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Monoclonal Antibodies

Nemolizumab for Eczema

Phase 2
Recruiting
Research Sponsored by Galderma R&D
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
AD involvement >=10% of BSA at both screening and baseline visits
Chronic AD documented for at least 6 months for participants aged 2-6 years and at least 1 year for participants aged 7-11 years before the screening visit and confirmed according to the American Academy of Dermatology Consensus Criteria at the time of the screening visit
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Awards & highlights

Study Summary

This trial will study how well a new drug, nemolizumab, works in treating children with moderate-to-severe eczema.

Who is the study for?
This trial is for children aged 2-11 with moderate-to-severe atopic dermatitis (eczema) lasting over 6 months to a year, depending on age. They must have certain severity scores, affected body area coverage, and agree to use moisturizers and topical steroids as directed. Children under 10 kg or with chronic bronchitis, certain infections like hepatitis B/C or HIV, immunosuppression issues, or known allergies to immunoglobulin products cannot participate.Check my eligibility
What is being tested?
The study tests Nemolizumab's effects on pediatric patients with severe eczema. It looks into how the drug moves inside the body (pharmacokinetics), its safety profile, and how effective it is in reducing eczema symptoms.See study design
What are the potential side effects?
While specific side effects of Nemolizumab are not listed here, similar medications can cause reactions at injection sites, increased risk of infections due to immune system changes, headaches, nausea and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My skin condition affects more than 10% of my body.
Select...
My child has had chronic eczema for the required time before screening.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Absorption Rate Constant (Ka) of Nemolizumab
Apparent Terminal Half-life (t1/2) of Nemolizumab
Apparent Total Body Clearance (Cl/F) of Nemolizumab
+7 more
Secondary outcome measures
Absolute Change From Baseline in Eczema Area and Severity Index (EASI) Score at Each Visit up to Week 52
Absolute Change From Baseline in Weekly Average of Average Pruritus Numeric Rating Scale (NRS) Score at Each Visit up to Week 52
Absolute Change From Baseline in Weekly Average of Peak Pruritus Numeric Rating Scale (PP NRS) Score at Each Visit up to Week 52
+18 more

Side effects data

From 2018 Phase 2 trial • 226 Patients • NCT03100344
33%
Nasopharyngitis
20%
Dermatitis atopic
13%
Headache
7%
Nausea
7%
Sinusitis
7%
Upper respiratory tract infection
5%
Diarrhoea
5%
Urinary tract infection
4%
Blood creatine phosphokinase increased
4%
Oral herpes
4%
Asthma
2%
Cough
2%
Back pain
2%
Arthralgia
2%
Cardio-respiratory arrest
2%
Pyrexia
2%
Abdominal pain
2%
Staphylococcal sepsis
2%
Asthenia
2%
Post-traumatic amnestic disorder
2%
Pneumonia aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Nemolizumab (10 mg)
Nemolizumab (90 mg)
Nemolizumab (30 mg)
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort 2: Participants aged 2-6 yearsExperimental Treatment1 Intervention
Participants aged 2-6 years will receive nemolizumab for 52 weeks.
Group II: Cohort 1: Participants aged 7-11 yearsExperimental Treatment1 Intervention
Participants aged 7-11 years will receive nemolizumab for 52 weeks.
Group III: Cohort 1.1: Participants aged 7-11 yearsExperimental Treatment1 Intervention
Participants aged 7-11 years will receive nemolizumab for 52 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nemolizumab
2021
Completed Phase 3
~2750

Find a Location

Who is running the clinical trial?

Galderma R&DLead Sponsor
299 Previous Clinical Trials
60,315 Total Patients Enrolled
12 Trials studying Eczema
4,098 Patients Enrolled for Eczema

Media Library

Nemolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04921345 — Phase 2
Eczema Research Study Groups: Cohort 1: Participants aged 7-11 years, Cohort 1.1: Participants aged 7-11 years, Cohort 2: Participants aged 2-6 years
Eczema Clinical Trial 2023: Nemolizumab Highlights & Side Effects. Trial Name: NCT04921345 — Phase 2
Nemolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04921345 — Phase 2

Frequently Asked Questions

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

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."

Answered by AI

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"

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~20 spots leftby Jan 2025