Trial record 3 of 44 for:    regeneron | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Regeneron Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02407756
First received: March 31, 2015
Last updated: NA
Last verified: March 2015
History: No changes posted
  Purpose

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 objectives of the trial 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 Intervention Phase
Atopic Dermatitis
Drug: Dupilumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Pharmacokinetic (PK) parameters [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]

    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:
  • Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: Yes ]
  • Percent change from baseline in Eczema Area and Severity Index (EASI) [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • Percent change from baseline in SCORing Atopic Dermatitis (SCORAD) score [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • Percent change from baseline in Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]
  • Percentage of patients with an Investigator Global Assessment (IGA) score of 0 or 1 [ Time Frame: Baseline to week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: March 2015
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   6 Years to 17 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02407756

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
Canada, Ontario
Recruiting
Barrie, Ontario, Canada
Recruiting
Markham, Ontario, Canada
Not yet recruiting
Oakville, Ontario, Canada
Not yet recruiting
Peterborough, Ontario, Canada
Recruiting
Waterloo, Ontario, Canada
Recruiting
Windsor, Ontario, Canada
Czech Republic
Not yet recruiting
Kutna Hora, Czech Republic
Not yet recruiting
Prague, Czech Republic
Germany
Not yet recruiting
Bonn, Germany
Not yet recruiting
Dresden, Germany
Not yet recruiting
Frankfurt, Germany
Not yet recruiting
Gera, Germany
Not yet recruiting
Hamburg, Germany
Not yet recruiting
Kiel, Germany
Not yet recruiting
Luebeck, Germany
Not yet recruiting
Muenster, Germany
Not yet recruiting
Munich, Germany
Not yet recruiting
Tuebingen, Germany
Hungary
Not yet recruiting
Budapest, Hungary
Not yet recruiting
Kaposvar, Hungary
Not yet recruiting
Miskolc, Hungary
Not yet recruiting
Szeged, Hungary
Recruiting
Szolnok, Hungary
Poland
Recruiting
Bydgoszcz, Poland
Recruiting
Katowice, Poland
Recruiting
Krakow, Poland
Recruiting
Lodz, Poland
Recruiting
Warszawa, Poland
Not yet recruiting
Wroclaw, Poland
United Kingdom
Not yet recruiting
Cardiff, United Kingdom
Not yet recruiting
Leeds, United Kingdom
Not yet recruiting
Manchester, United Kingdom
Not yet recruiting
Sheffield, United Kingdom
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02407756     History of Changes
Other Study ID Numbers: R668-AD-1412
Study First Received: March 31, 2015
Last Updated: March 31, 2015
Health Authority: Canada: Health Canada
Czech Republic: State Institute for Drug Control
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
United Kingdom: Medicine and Healthcare Products Regulatory Agency

Keywords provided by Regeneron Pharmaceuticals:
Eczema

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on June 30, 2015