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

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ClinicalTrials.gov Identifier: NCT02407756
Recruitment Status : Completed
First Posted : April 3, 2015
Last Update Posted : August 22, 2016
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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).


Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Dupilumab Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Cohort 1
Cohort 1 will receive dupilumab dosing regimen 1
Drug: Dupilumab
Other Name: REGN668(SAR231893)

Experimental: Cohort 2
Cohort 2 will receive dupilumab dosing regimen 2
Drug: Dupilumab
Other Name: REGN668(SAR231893)




Primary Outcome Measures :
  1. Pharmacokinetic (PK) parameters [ Time Frame: Baseline to week 12 ]

    The primary objective of characterizing the PK profiles of dupilumab in pediatric AD patients aged ≥6 to <18 years will be addressed by PK parameters.

    PK parameters may include, but are not limited to, the following:

    • Dupilumab concentration in serum over time
    • Cmax - peak dupilumab concentration in serum following single dose administration
    • Cmax/Dose - Cmax-to-dose ratio
    • Ctrough - trough dupilumab concentration in serum
    • CtroughSS - steady-state trough dupilumab concentration in serum
    • Clast - last positive (quantifiable) dupilumab concentration in serum


Secondary Outcome Measures :
  1. Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to week 12 ]
  2. Percent change from baseline in Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to week 12 ]
  3. Percent change from baseline in SCORing Atopic Dermatitis (SCORAD) score [ Time Frame: Baseline to week 12 ]
  4. Percent change from baseline in Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline to week 12 ]
  5. Percentage of patients with an Investigator Global Assessment (IGA) score of 0 or 1 [ Time Frame: Baseline to week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407756


Locations
Canada, Ontario
Markham, Ontario, Canada
Peterborough, Ontario, Canada
Waterloo, Ontario, Canada
Windsor, Ontario, Canada
Czech Republic
Kutna Hora, Czech Republic
Prague, Czech Republic
Germany
Dresden, Germany
Frankfurt, Germany
Gera, Germany
Hamburg, Germany
Kiel, Germany
Luebeck, Germany
Muenster, Germany
Munich, Germany
Tuebingen, Germany
Hungary
Kaposvar, Hungary
Miskolc, Hungary
Szeged, Hungary
Szolnok, Hungary
Poland
Katowice, Poland
Krakow, Poland
Lodz, Poland
Warszawa, Poland
Wroclaw, Poland
United Kingdom
Manchester, United Kingdom
Sheffield, United Kingdom
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02407756     History of Changes
Other Study ID Numbers: R668-AD-1412
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016

Keywords provided by Regeneron Pharmaceuticals:
Eczema

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs