A randomized study to investigate the efficacy and safety of dupilumab administered with topical corticosteroids in patients =6 to <12 years with severe atopic dermatitis

Phase 1

• Conditions: Atopic Dermatitis; MedDRA version: 20.0 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2016-004997-16-CZ
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-03
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 330

Inclusion Criteria

1. Male or female =6 to <12 years of age at time of screening visit
2. Diagnosis of AD according to the American Academy of Dermatology consensus criteria (Eichenfield 2003) at screening visit
3. Chronic AD diagnosed at least 1 year prior to the screening visit
4. IGA = 4 at screening and baseline visits
5. EASI =21 at the screening and baseline visits
6. BSA =15% at screening and baseline visits
7. Documented recent history (within 6 months before the baseline visit) of inadequate response to topical AD medication(s)
8. 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

Are the trial subjects under 18? yes
Number of subjects for this age range: 330
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;<br> Primary end point(s): 1. Proportion of patients with EASI-75 (=75% improvement from baseline) at week 16<br> 2. Proportion of patients with IGA 0 or 1 (on a 5-point scale) at week 16<br> <br> <br> ;<br> Timepoint(s) of evaluation of this end point: Ad 1: at week 16<br> Ad 2: at week 16<br>