Status:
COMPLETED
Dupilumab in Japanese Patients With Atopic Dermatitis
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
6-17 years
Phase:
PHASE3
Brief Summary
Primary Objective: To evaluate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) Secondary Objective: To evaluate the efficacy of dupilumab administered concom...
Detailed Description
For participant who declines to enter open-lebal extension (OLE), the duration of the study for each participant is approximately 33 weeks (including screening and follow-up) For participant choosing ...
Eligibility Criteria
Inclusion
- Inclusion criteria :
- Japanese and ≥6 months to \<18 years of age, at the time of signing the informed consent and/or assent.
- Diagnosis of AD according to the American Academy of Dermatology consensus criteria at screening visit.
- Chronic AD diagnosed at least 1 year prior to the screening visit (for participants between 6 months to \<1 year of age, the requirement is to have had chronic AD for 3 months).
- (Investigator's Global Assessment) IGA ≥ 3 at screening and baseline visits. (Eczema Area and Severity Index) EASI ≥16 at screening and baseline visits. Baseline peak pruritus Numerical Rating Scale (NRS) average score for maximum itch intensity ≥4 for participants ≥12 to \<18 years of age.
- Baseline worst itch NRS or worst scratch/itch NRS weekly average score for maximum itch or scratch/itch intensity ≥4 for participants ≥6 months to \<12 years of age.
- Body surface area (BSA) of AD involvement \>10% at screening and baseline visits.
- With documented recent history (within 6 months before the baseline visit) of inadequate response to topical AD medication(s).
- At least 11 (of a total of 14) applications of a stable dose of topical emollient (moisturizer) twice daily immediately before the baseline visit.
- Willing and able to comply with all clinic visits and study-related procedures. Participant, either alone or with help of parents/legal guardians (for 6 years old to less than18 years of age) or parents/caregiver or legal guardians (for 6 months to less than 6 years of age) as appropriate, must be able to understand and complete study-related questionnaires.
- Body weight ≥5 kg at baseline. Contraceptive use by female participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Exclusion criteria:
- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit or during the screening period.
- Known or suspected immunodeficiency, including history of invasive opportunistic infections Participants with active tuberculosis (TB) or non-tuberculous mycobacterial infection, or a history of incompletely treated TB will be excluded from the study unless it is well documented by a specialist that the participant has been adequately treated and can now start treatment with a biologic agent, in the medical judgment of the Investigator and/or infectious disease specialist.
- Known history of human immunodeficiency virus (HIV)-1 and HIV-2 infection or HIV seropositivity at the screening
- Participants with any of the following result at the screening:
- Positive (or indeterminate) Hepatitis B surface antigen (HBs Ag) or,
- Positive hepatitis B core antibody (HBc Ab) confirmed by positive hepatitis B virus (HBV) DNA or,
- Positive hepatitis C antibody (HCV Ab) confirmed by positive hepatitis C virus (HCV) RNA.
- Presence of skin comorbidities that may interfere with study assessments History of malignancy within 5 years before the baseline visit History of systemic hypersensitivity or anaphylaxis to dupilumab or any other biologic therapy.
- Known or suspected alcohol and/or drug abuse. Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection.
- Severe concomitant illness(es) that, in the Investigator's judgment, would adversely affect the participant's participation in the study.
- Participant with any other medical or psychological condition including relevant laboratory or electrocardiogram (ECG) abnormalities at screening Exposure to another systemic or topical investigative drug within a certain time period prior to Visit 1 (screening), Having used any of immunosuppressive/immunomodulating drugs and phototherapy within 4 weeks before the screening visit.
- Past Treatment with biologics as follows:
- Any cell-depleting agents within 6 months before the screening visit.
- Anti-IgE therapy within 4 months before the screening visit.
- Other monoclonal antibodies (which are biological response modifiers): within 5 half-lives (if known) or 16 weeks before the screening visit (Visit 1), whichever is longer.
- History of important side effects to medium potency TCS Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit.
- Either intravenous immunoglobulin therapy and/or plasmapheresis within 30 days prior to screening visit.
- Planned or anticipated use of any prohibited medications and procedures during screening and study treatment period.
- Initiation of treatment of AD with prescription moisturizers or moisturizers containing additives such as ceramide, hyaluronic acid, urea, or filaggrin degradation products during the screening period Participation in a prior dupilumab clinical study or have been treated with commercially available dupilumab.
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Exclusion
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2023
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04678882
Start Date
January 15 2021
End Date
October 28 2023
Last Update
September 12 2025
Active Locations (19)
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1
Investigational Site Number : 3920011
Nagoya, Aichi-ken, Japan, 457-8510
2
Investigational Site Number : 3920014
Toyoake-shi, Aichi-ken, Japan, 470-1192
3
Investigational Site Number : 3920015
Fukutsu-shi, Fukuoka, Japan, 811-3217
4
Investigational Site Number : 3920001
Hiroshima, Hiroshima, Japan, 734-8551