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Trial record 2 of 63 for:    regeneron | Recruiting, Not yet recruiting, Available Studies

Safety, Pharmacokinetics and Efficacy of Dupilumab in Patients ≥6 Months to <6 Years With Severe Atopic Dermatitis (Liberty AD PRESCHOOL)

This study is not yet open for participant recruitment.
Verified November 2017 by Regeneron Pharmaceuticals
Sponsor:
ClinicalTrials.gov Identifier:
NCT03346434
First Posted: November 17, 2017
Last Update Posted: November 17, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
  Purpose
This study is a 2-part (parts A and B) phase 2/3 study to evaluate the safety, pharmacokinetics (PK) and efficacy of dupilumab in patients 6 months to less than 6 years of age with severe atopic dermatitis (AD).

Condition Intervention Phase
Dermatitis, Atopic Drug: Dupilumab Drug: Matching placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:

Part A: Single-ascending-dose cohorts staggered by age;

Part B: Parallel Group

Masking: None (Open Label)
Masking Description:

Part A: Open Label;

Part B: Masked, Randomized

Primary Purpose: Treatment
Official Title: A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Dupilumab in Patients Aged ≥6 Months to <6 Years With Severe Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Part A: Pharmacokinetic (PK) parameter - Maximum observed concentration (Cmax) [ Time Frame: Baseline to week 4 ]
    Peak dupilumab concentration in serum following single-dose administration

  • Part A: PK parameter - Time to reach maximum observed concentration (Tmax) time [ Time Frame: Baseline to week 4 ]
  • Part A: PK parameter - Area under the concentration-time curve (AUC) from time zero to the time of the last measurable concentration (AUClast) [ Time Frame: Baseline to week 4 ]
    AUC computed from time zero to the time of the last positive concentration

  • Part A: Incidence of Treatment-Emergent Adverse Events (TEAEs) [Safety and Tolerability] [ Time Frame: Baseline to week 8 ]
    TEAEs include adverse events (AEs), serious adverse events (SAEs), deaths, and laboratory abnormalities

  • Part B: Proportion of patients with an Investigator Global Assessment (IGA) score of 0 to 1 (on a 5-point scale) at week 16 [ Time Frame: At week 16 ]

Secondary Outcome Measures:
  • Part A: Incidence of Serious Adverse Events (SAEs) [ Time Frame: Baseline to week 4 ]
  • Part A: Incidence of severe TEAEs [ Time Frame: Baseline to week 4 ]
  • Part A: Percent change in EASI score [ Time Frame: Baseline to week 4 ]
  • Part A: Percent change in SCORing Atopic Dermatitis (SCORAD) score [ Time Frame: Baseline to week 4 ]
  • Part A: Proportion of patients with an IGA score of either 0 or 1 (on a 5-point scale) [ Time Frame: At week 4 ]
  • Part A: Determine immunogenicity titer [ Time Frame: Baseline to week 4 ]
    Assessed by measurement of anti-drug antibodies

  • Part B: Proportion of patients with EASI-75 (≥75% improvement from baseline) [ Time Frame: At week 16 ]
  • Part B: Percent change in EASI score [ Time Frame: Baseline to week 16 ]
  • Part B: Reduction in pruritus (appropriate measure and endpoint definition in this patient population to be determined) [ Time Frame: At week 16 ]
  • Part B: Proportion of patients with EASI-50 (≥50% improvement from baseline) [ Time Frame: At week 16 ]
  • Part B: Proportion of patients with EASI-90 (≥90% improvement from baseline) [ Time Frame: At week 16 ]
  • Part B: Change in percent Body Surface Area (BSA) affected by AD [ Time Frame: Baseline to week 16 ]
  • Part B: Percent change in SCORAD [ Time Frame: Baseline to week 16 ]
  • Part B: Change in Children's Dermatology Life Quality Index (CDLQI) for patients ≥4 years of age [ Time Frame: Baseline to week 16 ]
  • Part B: Change in Infants' Dermatology Quality of Life Index (IDQOL) for patients <4 years of age [ Time Frame: Baseline to week 16 ]
  • Part B: Change in Dermatitis Family Index (DFI) [ Time Frame: Baseline to week 16 ]
  • Part B: Change in Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline to week 16 ]
  • Part B: Topical treatment for AD - proportion of medication-free days [ Time Frame: Baseline to week 16 ]
  • Part B: Mean weekly dose of Topical corticosteroids [ Time Frame: Baseline to week 16 ]
  • Part B: Mean of caregiver missed workdays [ Time Frame: Baseline to week 16 ]
  • Part B: Incidence of skin infection TEAEs [ Time Frame: Baseline to week 16 ]
  • Part B: Incidence of SAEs through week 16 [ Time Frame: Baseline to week 16 ]

Estimated Enrollment: 280
Anticipated Study Start Date: December 1, 2017
Estimated Study Completion Date: March 29, 2022
Estimated Primary Completion Date: January 6, 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part A (Open label Dupilumab): Age cohorts 1 & 2

Age cohort 1: ≥2 years old to <6 years old

Age cohort 2: ≥6 months to <2 years old

Drug: Dupilumab
Solution for injection, subcutaneous (SC)
Other Names:
  • DUPIXENT®
  • REGN668
  • SAR231893
Experimental: Part B (Double-blind): Dupilumab dose 1
The results of part A will be used to guide the selection of dose levels and dosing frequency for part B.
Drug: Dupilumab
Solution for injection, subcutaneous (SC)
Other Names:
  • DUPIXENT®
  • REGN668
  • SAR231893
Experimental: Part B (Double-blind): Dupilumab dose 2
The results of part A will be used to guide the selection of dose levels and dosing frequency for part B.
Drug: Dupilumab
Solution for injection, subcutaneous (SC)
Other Names:
  • DUPIXENT®
  • REGN668
  • SAR231893
Experimental: Part B (Double-Blind): Placebo Drug: Matching placebo
Solution for injection, subcutaneous (SC)

Detailed Description:
  1. Part A (open-label, single-ascending-dose, sequential cohort phase 2 study):

    • Primary objective is to characterize the safety and PK of dupilumab administered as a single dose in pediatric patients, 6 months to less than 6 years of age, with severe AD.
    • Secondary objective is to evaluate the efficacy and immunogenicity of a single dose of dupilumab in patients 6 months to less than 6 years of age with severe AD
  2. Part B (randomized, double-blind, parallel-group, placebo-controlled phase 3 study):

    • Primary objective is to demonstrate the efficacy of multiple doses of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in pediatric patients, 6 months to less than 6 years of age, with severe AD.
    • Secondary objective is to assess the safety and immunogenicity of multiple doses of dupilumab over 16 weeks of treatment when administered concomitantly with TCS in patients 6 months to less than 6 years of age with severe AD
  Eligibility

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:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria

  1. Diagnosis of AD according to the American Academy of Dermatology consensus criteria at the screening visit
  2. Patients with documented recent history (within 6 months before the screening visit) of inadequate response to topical AD medication(s)
  3. IGA = 4 at screening and baseline visits
  4. EASI ≥21 at screening and baseline visits
  5. Body Surface Area (BSA) ≥15% at screening and baseline visits

Key Exclusion Criteria

  1. Participation in a prior dupilumab clinical study
  2. History of important side effects of medium potency topical corticosteroids (only applicable for part B of the study)
  3. Having used immunosuppressive/immunomodulating drugs within 4 weeks before the baseline visit
  4. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
  5. Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiprotozoals, or antifungals within 2 weeks before the baseline visit.
  6. Known history of human immunodeficiency virus (HIV) infection or HIV seropositivity at the screening visit
  7. History of malignancy at any time before the baseline visit
  8. Diagnosed active endoparasitic infections or at high risk of these infections
  9. 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

  Contacts and Locations
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): NCT03346434


Contacts
Contact: Clinical Trials Administrator 844-734-6643 clinicaltrials@regeneron.com

Locations
United States, Texas
Clinical Trial Site Not yet recruiting
San Antonio, Texas, United States, 78218
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03346434     History of Changes
Other Study ID Numbers: R668-AD-1539
2016-000955-28 ( EudraCT Number )
First Submitted: February 6, 2017
First Posted: November 17, 2017
Last Update Posted: November 17, 2017
Last Verified: November 2017

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