ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    R668-AD-1526
Previous Study | Return to List | Next Study

Efficacy and Safety of Dupilumab in Patients ≥12 to <18 Years of Age, With Moderate-to-Severe Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03054428
Recruitment Status : Completed
First Posted : February 15, 2017
Last Update Posted : August 2, 2018
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
To demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to <18 years of age with moderate-to-severe atopic dermatitis (AD)

Condition or disease Intervention/treatment Phase
Moderate-to-Severe Atopic Dermatitis Dermatitis, Dermatitis Atopic Eczema, Skin Diseases, Skin Diseases Genetic, Genetic Diseases Inborn, Skin Disease, Eczematous Skin Hypersensitivity, Immediate Hypersensitivity, Immune System Diseases Dermatitis, Atopic Drug: Dupilumab Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 251 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Dupilumab Monotherapy in Patients ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis
Actual Study Start Date : March 21, 2017
Actual Primary Completion Date : April 4, 2018
Actual Study Completion Date : June 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Arm 1
Dose regimen 1 - Drug: Dupilumab
Drug: Dupilumab
Dupilumab as per protocol

Experimental: Arm 2
Dose regimen 2 - Drug: Dupilumab
Drug: Dupilumab
Dupilumab as per protocol

Experimental: Arm 3
Placebo
Drug: Placebo
Matching placebo




Primary Outcome Measures :
  1. Proportion of participants with Investigator Global Assessment (IGA) 0 to 1 (on a 5-point scale) [ Time Frame: At week 16 ]
    The IGA is an assessment instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 (clear) to 4 (severe).


Secondary Outcome Measures :
  1. Proportion of participants with Eczema Area and Severity Index (EASI)-75 (≥75% improvement from baseline) [ Time Frame: At week 16 ]
    The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD. The EASI is a composite index with scores ranging from 0 to 72.

  2. Percent change in EASI score [ Time Frame: Baseline to week 16 ]
  3. Percent change in weekly average of daily peak Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline to week 16 ]
    The Pruritus NRS is an assessment tool that participants will use to report the intensity of their pruritus (itch) during a 24-hour recall period.

  4. Proportion of participants with improvement (reduction) of weekly average of daily peak Pruritus NRS ≥3 [ Time Frame: Baseline to week 16 ]
  5. Proportion of participants with improvement (reduction) of weekly average of daily peak Pruritus NRS ≥4 [ Time Frame: Baseline to week 16 ]
  6. Proportion of patients with EASI-50 (≥50% improvement from baseline) [ Time Frame: At week 16 ]
  7. Proportion of patients with EASI-90 (≥90% improvement from baseline) [ Time Frame: At week 16 ]
  8. Time to onset of effect on pruritus during the 16-week treatment period (≥3 point reduction of weekly average of peak Pruritus NRS from baseline [ Time Frame: Baseline to week 16 ]
  9. Time to onset of effect on pruritus during the 16-week treatment period (≥4 point reduction of weekly average of peak Pruritus NRS from baseline [ Time Frame: Baseline to week 16 ]
  10. Change in percent body surface area (BSA) affected by AD [ Time Frame: Baseline to week 16 ]
  11. Percent change in SCORing Atopic Dermatitis (SCORAD) [ Time Frame: Baseline to week 16 ]
    The SCORing Atopic Dermatitis (SCORAD) is a validated tool used in clinical research and clinical practice. There are 3 components to the assessment: A = extent or affected body surface area, B = severity, and C = subjective symptoms.

  12. Change in Children's Dermatology Life Quality Index (CDLQI) [ Time Frame: Baseline to week 16 ]
    The CDLQI is a validated questionnaire designed to measure the impact of skin disease on the quality of life (QOL) in children. The CDLQI for a patient is the sum of the score of each question with a maximum of 30 and a minimum of 0. The higher the score, the greater the impact is on the QOL.

  13. Change in Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline to week 16 ]
    The POEM is a 7-item, validated questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults.

  14. Change in weekly average of daily peak Pruritus NRS [ Time Frame: Baseline to week 16 ]
  15. Percent change in weekly average of daily peak Pruritus NRS [ Time Frame: Baseline to week 4 ]
  16. Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline to week 16 ]
    The HADS is an instrument for screening anxiety and depression in non-psychiatric populations; repeated administration also provides information about changes to a patient's emotional state. The HADS consists of 14 items, 7 each for anxiety and depression symptoms; possible scores range from 0 to 21 for each subscale

  17. Proportion of participants with improvement (reduction) of weekly average of daily peak Pruritus NRS ≥4 [ Time Frame: Baseline to week 4 ]
  18. Incidence of skin-infection treatment-emergent adverse events (TEAEs) (excluding herpetic infections) [ Time Frame: Baseline to week 16 ]
  19. Incidence of serious TEAEs [ Time Frame: Baseline to week 16 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female ≥12 to <18 years of age at time of screening visit
  • Diagnosis of AD according to the American Academy of Dermatology consensus criteria at screening visit
  • IGA ≥3 at screening and baseline visit
  • EASI ≥16 at the screening and baseline visit
  • Baseline Pruritus NRS average score for maximum itch intensity ≥4
  • ≥10% BSA of AD involvement at the screening and baseline visits
  • With documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s) or for whom topical treatments is medically inadvisable

Exclusion Criteria:

  • Participation in a prior dupilumab clinical study
  • Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 2 weeks before the baseline visit
  • Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
  • Body weight <30 kg at baseline
  • Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit
  • Known or suspected immunodeficiency, known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit, established diagnosis of HBV infection or HBV seropositivity at screening, established diagnosis of HCV infection or HCV seropositivity at screening
  • History of malignancy before the baseline visit
  • Diagnosed active endoparasitic infections or at high risk of these infections
  • Patient is female who is pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
  • Patient is female of childbearing potential and sexually active, who is unwilling to use adequate methods of contraception throughout the duration of the study and for 120 days after the last dose of study drug

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): NCT03054428


  Show 52 Study Locations
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03054428     History of Changes
Other Study ID Numbers: R668-AD-1526
2015-004458-16 ( EudraCT Number )
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: June 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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