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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02407756
• Date of registration: 31/03/2015
• Prospective Registration: Yes
• Primary sponsor: Regeneron Pharmaceuticals
• Public title: A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged =6 to <18 Years With Atopic Dermatitis (Eczema)
• Scientific title: A Phase 2a Study Investigating the Safety, Pharmacokinetics, Immunogenicity, and Exploratory Efficacy of Dupilumab in Patients Aged =6 to <18 Years With Atopic Dermatitis
• Date of first enrolment: March 31, 2015
• Target sample size: 78
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02407756
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada, Czech Republic, Czechia, Germany, Hungary, Poland, United Kingdom

Contacts

• Name: Clinical Trial Management
• Affiliation: Regeneron Pharmaceuticals

Key inclusion & 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



Age minimum: 6 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Atopic Dermatitis

Intervention(s)

Drug: Dupilumab

Primary Outcome(s)

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]

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]

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]

Secondary Outcome(s)

Percent Reduction From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Week 12 [Time Frame: Baseline to Week 12 (one week after last dose)]

Percent Reduction From Baseline in Eczema Area and Severity Index (EASI) at Week 12 [Time Frame: Baseline to Week 12 (one week after last dose)]

Percent Reduction From Baseline in Body Surface Area (BSA) at Week 12 [Time Frame: Baseline to Week 12]

Percent Reduction From Baseline in Pruritus Numerical Rating Scale (NRS) at Week 12 [Time Frame: 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 [Time Frame: Week 12]

Secondary ID(s)

R668-AD-1412

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sanofi

Results

• Results available: Yes
• Date Posted: 05/10/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02407756