Atopic Dermatitis MedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858
Conditions
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female =6 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Participation in a prior dupilumab clinical study 2. Treatment with a systemic investigational drug before the baseline visit 3. Treatment with a topical investigational drug within 2 weeks prior to the baseline visit 4. Treatment with crisabarole within 2 weeks prior to the baseline visit 5. History of important side effects of medium potency topical corticosteroids (eg, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or patient’s treating physician 6. Treatment with a TCI within 2 weeks prior to the baseline visit 7. 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: a. Immunosuppressive/immunomodulating drugs (eg, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors, azathioprine, methotrexate, etc.) b. Phototherapy for AD 8. Treatment with biologics, as follows: a. 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 b. Other biologics: within 5 half-lives (if known) or 16 weeks before the baseline visit, whichever is longer 9. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit 10. Body weight <15 kg at baseline 11. 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 (patients may continue using stable doses of such moisturizers if initiated before the screening visit) 12. Regular use (more than 2 visits per week) of a tanning booth/parlor within 8 weeks of the baseline visit 13. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit 14. Established diagnosis of a primary immunodeficiency disorder 15. History of past or current tuberculosis or other mycobacterial infection 16. Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit 17. Established diagnosis of hepatitis B viral infection at the time of screening or is positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) at the time of screening 18. Established diagnosis of hepatitis C viral infection at the time of screening or is positive for hepatitis C antibody at the screening visit 19. On current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis, or hepatic failure, or has evidence of liver disease as indicated by persistent (confirmed by repeated tests =2 weeks apart) elevated transaminases (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]) more than 3 times the upper limit of normal (ULN) during the scre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in patients =6 years to <12 years of age with severe atopic dermatitis (AD).;Secondary Objective: To assess the safety of dupilumab administered concomitantly with TCS in patients =6 years to <12 years of age with severe AD.; Primary end point(s): 1. Proportion of patients with EASI-75 (=75% improvement from baseline) at week 16 2. Proportion of patients with IGA 0 or 1 (on a 5-point scale) at week 16 ; Timepoint(s) of evaluation of this end point: Ad 1: at week 16 Ad 2: at week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints 1. Percent change in EASI score from baseline to week 16 2. Percent change from baseline to week 16 in weekly average of daily worst itch score Other secondary endpoints: 1. Change from baseline to week 16 in weekly average of daily worst itch score 2. Proportion of patients with EASI-50 at week 16 3. Proportion of patients with EASI-90 at week 16 4. Change from baseline to week 16 in percent Body Surface Area (BSA) affected by AD 5. Percent change from baseline to week 16 in SCORing AD (SCORAD) 6. Proportion of patients with improvement (reduction) of weekly average of daily worst itch score =4 from baseline at week 16 7. Proportion of patients with improvement (reduction) of weekly average of daily worst itch score =3 from baseline at week 16 8. Time to onset of effect on pruritus during the 16-week treatment period (=4 point reduction of weekly average of daily worst itch score from baseline) 9. Time to onset of effect on pruritus during the 16-week treatment period (=3 point reduction of weekly average of daily worst itch score from baseline) 10. Change from baseline to week 16 in Children’s Dermatology Life Quality Index (CDLQI) 11. Change from baseline to week 16 in Patient Oriented Eczema Measure (POEM) 12. Change from baseline to week 16 in Dermatitis Family Index (DFI) 13. Change from baseline to week 16 in Patient-Reported Outcomes Measurement Information System (PROMIS) pediatric anxiety short form scale score 14. Change from baseline to week 16 in PROMIS pediatric depressive symptoms short form scale score 15. Topical treatment for AD – proportion of TCS medication-free days from baseline to week 16 | — |
Countries
Canada, Czech Republic, Germany, Poland, United Kingdom, United States
Contacts
Public ContactClinical Trial Information
Regeneron Pharmaceuticals, Inc.
Outcome results
None listed