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)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Dermatitis, Atopic

Treatments: Other: Background Treatment: Moisturizers; Other: Background Treatment: Topical Corticosteroids; Drug: Matching Placebo; Drug: Dupilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03345914

R668-AD-1652

2016-004997-16 (EudraCT Number)

Details and patient eligibility

About

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 atopic dermatitis (AD).

The secondary objective is to assess the safety of dupilumab administered concomitantly with TCS in patients ≥6 years to <12 years of age with severe AD.

Enrollment: 367 patients

Sex: All

Ages: 6 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Diagnosis of AD according to the American Academy of Dermatology consensus criteria (Eichenfield 2003) at screening visit
2. Chronic AD diagnosed at least 1 year prior to the screening visit
3. IGA = 4 at screening and baseline visits
4. EASI ≥21 at the screening and baseline visits
5. BSA ≥15% at screening and baseline visits
6. Documented recent history (within 6 months before the baseline visit) of inadequate response to topical AD medication(s)
7. 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 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 (e.g, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or patient's treating physician

6. Treatment with a topical calcineurin inhibitor (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:

   1. Immunosuppressive/immunomodulating drugs (e.g, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
   2. Phototherapy for AD

8. Treatment with biologics, as follows:

   1. 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

   2. 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

Note: Other Inclusion/ Exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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367 participants in 3 patient groups

Group 1

Experimental group

Description:

Participants will receive dupilumab, dosing regimen 1

Treatment:

Other: Background Treatment: Topical Corticosteroids

Drug: Dupilumab

Other: Background Treatment: Moisturizers

Group 2

Experimental group

Description:

Participants will receive dupilumab, dosing regimen 2

Treatment:

Other: Background Treatment: Topical Corticosteroids

Drug: Dupilumab

Other: Background Treatment: Moisturizers

Group 3

Experimental group

Description:

Participants will receive matching placebo

Treatment:

Other: Background Treatment: Topical Corticosteroids

Other: Background Treatment: Moisturizers

Drug: Matching Placebo