- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06116526
Dupilumab De-escalation in Pediatric Atopic Dermatitis
Dupilumab De-escalation in Pediatric Atopic Dermatitis: A Pilot Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Hsing-Jou Su, MD
- Phone Number: 9292178030
- Email: hsu28@jh.edu
Study Contact Backup
- Name: Karin Kartawira, BA
- Phone Number: 667-290-4998
- Email: kkartaw1@jh.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21210
- Recruiting
- Johns Hopkins Univerisity
-
Contact:
- Hsing-Jou Su, MD
-
Contact:
- Karin Kartawira, BA
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 1 to <18 years old, either sex, any race or ethnicity
- Provide signed informed consent by parent or legal guardian and informed assent if applicable
- Has a physician confirmed diagnosis of atopic dermatitis
- Has received dupilumab for at least 12 months for the treatment of atopic dermatitis
- Has had well-controlled atopic dermatitis on dupilumab within last 6 months (defined as POEM<=7, EASI<=7, or IGA<=2)
- Able to speak English
- Able and willing to adhere to all study procedures
Exclusion Criteria:
- Taking concurrent systemic medication for atopic dermatitis (e.g., methotrexate, cyclosporine, tralokinumab, abrocitinib, upadacitinib, systemic corticosteroids)
- Using concurrent phototherapy for atopic dermatitis
- Taking dupilumab for a clinical indication other than atopic dermatitis (such as asthma or eosinophilic esophagitis)
- Poor control of atopic dermatitis
- Poor control of asthma or eosinophilic esophagitis
- Has used an investigational drug within 90 days or plan to use an investigational drug during the study period
- Does not have health insurance or will lose health insurance during the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dupilumab - discontinuation
Participants will discontinue their dupilumab treatment for atopic dermatitis.
|
Drug injections are discontinued.
Other Names:
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Experimental: Dupilumab - dose reduction
Participants whose standard dupilumab dosing for atopic dermatitis is 200 mg or 300 mg every 2 weeks will decrease drug administration to every 4 weeks, and participants whose standard dupilumab dosing is 200 mg or 300 mg every 4 weeks will decrease administration to every 8 weeks.
|
The drug is given as a subcutaneous injection.
Other Names:
|
Experimental: Dupilumab - standard dosing
Participants will continue to receive standard maintenance dupilumab dosing for atopic dermatitis according to FDA labeling, as indicated below. Infants ≥6 months and Children <6 years: 5 to <15 kg: 200 mg every 4 weeks. 15 to <30 kg: 300 mg every 4 weeks Children ≥6 years and Adolescents ≤17 years: 15 to <30 kg: 300 mg every 4 weeks 30 to <60 kg: 200 mg every other week ≥60 kg: 300 mg every other week |
The drug is given as a subcutaneous injection.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants with Successful Dose Reduction of Dupilumab
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
|
Successful de-escalation is defined as maintaining a reduced dose (i.e., less frequent administration) of dupilumab after initial de-escalation on week 0. Patients who require re-escalating the dose of dupilumab to standard dosing or adding other systemic treatments for their AD will be regarded as treatment failure.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Percentage of Participants with Successful Discontinuation of Dupilumab
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Successful discontinuation is defined as maintaining discontinuation of dupilumab after initial discontinuation on week 0. Patients who require resumption of dupilumab or beginning other systemic treatments for their AD will be regarded as treatment failure.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Investigator's Global Assessment (IGA) Scores
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
|
IGA is a global clinical assessment scale to determine severity of AD and clinical response to treatment on a static 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on the degree of erythema and papulation/infiltration.
The IGA score ranges from 0 to 4. Higher scores indicate greater severity of AD.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Change in Eczema Area and Severity Index (EASI) Scores
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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The EASI score is used to evaluate severity of AD based on AD clinical signs and % of body surface area (BSA) affected.
Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin] and lower limbs [including buttocks]) on 4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe.
The total EASI score ranges from 0 to 72.
Higher scores indicate greater severity of AD.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Change in Patient Oriented Eczema Measure (POEM) Scores
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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The POEM is a 7-item questionnaire to assess disease symptoms in children and adults with AD.
It is composed of 7 items (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) based on symptom frequency during the past week (0 = 'no days', 1 = '1 to 2 days', 2 = '3 to 4 days', 3 = '5 to 6' days, and 4 = 'every day').
The total POEM score ranges from 0 to 28.
Higher scores indicate more severe disease and poor quality of life.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Itch questionnaire score
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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The PROMIS Itch questionnaire measures the extent to which patients experience problems with itchiness over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; and 5 = Almost Always).
Higher scores reflect greater severity of experienced itch symptoms.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Problem questionnaire score
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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The PROMIS Sleep Problem questionnaire measures the extent to which patients experience problems with sleep over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Almost always; and 5 = Always).
The sleep problems contain sleep disturbances (sleep quality, sleep onset, sleep continuity) and sleep-related impairment (perceptions of sleepiness during usual awake hours and reported impairments during the day associated with sleep problems or daytime sleepiness).
Higher scores reflect greater severity of sleep problems.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety questionnaire score
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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The PROMIS Anxiety questionnaire measures the extent to which patients experience problems with anxiety over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Often; and 5 = Almost Always).
The questionnaire includes fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), social/separation anxiety (fear or distress when separating from caregivers), and somatic symptoms related to arousal (racing heart, dizziness).
Higher scores reflect greater severity of experienced anxiety symptoms.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms questionnaire score
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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The PROMIS Depressive Symptoms questionnaire measures the extent to which patients experience problems with depression over the past 7 days using a 5-point Likert scale (1 = Never; 2 = Almost never; 3 = Sometimes; 4 = Almost Always; and 5 = Always).
The depressive symptoms include negative mood (sadness, guilt), views of self (self-criticism, worthlessness), and social cognition (loneliness, interpersonal alienation); decreased positive affect, anhedonia (loss of interest, inability to engage in play), and engagement.
Higher scores reflect greater severity of experienced depressive symptoms.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Function questionnaire score
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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The PROMIS Cognitive Function questionnaire measures the extent to which patients experience problems with cognitive function over the past 4 weeks using a 5-point Likert scale (1 = All of the time; 2 = Most of the time; 3 = Some of the time; 4 = A little of the time; and 5 = None of the time).
The questionnaire includes difficulties in cognitive abilities (e.g., memory, attention, and decision making), and difficulties in the application of such abilities to everyday tasks (e.g., planning, organizing, calculating, remembering, and learning).
Lower scores reflect greater impact on cognitive function.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health questionnaire score
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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The PROMIS Global Health questionnaire measures the extent to which patients experience problems with global health in general using a 5-point Likert scale (1 = Poor; 2 = Fair; 3 = Good; 4 = Fair; and 5 = Excellent).
The questionnaire includes an overall evaluation of physical, mental health, and social health.
Higher scores reflect a lower quality of global health.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity questionnaire score
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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The PROMIS Pain Intensity questionnaire measures the intensity of patients' pain due to their AD over the past 7 days using a 10 point scale, with 0 indicating "No Pain" and 10 indicating "the worst pain possible."
Higher raw scores reflect greater severity of experienced pain due to AD.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Change in Children's Dermatology Life Quality Index (CDLQI) score
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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CDLQI is a 10-item questionnaire to assess the impact of skin problems on the quality of life of children between the ages of 4-16 years old over the last one week.
Each question is evaluated on a 4-point scale: Not at all = 0, A Little = 1, Quite A Lot = 2, Very Much = 3.
Higher scores indicate worse child-reported quality of life.
CDLQI scores indicate the degree of severity burden on the quality of life: No effect = 0-1; Small effect = 2-6; Moderate effect = 7-12; Very large effect = 13-18; and Extremely large effect = 19-30.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Change in Family Dermatology Life Quality Index (FDLQI) score
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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FDLQI is a 10-item questionnaire to assess the impact of skin problems on the quality of life of families over the last one month.
Each question is evaluated on a 4-point scale: Not at all = 0, A Little = 1, Quite A Lot = 2, Very Much = 3.
Higher scores indicate worse quality of life.
FDLQI scores indicate the degree of severity burden on the quality of life: No effect = 0-1; Small effect = 2-6; Moderate effect = 7-12; Very large effect = 13-18; and Extremely large effect = 19-30.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Changes in Utilization of Topical Medications for Atopic Dermatitis
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Participants will provide a self-report of their daily utilization of topical medications (medication name, dose and frequency) using a paper-form Daily Diary.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Adverse Events After Dupilumab Dose-reduction or Discontinuation
Time Frame: From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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The number of participants who experience adverse events ≥ Grade 2 is based on the Common Terminology Criteria for Adverse Events (CTCAE).
The CTCAE is generally graded as follows: Grade 1 - mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not needed; Grade 2 - moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living; Grade 3 - severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self care activities of daily living; Grade 4 - life-threatening consequences; urgent intervention indicated; Grade 5 - death related to adverse event.
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From Baseline through Week 16 (active protocol phase) and Week 17 through Week 52 (observational phase)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joy Wan, MD MSCE, Johns Hopkins University
Publications and helpful links
General Publications
- Langan SM, Irvine AD, Weidinger S. Atopic dermatitis. Lancet. 2020 Aug 1;396(10247):345-360. doi: 10.1016/S0140-6736(20)31286-1. Erratum In: Lancet. 2020 Sep 12;396(10253):758.
- Drucker AM, Wang AR, Li WQ, Sevetson E, Block JK, Qureshi AA. The Burden of Atopic Dermatitis: Summary of a Report for the National Eczema Association. J Invest Dermatol. 2017 Jan;137(1):26-30. doi: 10.1016/j.jid.2016.07.012. Epub 2016 Sep 8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00405441
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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