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Trial record 3 of 53 for:    regeneron | Open Studies

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2017 by Regeneron Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT03054428
First received: February 13, 2017
Last updated: NA
Last verified: February 2017
History: No changes posted
  Purpose
To demonstrate the efficacy of dupilumab as a monotherapy in patients ≥12 years to <18 years of age with moderate-to-severe atopic dermatitis (AD)

Condition Intervention Phase
Moderate-to-Severe Atopic Dermatiti
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: Placebos
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator
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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Proportion of patients with Investigator Global Assessment (IGA) 0 to 1 (on a 5-point scale) (For US and ex-US) [ Time Frame: At week 16 ]
  • Proportion of patients with Eczema Area and Severity (EASI) EASI-75 (≥75% improvement from baseline) (For ex-US) [ Time Frame: At week 16 ]

Secondary Outcome Measures:
  • Proportion of patients with EASI-75 (≥75% improvement from baseline) (for US) [ Time Frame: At week 16 ]
  • Percent change in EASI score [ Time Frame: Baseline to week 16 ]
  • Percent change in weekly average of daily peak Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline to week 16 ]
  • Proportion of patients with improvement (reduction) of weekly average of daily peak Pruritus NRS ≥4 [ Time Frame: Baseline to week 16 ]
  • Change in weekly average of daily peak Pruritus NRS [ Time Frame: Baseline to week 16 ]
  • Proportion of patients with improvement (reduction) of weekly average of daily peak Pruritus NRS ≥3 [ Time Frame: Baseline to week 16 ]
  • Proportion of patients with EASI-50 [ Time Frame: At week 16 ]
  • Proportion of patients with EASI-90 [ Time Frame: At week 16 ]
  • Change in percent body surface area (BSA) affected by AD [ Time Frame: Baseline to week 16 ]
  • Percent change in SCORing Atopic Dermatitis (SCORAD) [ Time Frame: Baseline to week 16 ]
  • Change in Children's Dermatology Life Quality Index (CDLQI) [ Time Frame: Baseline to week 16 ]
  • Change in Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline to week 16 ]
  • Percent change in weekly average of daily peak Pruritus (NRS) [ Time Frame: Baseline to week 4 ]
  • Proportion of patients with improvement (reduction) of weekly average of daily peak Pruritus NRS ≥4 [ Time Frame: Baseline to week 4 ]
  • Change in Hospital Anxiety and Depression Scale (HADS) [ Time Frame: Baseline to week 16 ]
  • Incidence of skin-infection treatment-emergent adverse events (TEAEs) (excluding herpetic infections) [ Time Frame: Baseline to week 16 ]
  • Incidence of serious TEAEs [ Time Frame: Baseline to week 16 ]

Estimated Enrollment: 240
Anticipated Study Start Date: March 2017
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Dose regimen 3 - Drug: Placebo
Drug: Placebos
Placebo

  Eligibility

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 Numerical Rating Scale (NRS) average score for maximum itch intensity ≥4
  • ≥10% body surface area (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 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

  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: NCT03054428

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03054428     History of Changes
Other Study ID Numbers: R668-AD-1526  2015-004458-16 
Study First Received: February 13, 2017
Last Updated: February 13, 2017

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

ClinicalTrials.gov processed this record on February 17, 2017