A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Atopic Dermatitis

Treatments: Drug: Dupilumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02407756

R668-AD-1412

Details and patient eligibility

About

The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age).

The secondary objective of the study is to explore the immunogenicity and efficacy of dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age).

Enrollment: 78 patients

Sex: All

Ages: 6 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

1. Male or female patients ≥6 to <18 years of age with a diagnosis of 1. Atopic Dermatitis whose disease cannot be adequately controlled with topical medications

2. Minimum disease severity, as defined by Investigator's Global Assessment (IGA)

   1. IGA = 3 or 4 in adolescents ≥12 to <18 year of age
   2. IGA = 4 in children ≥6 to <12 years of age

Key Exclusion Criteria:

1. Recent treatment (within specific time windows before the baseline visit) with systemic immunosuppressive agents for eg. Systemic corticosteroids, live (attenuated) vaccines and other investigational drugs including biologics

2. History of any of the following infections:

   1. Any systemic infection requiring treatment within 4 weeks before the baseline visit
   2. Superficial skin infections within 1 week before the baseline visit
   3. Known history of HIV infection
   4. History of seropositivity to hepatitis B or C screening tests
   5. History of clinical endoparasitosis (ie, helminthic infection) within 12 months before the baseline visit, or high risk of helminthic infection, unless subsequent medical assessments (e.g. stool exam, blood tests, etc.) have ruled out the possibility of parasite infection/infestation

3. History of malignancy within 5 years before the baseline visit

4. 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 screening period

5. Presence of any severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study

6. Presence of skin comorbidities that may interfere with study assessments

7. Females patients who are pregnant or breastfeeding

8. Female patients who are of reproductive potential and are sexually active, who are unwilling to use adequate methods of contraception

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 2 patient groups

Cohort 1

Experimental group

Description:

Cohort 1 will receive dupilumab dosing regimen 1

Treatment:

Drug: Dupilumab

Cohort 2

Experimental group

Description:

Cohort 2 will receive dupilumab dosing regimen 2

Treatment:

Drug: Dupilumab