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Monoclonal Antibodies
dupilumab for Eczema (NEURADAD Trial)
Phase 4
Waitlist Available
Research Sponsored by Regeneron Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 16
Awards & highlights
NEURADAD Trial Summary
This trial has two parts. In Part A, they are testing how well a certain test can measure cognitive function in teens with moderate to severe AD. In Part B, they are testing how well dupilumab (a medication) works in improving cognitive function in teens with moderate to severe AD.
Eligible Conditions
- Eczema
NEURADAD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Mean change from baseline in Conner's CPT-3 d' T-score
Proportion of AD patients with a Conner's CPT-3 d' T-score ≥ 60
Secondary outcome measures
Correlation of change in AD disease severity based on BSA with AASP Sensory Sensitivity Summary Score
Correlation of change in AD disease severity based on BSA with change in Conners' CPT-3 score
Correlation of change in AD disease severity based on CDLQI with AASP Sensory Sensitivity Summary Score
+38 moreSide effects data
From 2023 Phase 4 trial • 40 Patients • NCT042037975%
Asthma
5%
Sinus pain
5%
Injection site erythema
5%
Rhinitis
5%
Cough
5%
Immunisation reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dupilumab 300 mg Q2W
Placebo
NEURADAD Trial Design
2Treatment groups
Experimental Treatment
Group I: Part BExperimental Treatment1 Intervention
Patients in Part A may also enroll in Part B provided they meet the eligibility criteria.
Group II: Part AExperimental Treatment0 Interventions
Assessed in a single visit and no study-related treatment will be given.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
dupilumab
2022
Completed Phase 4
~330
Find a Location
Who is running the clinical trial?
Regeneron PharmaceuticalsLead Sponsor
628 Previous Clinical Trials
382,197 Total Patients Enrolled
35 Trials studying Eczema
13,323 Patients Enrolled for Eczema
SanofiIndustry Sponsor
2,171 Previous Clinical Trials
3,517,049 Total Patients Enrolled
42 Trials studying Eczema
15,886 Patients Enrolled for Eczema
Clinical Trial ManagementStudy DirectorRegeneron Pharmaceuticals
266 Previous Clinical Trials
252,267 Total Patients Enrolled
20 Trials studying Eczema
10,702 Patients Enrolled for Eczema
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have skin conditions that might make it difficult to accurately assess your condition in the study.You have been diagnosed by a doctor with conditions like ADHD, autism, epilepsy, major depression, bipolar disorder, or schizophrenia.You have used drugs or alcohol, including cigarettes, heavily in the past two years.You experience severe itching with a score of 4 or higher on a scale. This will be checked during your visits as specified in the study guidelines.
Research Study Groups:
This trial has the following groups:- Group 1: Part A
- Group 2: Part B
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
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