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Moderate-to-severe Atopic DermatitisNEURADADNCT05203380

Neuropsychologic Assessments of Dupilumab-Treated Adolescent Participants With Moderate-to-Severe Atopic Dermatitis

An observational study of Moderate-to-severe Atopic Dermatitis, run by Regeneron Pharmaceuticals at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Primary Objective: Part A To quantify deficits in cognitive functioning in adolescents with moderate-to-severe AD, using the Conners' Continuous Performance Test 3rd Edition (CPT-3) d' T-score To determine the entry criterion (CPT-3 d' score) for Part B Primary Objective: Part B To measure changes in cognitive… Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Moderate-to-severe Atopic Dermatitis
What is being tested?
dupilumab
How many people
45 participants
Where
10 sitesUnited States
Study dates
27 Jan 2022to 10 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Adolescents with moderate-to-severe atopic dermatitis (AD) will be assessed for quantifying deficits in cognitive functioning at a single visit only and no study-related treatment will be offered.

Who may be able to join

  • Adolescent (12 - 17 years of age) Part A: at time of visit Part B: at time of screening visit
  • 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
  • EASI score ≥ 12 Part A: at time of visit Part B: at screening and baseline visits
  • IGA score ≥ 3 Part A: at time of visit Part B: at time of screening and baseline visits
  • 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
  • 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
Show all 9Show fewer
  • BSA of AD involvement ≥ 10% Part A: at time visit Part B: at screening and baseline visits
  • 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
  • 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

Who cannot join

  • Prior use of dupilumab Part A: within 6 months of visit Part B: within 6 months of screening
  • Skin diseases that could confound AD assessment as defined in the protocol
  • 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
  • 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
  • Evidence of substance abuse, including alcohol and nicotine, in the past 2 years
  • Systemic antihistamine or nicotine use Part A: within the week prior to the visit Part B: during the week prior to screening
Show all 10Show fewer
  • 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
  • Part B Only: At baseline, presence of any conditions listed as criteria for study drug discontinuation
  • Part B Only: Treatment with high potency or super-potent TCS within 14 days prior to baseline
  • NOTE: Other protocol defined inclusion/exclusion criteria apply

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Clinical Research Center of Alabama, LLC

    Birmingham, Alabama, 35209

  • Ann & Robert H. Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611

  • Pediatric Skin Research, LLC

    Coral Gables, Florida, 33146

  • Arizona Allergy & Immunology Research

    Gilbert, Arizona, 85234

  • Skin Care Physicians of Georgia

    Macon, Georgia, 31217

  • Skin Research of South Florida, LLC

    Miami, Florida, 33173

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia, 23502

  • National Allergy and Asthma Research, LLC

    North Charleston, South Carolina, 29420

  • DermAssociates, LLC

    Rockville, Maryland, 20850

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218

Other trials in United States

About this study

Official title: Neuropsychologic Assessments of Dupilumab-Treated Adolescents With Moderate-to-Severe Atopic Dermatitis

Primary Objective: Part A

  • To quantify deficits in cognitive functioning in adolescents with moderate-to-severe AD, using the Conners' Continuous Performance Test 3rd Edition (CPT-3) d' T-score
  • To determine the entry criterion (CPT-3 d' score) for Part B

Primary Objective: Part B

  • To measure changes in cognitive functioning in adolescents with moderate-to-severe AD treated with dupilumab

Secondary Objectives

  • To evaluate the relationship of cognitive and sensory functioning with severity of AD in adolescent AD patients
  • To evaluate the relationship between changes in AD severity and changes in cognitive and sensory functioning scores following treatment with dupilumab (Part B only).
Read the detailed description

Per protocol Study Stop Criteria, study has concluded with Part A. Part B was not initiated and no data were collected.

Being tested
dupilumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dupilumabDrug

    Also called DUPIXENT®

    Weight based dosing for 16 weeks in accordance of United States prescribing information (USPI)

Study groups in NCT05203380
Study groupRoleWhat they receive
Part AAssessed in a single visit and no study-related treatment will be given.
Part BPatients in Part A may also enroll in Part B provided they meet the eligibility criteria.
Receives: Drug: dupilumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of AD patients with a Conner's CPT-3 d' T-score ≥ 60

    Part A

    Conners' Continuous Performance Test-3 (CPT-3): an objective test of attention and impulsivity that has been validated in individuals aged 8 years and older. The primary efficacy outcome measure (d' T-score) is a measure of "signal detectability" with respect to inattentiveness, that is, the respondent's ability to differentiate non-targets (ie, the letter X) from targets (ie, all other letters), and is calculated as: d' = z-score ("False Alarm") - z-score ("Hit"). "T scores" refer to a distribution of the d' statistic such that the mean is 50 and the standard deviation (SD) is 10. Lower d' T-score values indicate worse performance.

    Measured: Day 1

  2. Mean change from baseline in Conner's CPT-3 d' T-score

    Part B

    Conner's CPT-3 d' T-scoring as stated above.

    Measured: At week 16

Secondary outcomes (41)

  1. Correlation of values for Conners' Continuous Performance Test 3rd Edition (CPT-3) scores (d' T-score, Commission Errors, Omission Errors, and Reaction Time) with AD disease severity based on Eczema Area and Severity Index (EASI)

    Part A

    Conner's CPT-3 d' T-scoring as stated above.

    EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. Four AD disease characteristics (erythema, thickness [induration, apulation, edema], scratching [excoriation], and lichenification) will each be assessed for severity by the investigator or designee on a scale of 0" (absent) through "3" (severe). In addition, the area of AD involvement will be assessed as a percentage by body area of head, trunk, upper limbs, and lower limbs, and converted to a score of 0 to 6.

    Measured: Day 1

  2. Correlation of values for Conners' CPT-3 scores with AD disease severity based on Body Surface Area (BSA)

    Part A

    Conner's CPT-3 d' T-scoring as stated above.

    BSA affected by AD is assessed for each section of the body using the rule of nines (the possible highest score for each region is: head and neck [9%], anterior trunk [18%], back [18%], upper limbs [18%], lower limbs [36%], and genitals [1%]) and will be reported as a percentage of all major body sections combined.

    Measured: Day 1

  3. Correlation of values for Conners' CPT-3 scores with AD disease severity based on Peak Pruritus Numeric Rating Scale (NRS)

    Part A

    Conner's CPT-3 d' T-scoring as stated above.

    Peak Pruritus NRS is a simple assessment tool that patients will use to report the average intensity of their pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).

    Measured: Day 1

  4. Correlation of values for Conners' CPT-3 scores with AD disease severity based on Skin Pain Numeric Rating Scale (SP-NRS)

    Part A

    Conner's CPT-3 d' T-scoring as stated above.

    SP-NRS is a validated, self-administered PRO measuring the skin pain severity at its worst with a recall period of 24 hours pain severity in adults and adolescents. This single-item questionnaire uses an 11-point scale, which ranges from "0-No pain" to "10-Worst pain possible." Skin pain severity based on SP-NRS can be categorized as: clear (0), mild (1-3), moderate (5-6), severe (7-9), and very severe (10).

    Measured: Day 1

  5. Correlation of values for Conners' CPT-3 scores with AD disease severity based on Patient-Reported Outcomes Measurement Information System Pediatric Sleep Disturbance Questionnaire (PROMIS Pediatric Sleep Disturbance)

    Part A

    Conner's CPT-3 d' T-scoring as stated above.

    PROMIS sleep disturbance questionnaire is used to measure self-reported perceptions of sleep quality, sleep depth, and restoration. This includes perceived difficulties getting to sleep and staying asleep, as well as sleep satisfaction. Parent-reported sleep.

    Measured: Day 1

  6. Correlation of values for Conners' CPT-3 scores with AD disease severity based on Children's Dermatology Life Quality Index (CDLQI)

    Part A

    Conner's CPT-3 d' T-scoring as stated above.

    CDLQI is a validated questionnaire designed to measure the impact of skin disease on the quality of life (QoL) in children over a recall period of the past week. 9 of the 10 questions are scored by (0) Not answered/not at all, (1) only a little, (2) quite a lot to (3) very much. Question 7 has a possible response of (3) prevented school. The sum of the score of each question has a maximum of 30 and a minimum of 0. The higher the score the greater the impact on QoL. CDLQI can be a percentage of the maximum possible score of 30.

    Measured: Day 1

  7. Correlation of values for Conners' CPT-3 scores with AD disease severity based on Hospital Anxiety and Depression Scale (HADS)

    Part A

    Conner's CPT-3 d' T-scoring as stated above.

    HADS is an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes in a patient's emotional state. HADS consists of 14 items, 7 each for anxiety and depression symptoms; possible scores range from 0 to 21 for each subscale. The following cut-off scores are recommended for both subscales: 7 to 8 for possible presence, 10 to 11 for probable presence, and 14 to 15 for severe anxiety or depression.

    Measured: Day 1

  8. Correlation of values for Conners' CPT-3 scores with AD disease severity based on Investigator's Global Assessment (IGA)

    Part A

    Conner's CPT-3 d' T-scoring as stated above.

    IGA is an instrument used for rapid and easy assessment of atopic dermatitis disease lesional severity globally based on a 5-point scale with range from 0-4, (0 = Clear, 1 = Almost clear, 2 = Mild disease, 3 = Moderate disease and 4 = Severe disease).

    Measured: Day 1

  9. Correlation of values for Adult/Adolescent Sensory Profile (AASP) Sensory Sensitivity Score with AD disease severity based on EASI

    Part A

    AASP is a 60-item self-report questionnaire measuring sensory responsiveness patterns in six different sensory modalities, including taste/smell, movement, visual, touch, activity and auditory processing. Patients complete the AASP by responding to each item with a five-point Likert scale (1 = almost never, 2 = seldom, 3 =occasionally, 4 = frequently, or 5 = always). Higher scores in each quadrant represented stronger preference to adopt certain types of sensory responsiveness patterns. The quadrant score can be categorized into one of the 5 categories, indicating how a particular patient's score compares to people in the same age group (adolescents of age 11-17 years) without disabilities: much less than most people, less than most people, similar to most people, more than most people, much more than most people.

    EASI measuring as stated above.

    Measured: Day 1

  10. Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on BSA

    Part A

    AASP scoring as stated above. BSA scoring as stated above.

    Measured: Day 1

  11. Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on Peak Pruritus NRS

    Part A

    AASP scoring as stated above. Peak Pruritus NRS scaling as stated above.

    Measured: Day 1

  12. Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on SP-NRS

    Part A

    AASP scoring as stated above. SP-NRS scaling as stated above.

    Measured: Day 1

  13. Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on PROMIS Pediatric Sleep Disturbance Questionnaire

    Part A

    AASP scoring as stated above. PROMIS Pediatric sleep disturbance scaling as stated above.

    Measured: Day 1

  14. Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on CDLQI

    Part A

    AASP scoring as stated above. CDLQI scoring as stated above.

    Measured: Day 1

  15. Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on HADS

    Part A

    AASP scoring as stated above. HADS scoring as stated above.

    Measured: Day 1

  16. Correlation of values for AASP Sensory Sensitivity Score with AD disease severity based on IGA

    Part A

    AASP scoring as stated above. IGA scoring as stated above.

    Measured: Day 1

  17. Correlation of values for Stroop Interference Score with AD disease severity based on EASI

    Part A

    Stroop Color and Word Test (SCWT) is a test used to measure selective inhibition, the ability to attend to certain environmental stimuli while inhibiting other stimuli. Stroop Interference scores are calculated from the number of correctly identified items in the three trials. Higher Stroop Interference scores represent poorer performance and suggests impaired executive functioning.

    EASI scoring as stated above.

    Measured: Day 1

  18. Correlation of values for SCWT Interference Score with AD disease severity based on BSA

    Part A

    SCWT scoring as stated above. BSA scoring as stated above.

    Measured: Day 1

  19. Correlation of values for Stroop Interference Score with AD disease severity based on Peak Pruritus NRS

    PART A

    SCWT scoring as stated above. Peak Pruritus NRS scoring as stated above.

    Measured: Day 1

  20. Correlation of values for Stroop Interference Score with AD disease severity based on SP-NRS

    Part A

    SCWT scoring as stated above. SP-NRS scoring as stated above.

    Measured: Day 1

  21. Correlation of values for Stroop Interference Score with AD disease severity based on PROMIS Pediatric Sleep Disturbance Questionnaire

    Part A

    SCWT scoring as stated above. PROMIS scoring as stated above.

    Measured: Day 1

  22. Correlation of values for Stroop Interference Score with AD disease severity based on CDLQI

    Part A

    SCWT scoring as stated above. CDLQI scoring as stated above.

    Measured: Day 1

  23. Correlation of values for Stroop Interference Score with AD disease severity based on HADS

    Part A

    SCWT scoring as stated above. HADS scoring as stated above.

    Measured: Day 1

  24. Correlation of values for Stroop Interference Score with AD disease severity based on IGA

    Part A

    SCWT scoring as stated above. IGA scoring as stated above.

    Measured: Day 1

  25. Determine the appropriate minimal Conners' CPT-3 d-prime T score

    Used as an entrance criterion into Part B

    Measured: Day 1

  26. Correlation of change in AD disease severity based on EASI with change in Conners' CPT-3 score

    Part B

    EASI scoring as stated above. Conners' CPT-3 scoring as stated above.

    Measured: Up to Week 16

  27. Correlation of change in AD disease severity based on BSA with change in Conners' CPT-3 score

    Part B

    BSA scoring as stated above. Conners' CPT-3 scoring as stated above.

    Measured: Up to Week 16

  28. Correlation of change in AD disease severity based on Peak Pruritus NRS with change in Conners' CPT-3 score

    Part B

    Peak Pruritus NRS scoring as stated above. Conners' CPT-3 scroring as stated above.

    Measured: Up to Week 16

  29. Correlation of change in AD disease severity based on SP-NRS with change in Conners' CPT-3 score

    Part B

    SP-NRS scoring as stated above. Conners' CPT-3 scoring as stated above.

    Measured: Up to Week 16

  30. Correlation of change in AD disease severity based on PROMIS Pediatric Sleep Disturbance with change in Conners' CPT-3 score

    Part B

    PROMIS scoring as stated above. Conners' CPT-3 scoring as stated above.

    Measured: Up to Week 16

  31. Correlation of change in AD disease severity based on CDLQI with change in Conners' CPT-3 score

    Part B

    CDLQI scoring as stated above. Conners' CPT-3 scoring as stated above.

    Measured: Up to Week 16

  32. Correlation of change in AD disease severity based on HADS with change in Conners' CPT-3 score

    Part B

    HADS scoring as stated above. Conners' CPT-3 scoring as stated above.

    Measured: Up to Week 16

  33. Correlation of change in AD disease severity based on IGA with change in Conners' CPT-3 score

    Part B

    IGA scoring as stated above. Conners' CPT-3 scoring as stated above.

    Measured: Up to Week 16

  34. Correlation of change in AD disease severity based on EASI with AASP Sensory Sensitivity Summary Score

    Part B

    EASI scoring as stated above. AASP scoring as stated above.

    Measured: Up to Week 16

  35. Correlation of change in AD disease severity based on BSA with AASP Sensory Sensitivity Summary Score

    Part B

    BSA scoring as stated above. AASP scoring as stated above.

    Measured: Up to Week 16

  36. Correlation of change in AD disease severity based on Peak Pruritus NRS with AASP Sensory Sensitivity Summary Score

    Part B

    Peak Pruritus NRS scoring as stated above. AASP scoring as stated above.

    Measured: Up to Week 16

  37. Correlation of change in AD disease severity based on SP-NRS with AASP Sensory Sensitivity Summary Score

    Part B

    SP-NRS scoring as stated above. AASP scoring as stated above.

    Measured: Up to Week 16

  38. Correlation of change in AD disease severity based on PROMIS Pediatric Sleep Disturbance with AASP Sensory Sensitivity Summary Score

    Part B

    PROMIS scoring as stated above. AASP scoring as stated above.

    Measured: Up to Week 16

  39. Correlation of change in AD disease severity based on CDLQI with AASP Sensory Sensitivity Summary Score

    Part B

    CDLQI scoring as stated above. AASP scoring as stated above.

    Measured: Up to Week 16

  40. Correlation of change in AD disease severity based on HADS with AASP Sensory Sensitivity Summary Score

    Part B

    HADS scoring as stated above. AASP scoring as stated above.

    Measured: Up to Week 16

  41. Correlation of change in AD disease severity based on IGA with AASP Sensory Sensitivity Summary Score

    Part B

    IGA scoring as stated above. AASP scoring as stated above.

    Measured: Up to Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start27 Jan 2022
  3. Primary completion10 Mar 2023
  4. Study completion10 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05203380
Sponsor's protocol ID
R668-AD-2024
Acronym
NEURADAD
Status last verified
Aug 2023
First submitted
5 Jan 2022
Last updated
8 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Paller AS, Gonzalez ME, Barnum S, Jaeger J, Shao L, Ozturk ZE, Korotzer A. Attentiveness and mental health in adolescents with moderate-to-severe atopic dermatitis without ADHD. Arch Dermatol Res. 2024 Jul 30;316(8):497. doi: 10.1007/s00403-024-03210-x.

    PubMed 39080094

Questions about this trial

What is this clinical trial studying?

An observational study of Moderate-to-severe Atopic Dermatitis, run by Regeneron Pharmaceuticals at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of AD patients with a Conner's CPT-3 d' T-score ≥ 60 (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05203380, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2023.

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