Status:
COMPLETED
Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Sanofi
Conditions:
Dermatitis, Atopic
Eligibility:
All Genders
6-11 years
Phase:
PHASE3
Brief Summary
The main objective of the trial is to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in participants ≥6 years to \<12 years of age with severe atop...
Eligibility Criteria
Inclusion
- Key
- Diagnosis of AD according to the American Academy of Dermatology consensus criteria (Eichenfield 2003) at screening visit
- Chronic AD diagnosed at least 1 year prior to the screening visit
- IGA = 4 at screening and baseline visits
- EASI ≥21 at the screening and baseline visits
- BSA ≥15% at screening and baseline visits
- 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 during the 7 consecutive days immediately before the baseline visit
- Key
Exclusion
- Participation in a prior dupilumab clinical study
- Treatment with a systemic investigational drug before the baseline visit
- Treatment with a topical investigational drug within 2 weeks prior to the baseline visit
- Treatment with crisabarole within 2 weeks prior to the baseline visit
- History of important side effects of medium potency topical corticosteroids (e.g, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or patient's treating physician
- Treatment with a topical calcineurin inhibitor (TCI) within 2 weeks prior to the baseline visit
- Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:
- Immunosuppressive/immunomodulating drugs (e.g, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy for AD
- Treatment with biologics, as follows:
- Any cell-depleting agents including but not limited to rituximab:
- within 6 months before the baseline visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer
- Other biologics: within 5 half-lives (if known) or 16 weeks before the baseline visit, whichever is longer
- Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
- Body weight \<15 kg at baseline
- Note: Other Inclusion/ Exclusion criteria apply
Key Trial Info
Start Date :
November 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 10 2019
Estimated Enrollment :
367 Patients enrolled
Trial Details
Trial ID
NCT03345914
Start Date
November 17 2017
End Date
September 10 2019
Last Update
August 13 2020
Active Locations (61)
Enter a location and click search to find clinical trials sorted by distance.
1
Regeneron Research Site
Birmingham, Alabama, United States, 35209
2
Regeneron Research Site
Gilbert, Arizona, United States, 85234
3
Regeneron Research Site
Bakersfield, California, United States, 93309
4
Regeneron Research Site
Long Beach, California, United States, 90808