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Study to Investigate the Efficacy and Safety of Dupilumab Administered With Topical Corticosteroids (TCS) in Participants ≥6 to <12 Years With Severe Atopic Dermatitis (AD)

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ClinicalTrials.gov Identifier: NCT03345914
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:

The main objective of the trial is to demonstrate the efficacy of dupilumab administered concomitantly with topical corticosteroids (TCS) in participants ≥6 years to <12 years of age with severe atopic dermatitis (AD).

The secondary objective is to assess the safety of dupilumab administered concomitantly with TCS in patients ≥6 years to <12 years of age with severe AD.


Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: Dupilumab Drug: Matching Placebo Other: Background Treatment: Topical Corticosteroids Other: Background Treatment: Moisturizers Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 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 Administered Concomitantly With Topical Corticosteroids in Patients, ≥6 Years to <12 Years of Age, With Severe Atopic Dermatitis
Actual Study Start Date : November 17, 2017
Estimated Primary Completion Date : June 20, 2019
Estimated Study Completion Date : September 12, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Steroids
Drug Information available for: Dupilumab

Arm Intervention/treatment
Experimental: Group 1
Participants will receive dupilumab, dosing regimen 1
Drug: Dupilumab

Pharmaceutical form: Solution for injection in pre-filled syringe;

Route of administration: Subcutaneous (SC)

Other Names:
  • DUPIXENT®
  • REGN668
  • SAR231893

Other: Background Treatment: Topical Corticosteroids
All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.

Other: Background Treatment: Moisturizers
All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.

Experimental: Group 2
Participants will receive dupilumab, dosing regimen 2
Drug: Dupilumab

Pharmaceutical form: Solution for injection in pre-filled syringe;

Route of administration: Subcutaneous (SC)

Other Names:
  • DUPIXENT®
  • REGN668
  • SAR231893

Other: Background Treatment: Topical Corticosteroids
All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.

Other: Background Treatment: Moisturizers
All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.

Experimental: Group 3
Participants will receive matching placebo
Drug: Matching Placebo

Pharmaceutical form: Solution for injection;

Route of administration: Subcutaneous (SC)


Other: Background Treatment: Topical Corticosteroids
All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.

Other: Background Treatment: Moisturizers
All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.




Primary Outcome Measures :
  1. Proportion of participants with Investigator's Global Assessment (IGA) "0" or "1" (on a 5-point scale) at week 16 [ Time Frame: At week 16 ]

Secondary Outcome Measures :
  1. Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75% improvement from baseline) at week 16 [ Time Frame: At week 16 ]
    Co-primary endpoint for European Medicines Agency (EMA) and EMA Reference Market Countries only

  2. Percent change in EASI score from baseline to week 16 [ Time Frame: Baseline to week 16 ]
  3. Percent change from baseline to week 16 in weekly average of daily worst itch score [ Time Frame: Baseline to week 16 ]
  4. Change from baseline to week 16 in weekly average of daily worst itch score [ Time Frame: Baseline to week 16 ]
  5. Proportion of participants with EASI-50 (≥50% improvement from baseline) at week 16 [ Time Frame: At week 16 ]
  6. Proportion of participants with EASI-90 (≥90% improvement from baseline) at week 16 [ Time Frame: At week 16 ]
  7. Change from baseline to week 16 in percent Body Surface Area (BSA) affected by Atopic Dermatitis (AD) [ Time Frame: Baseline to week 16 ]
  8. Percent change from baseline to week 16 in Scoring Atopic Dermatitis (SCORAD) [ Time Frame: Baseline to week 16 ]
  9. Proportion of participants with improvement (reduction) of weekly average of daily worst itch score ≥4 from baseline at week 16 [ Time Frame: At week 16 ]
  10. Proportion of participants with improvement (reduction) of weekly average of daily worst itch score ≥3 from baseline at week 16 [ Time Frame: At week 16 ]
  11. Time to onset of effect on pruritus during the 16-week treatment period (≥4 point reduction of weekly average of daily worst itch score from baseline) [ Time Frame: Baseline to week 16 ]
  12. Time to onset of effect on pruritus during the 16-week treatment period (≥3 point reduction of weekly average of daily worst itch score from baseline) [ Time Frame: Baseline to week 16 ]
  13. Change from baseline to week 16 in Children's Dermatology Life Quality Index (CDLQI) [ Time Frame: Baseline to week 16 ]
  14. Change from baseline to week 16 in Patient Oriented Eczema Measure (POEM) [ Time Frame: Baseline to week 16 ]
  15. Change from baseline to week 16 in Dermatitis Family Index (DFI) [ Time Frame: Baseline to week 16 ]
  16. Change from baseline to week 16 in Patient Reported Outcomes Measurements Information Systems (PROMIS) pediatric anxiety short form scale score [ Time Frame: Baseline to week 16 ]
  17. Change from baseline to week 16 in PROMIS pediatric depressive symptoms short form scale score [ Time Frame: Baseline to week 16 ]
  18. Topical treatment for AD - proportion of topical corticosteroids (TCS) medication-free days from baseline to week 16 [ Time Frame: Baseline to week 16 ]
  19. Mean weekly dose of TCS in grams for low and medium potency TCS from baseline to week 16 [ Time Frame: Baseline to week 16 ]
  20. Mean weekly dose of TCS in grams for high potency TCS from baseline to week 16 [ Time Frame: Baseline up to week 16 ]
  21. Incidence of skin-infection Treatment-emergent adverse events (TEAEs) (excluding herpetic infections) through week 16 [ Time Frame: Baseline to week 16 ]
  22. Incidence of serious TEAEs through week 16 [ Time Frame: Baseline to week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 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 (Eichenfield 2003) at screening visit
  2. Chronic AD diagnosed at least 1 year prior to the screening visit
  3. IGA = 4 at screening and baseline visits
  4. EASI ≥21 at the screening and baseline visits
  5. BSA ≥15% at screening and baseline visits
  6. Documented recent history (within 6 months before the baseline visit) of inadequate response to topical AD medication(s)
  7. At least 11 (of a total of 14) applications of a stable dose of topical emollient (moisturizer) twice daily during the 7 consecutive days immediately before the baseline visit

Key Exclusion Criteria:

  1. Participation in a prior dupilumab clinical study
  2. Treatment with a systemic investigational drug before the baseline visit
  3. Treatment with a topical investigational drug within 2 weeks prior to the baseline visit
  4. Treatment with crisabarole within 2 weeks prior to the baseline visit
  5. History of important side effects of medium potency topical corticosteroids (e.g, intolerance to treatment, hypersensitivity reactions, significant skin atrophy, systemic effects), as assessed by the investigator or patient's treating physician
  6. Treatment with a topical calcineurin inhibitor (TCI) within 2 weeks prior to the baseline visit
  7. Having used any of the following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, is likely to require such treatment(s) during the first 4 weeks of study treatment:

    1. Immunosuppressive/immunomodulating drugs (e.g, systemic corticosteroids, cyclosporine, mycophenolate-mofetil, interferon gamma, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
    2. Phototherapy for AD
  8. Treatment with biologics, as follows:

    1. Any cell-depleting agents including but not limited to rituximab:

      within 6 months before the baseline visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer

    2. Other biologics: within 5 half-lives (if known) or 16 weeks before the baseline visit, whichever is longer
  9. Treatment with a live (attenuated) vaccine within 4 weeks before the baseline visit
  10. Body weight <15 kg at baseline

Note: Other Inclusion/ Exclusion criteria 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): NCT03345914


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

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

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03345914     History of Changes
Other Study ID Numbers: R668-AD-1652
2016-004997-16 ( EudraCT Number )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: January 30, 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