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Study Summary
This trial will study how well a new drug, nemolizumab, works in treating children with moderate-to-severe eczema.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2018 Phase 2 trial • 226 Patients • NCT03100344Trial Design
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Who is running the clinical trial?
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- I am willing to stop taking certain medications for the trial.You have experienced severe pain during both the screening and baseline visits.I might need extra help for my atopic dermatitis soon.My skin condition affects more than 10% of my body.I agree to use a moisturizer and prescribed steroid cream as directed throughout the study.I have chronic bronchitis.You have tested positive for hepatitis B or C, or for HIV.My child has had chronic eczema for the required time before screening.Your IGA score is 3 or higher at both the screening and baseline visits.You have a history of certain immune system disorders, severe allergic reactions to immunoglobulin products, or can't tolerate specific types of skin medications.You have a weakened immune system.My body weight is under 10 kg.Your EASI score is 16 or higher at both the screening and baseline visits.
- Group 1: Cohort 1: Participants aged 7-11 years
- Group 2: Cohort 1.1: Participants aged 7-11 years
- Group 3: Cohort 2: Participants aged 2-6 years
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many institutions are currently overseeing this experimental trial?
"At the time of writing, 14 different medical centres are recruiting participants for this trial. Troy, Beaumont and New york have clinics involved but there are also other spots throughout the United States that may be closer to you- it is wise to pick a location near your home in order to reduce any travel strain associated with taking part."
Which individuals are authorized to partake in this exploration?
"The medical trial is open to 70 youths aged 2-12 suffering from dermatitis. The main criteria for eligibility include: an area of affected skin larger than 10% Body Surface Area (BSA) at both screening and baseline, a Peak Pruritus Numerical Rating Score of 4 or higher during the two visits, daily application of moisturizer as prescribed by their doctor with authorization to use topical corticosteroids if determined appropriate; compliance with all time requirements and procedural provisions specified in the clinical trial protocol, Eczema Area Severity Index score 16+ at both assessment points and Investigator Global Assessment score 3+ on those same occasions"
How many individuals are currently enrolled in this trial?
"Affirmative. Documents hosted on clinicaltrials.gov show that this medical research, posted on June 24th 2021, is actively in search of volunteers. 70 prospective participants must be sourced from 14 distinct locations."
Is this investigational trial open to participants under the age of eighty?
"The requirements for joining this medical trial dictate that participants must be aged between 2 to 12. There are 106 trials involving individuals under 18 years old, and 173 studies recruiting patients over the age of 65."
Has this investigation been done before or is it a pioneering effort?
"Nemolizumab's research has taken place since 2019, when the first Galderma R&D-sponsored trial was conducted with 750 participants. Its Phase 3 approval came shortly after and now there are 9 concurrent studies occurring in 228 cities across 25 nations."
What precedent has been established by other investigations involving Nemolizumab?
"At present, 9 clinical trials are assessing the efficacy of nemolizumab with 6 of those in phase 3. Primarily centered around Regensburg, Missouri, this medication is being tested at an impressive 959 different sites throughout the world."
What potential harms can arise from taking Nemolizumab?
"According to our team at Power, nemolizumab is believed to be relatively safe as there exists some data backing up its safety profile despite the lack of evidence for efficacy. This assessment resulted in a score of 2 on our 1-3 scale."
Are there still opportunities for individuals to take part in this research?
"Indeed, clinicaltrials.gov indicates that active recruitment for this trial is taking place. It was posted on June 24th 2021 and last updated on July 20th 2022, with 70 participants required from 14 different locations."
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