Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Regeneron Pharmaceuticals
With
Sanofi
Per protocol Study Stop Criteria, study has concluded with Part A. Part B was not initiated and no data were collected.
Age
12–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Adolescent (12 - 17 years of age) Part A: at time of visit Part B: at time of screening visit
2. Diagnosis of atopic dermatitis (AD) according to American Academy of Dermatology consensus criteria; chronic AD Part A: first diagnosed at least 1 year prior to visit Part B: first diagnosed at least 1 year prior to the screening visit
3. EASI score ≥ 12 Part A: at time of visit Part B: at screening and baseline visits
4. IGA score ≥ 3 Part A: at time of visit Part B: at time of screening and baseline visits
5. Peak Pruritus NRS score ≥ 4 Part A: at time of visit Part B: at time of screening and baseline visits as defined in the protocol
6. The CPT-3 d' score for entry into Part B will be determined based on the distribution of the CPT-3 d' score from Part A
7. BSA of AD involvement ≥ 10% Part A: at time visit Part B: at screening and baseline visits
8. Part B Only: Documented recent history (within 6 months of the screening visit) of inadequate response (in the opinion of the investigator) to topical AD medication(s) or for whom topical AD medications are medically inadvisable as defined in the protocol
9. Part B Only: Patient's stable use of a prescription topical medication regimen for AD lesions for at least 2 weeks prior to baseline as defined in the protocol
You may not be if
1. Prior use of dupilumab Part A: within 6 months of visit Part B: within 6 months of screening
2. Skin diseases that could confound AD assessment as defined in the protocol
3. Treatment with methylphenidate, dexmethylphenidate, serdexmethylphenidate, amphetamine, dextroamphetamine, lisdexamfetamine, guanfacine, atomoxetine, clonidine, or viloxazine within 8 weeks or within 5 half-lives, whichever is longer, at visit
4. History of clinician-diagnosed attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, epilepsy, major depressive disorder, mania or bipolar disorder, or any Diagnostic and Statistical Manual-V (DSM-V) psychotic disorder, such as schizophrenia
5. Evidence of substance abuse, including alcohol and nicotine, in the past 2 years
6. Systemic antihistamine or nicotine use Part A: within the week prior to the visit Part B: during the week prior to screening
7. Part B Only: Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline
8. Part B Only: At baseline, presence of any conditions listed as criteria for study drug discontinuation
9. Part B Only: Treatment with high potency or super-potent TCS within 14 days prior to baseline
Clareo Health | Neuropsychologic Assessments of Dupilumab-Treated Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
