A study to determine the safety and tolerability of REGN668 in patients aged =6 to <18 years with atopic dermatitis (eczema)
- Conditions
- Atopic dermatitsMedDRA version: 17.1 Level: LLT Classification code 10003639 Term: Atopic dermatitis System Organ Class: 100000004858Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2014-003263-37-GB
- Lead Sponsor
- Regeneron Pharmaceuticals, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 78
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)
a. IGA = 3 or 4 in adolescents =12 to <18 year of age
b. IGA = 4 in children =6 to <12 years of age
Are the trial subjects under 18? yes
Number of subjects for this age range: 80
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
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:
a. Any systemic infection requiring treatment within 4 weeks before the baseline visit
b. Superficial skin infections within 1 week before the baseline visit
c. Known history of HIV infection
d. History of seropositivity to hepatitis B or C screening tests
e. 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Primary end point(s): The primary objective of characterizing the PK profiles of dupilumab in pediatric<br> AD patients aged =6 to <18 years will be addressed by PK parameters.<br> ;Timepoint(s) of evaluation of this end point: Throughout the duration of the study;Main Objective: 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).;Secondary Objective: 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).
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): The secondary objectives are:<br> - Incidence of treatment-emergent adverse events (TEAEs)<br> - Percent change from baseline in Eczema Area and Severity Index (EASI)<br> - Percent change from baseline in SCORing Atopic Dermatitis (SCORAD)<br> score<br> - Percent change from baseline in Pruritus Numerical Rating Scale (NRS)<br> - Percentage of patients with an Investigator Global Assessment (IGA) score<br> of 0 or 1<br> ;Timepoint(s) of evaluation of this end point: Throughout the duration of the study