A Phase 2a Study Investigating the Safety, Pharmacokinetics, Immunogenicity, and Exploratory Efficacy of Dupilumab in Patients Aged ≥6 to <18 Years With Atopic Dermatitis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 78
- Primary Endpoint
- Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Male or female patients ≥6 to <18 years of age with a diagnosis of
- •Atopic Dermatitis whose disease cannot be adequately controlled with topical medications
- •Minimum disease severity, as defined by Investigator's Global Assessment (IGA)
- •IGA = 3 or 4 in adolescents ≥12 to <18 year of age
- •IGA = 4 in children ≥6 to <12 years of age
Exclusion Criteria
- •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
- •History of any of the following infections:
- •Any systemic infection requiring treatment within 4 weeks before the baseline visit
- •Superficial skin infections within 1 week before the baseline visit
- •Known history of HIV infection
- •History of seropositivity to hepatitis B or C screening tests
- •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
- •History of malignancy within 5 years before the baseline visit
- •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
- •Presence of any severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study
- •Presence of skin comorbidities that may interfere with study assessments
- •Females patients who are pregnant or breastfeeding
- •Female patients who are of reproductive potential and are sexually active, who are unwilling to use adequate methods of contraception
Arms & Interventions
Cohort 1
Cohort 1 will receive dupilumab dosing regimen 1
Intervention: Dupilumab (Drug)
Cohort 2
Cohort 2 will receive dupilumab dosing regimen 2
Intervention: Dupilumab (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (PK) of Dupilumab: Maximum Plasma Concentration Observed (Cmax) After Single Administration
Time Frame: Day 2, 4, 8, 15, 22, 29, 36, 43, and 50
Peak dupilumab concentration in serum following single dose administration. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.
PK of Dupilumab: Area Under the Plasma Concentration Versus Time Curve (AUClast) After Single Administration
Time Frame: Day 2, 4, 8, 15, 22, 29, 36, 43, and 50
Mean AUC estimates were calculated using mean concentration data at each time point, using a non-compartmental approach (NCA). Calculated AUClast (computed from time zero to the time of the last positive concentration) are presented. Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of the study drug.
PK of Dupilumab: Trough Dupilumab Concentration in Serum (Ctrough) Before 3rd and 4th Repeated Dose
Time Frame: Pre-dose on Day 71 and Day 85
Analysis was performed on PK analysis set that included all treated subjects who received the study medication and had at least 1 quantified (non-missing) result for dupilumab concentration following the first dose of study drug.
Secondary Outcomes
- Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12(Baseline to Week 12 (one week after last dose))
- Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12(Baseline to Week 12 (one week after last dose))
- Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12(Baseline to Week 12 (one week after last dose))
- Percentage of Subjects With Investigator Global Assessment (IGA) Score of "0" or "1" (Clear or Almost Clear) at Week 12(Week 12)
- Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12(Baseline to Week 12)