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Study to Assess the Long-term Safety of Dupilumab Administered in Participants ≥6 Months to <18 Years of Age With Atopic Dermatitis (AD)

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ClinicalTrials.gov Identifier: NCT02612454
Recruitment Status : Enrolling by invitation
First Posted : November 23, 2015
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The primary objective of the study is to assess the long-term safety of dupilumab in pediatric participants with AD.

The secondary objectives of the study are:

  • To assess the long-term efficacy of dupilumab in pediatric participants with AD
  • To assess the trough concentrations of functional dupilumab in serum and the immunogenicity in pediatric participants with AD after re-treatment with dupilumab.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Dupilumab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 765 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension Study to Assess the Long-Term Safety and Efficacy of Dupilumab in Patients ≥6 Months to <18 Years of Age With Atopic Dermatitis
Actual Study Start Date : October 15, 2015
Estimated Primary Completion Date : January 25, 2024
Estimated Study Completion Date : January 25, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Age ≥6 months to <18 years
Participants aged ≥6 months to <18 years will receive dupilumab
Drug: Dupilumab
Other Names:
  • DUPIXENT®
  • REGN668
  • SAR231893




Primary Outcome Measures :
  1. Rate of treatment-emergent adverse events (TEAEs) per participant year from baseline through the last study visit [ Time Frame: Baseline up to week 272 ]
  2. Number of participants with at least one TEAE per participant year from baseline through the last study visit [ Time Frame: Baseline up to week 272 ]

Secondary Outcome Measures :
  1. Number of treatment-emergent serious adverse events (SAEs) from baseline through the last study visit [ Time Frame: Baseline up to week 272 ]
  2. Incidence of TEAEs of special interest from baseline through the last study visit [ Time Frame: Baseline up to week 272 ]
  3. Proportion of participants with an Investigator Global Assessment (IGA) score of 0 or 1 (clear or almost clear) at all in-clinic visits post-baseline [ Time Frame: Baseline up to week 272 ]
  4. Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% reduction in EASI from baseline of parent study) response at all in-clinic visits post-baseline [ Time Frame: Baseline up to week 272 ]
  5. Change from baseline in EASI score at all in-clinic visits post-baseline [ Time Frame: Baseline up to week 272 ]
  6. Percent change from baseline in EASI at all in-clinic visits post-baseline [ Time Frame: Baseline up to week 272 ]
  7. Change from baseline in Body Surface Area (BSA) affected by AD (BSA) at all in-clinic visits post-baseline [ Time Frame: Baseline up to week 272 ]
  8. Percent change from baseline in SCORing Atopic Dermatitis (SCORAD) at all in-clinic visits post-baseline [ Time Frame: Baseline up to week 272 ]
  9. Change from baseline in Children's Dermatology Life Quality Index (CDLQI) for participants ≥4 years of age at all in-clinic visits post-baseline in which the assessments are planned to be performed [ Time Frame: Baseline up to week 272 ]
  10. Change from baseline in Infants' Dermatology Quality of Life Index (IDQOL) for participants <4 years of age at all in-clinic visits post-baseline in which the assessments are planned to be performed [ Time Frame: Baseline up to week 272 ]
  11. Proportion of responders (defined as participants with IGA 0 or 1) who maintain IGA 0 or 1 during at least 75% of the subsequent* visits during the treatment period [ Time Frame: Baseline to week 260 ]
    *Subsequent refers to the visits following the first visit at which IGA 0 or 1 is achieved.

  12. For responders (defined as participants with IGA 0 or 1), median percentage of subsequent* visits during the treatment period, at which IGA 0 or 1 is maintained [ Time Frame: Baseline to week 260 ]
    *Subsequent refers to the visits following the first visit at which IGA 0 or 1 is achieved.

  13. Number of AD flares during the study [ Time Frame: Baseline to week 272 ]
    AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment

  14. Annualize event rate of AD flares during the study [ Time Frame: Baseline to week 272 ]
    AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment

  15. Proportion of participants with at least one flare during the study [ Time Frame: Baseline to week 272 ]
    AD flares are defined as worsening of the disease that requires escalation/intensification of AD treatment

  16. Proportion of well-controlled weeks [ Time Frame: Baseline to week 272 ]
    Well-controlled weeks are those for which participants or parents/caregivers answer "Yes" AND during which no rescue treatments were administered



Information from the National Library of Medicine

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

Key Inclusion Criteria:

1. Participated in a prior dupilumab study in pediatric patients with AD and adequately completed the visits and assessments required for both the treatment and follow-up periods, as defined in the prior study protocol

Key Exclusion Criteria:

  1. Patients who, during their participation in a prior dupilumab study developed an adverse event (AE) or serious adverse event (SAE) deemed related to study drug which could indicate that continued treatment with study drug may present an unreasonable risk for the patient
  2. Patients, who during the participation in a prior Dupilumab study, developed an AE that was deemed related to study drug and led to study treatment discontinuation, which in the opinion of the investigator or medical monitor could indicate that continued treatment with study drug may present an unreasonable risk for the patient
  3. Treatment with an investigational drug, other than dupilumab, within 8 weeks or within 5 half-lives (if known), whichever is longer, before the baseline visit
  4. Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
  5. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
  6. Diagnosed active endoparasitic infections or at high risk of these infections
  7. Severe concomitant illness(es) that, in the investigator's judgment, would adversely affect the patient's participation in the study.

Note: Other protocol defined Inclusion / Exclusion criteria may apply


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): NCT02612454


  Show 92 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02612454     History of Changes
Other Study ID Numbers: R668-AD-1434
First Posted: November 23, 2015    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

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