A study to determine the safety and tolerability of REGN668 in patients aged =6 to <18 years with atopic dermatitis (eczema)

• Conditions: Atopic dermatits; MedDRA version: 18.0Level: LLTClassification code 10003639Term: Atopic dermatitisSystem Organ Class: 100000004858; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-003263-37-PL
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-27
• Last Update Posted: 25 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. 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
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

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:
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