needed.

Unverified Answer

What is the average age someone gets eczema, infantile?

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In North American studies, the average age of diagnosis is 5.9 years. Other studies show the rate between 3 and 10 years. It is important to know how often a parent or baby gets eczema so that a doctor can diagnose it early.

Unverified Answer

Have there been other clinical trials involving dupilumab sar231893?

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This is the first report to mention dupilumab sar231893, an experimental therapy to block IL-23, in scientific journals. To our knowledge, this is the first report for dupilumab treatment in adults. We think that the potential benefit for patients who lack IL-12/23 activity justifies the development of more advanced therapies. Clinical trials are warranted for Dupilumab sar231893 in different diseases.

Unverified Answer

Who should consider clinical trials for eczema, infantile?

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The clinical trials for eczema are not accessible to people with eczema and are not tailored to the individual needs of each person with eczema. Doctors and nurses who care for people with eczema should be informed of the limitations of the limited information available in the published clinical trials and should be able to address those needs, as well as helping patients to obtain a well-informed decision on which trials to choose.

Unverified Answer

What is the primary cause of eczema, infantile?

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This is the first study that has identified, quantified, and associated an increased concentration of circulating immunoglobulin A in infants with eczema compared with in infants without eczema.

Unverified Answer

Have there been any new discoveries for treating eczema, infantile?

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All medications have limited efficacy in treating infantile eczema. There are no new discoveries for treating eczema during the past decade. It is an older disease. Several new medications are being tested in clinical trials for a possible future treatment.

Unverified Answer
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