Study to Determine the Safety and Effectiveness of Dupilumab (REGN668/SAR231893) for Treatment of Atopic Dermatitis (AD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Regeneron Pharmaceuticals
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01979016
First received: November 1, 2013
Last updated: January 23, 2014
Last verified: January 2014
  Purpose

The primary objective of the study is to assess the efficacy of dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis.


Condition Intervention Phase
Atopic Dermatitis (AD)
Drug: dupilumab
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy, Safety, Serum Concentration and Biomarker Profile of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Percent change in EASI score [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]

    The primary endpoint is the percent change in EASI (Eczema Area and Severity Index) score from day 1 (baseline) to week 16.

    [The EASI is a measure used in clinical practice and clinical trials to assess the severity and extent of AD]



Secondary Outcome Measures:
  • Proportion of patients achieving IGA score of 0 or 1 [ Time Frame: At week 16 ] [ Designated as safety issue: No ]

    Proportion of patients achieving an IGA (Investigator's Global Assessment) of clear (score = 0) or almost clear (score = 1) at week 16

    [The IGA is a scale used in clinical studies to determine severity of AD and clinical response to treatment based on a 5-point scale ranging from 0 (clear) to 4 (severe)]


  • Proportion of patients achieving IGA score reduction >/= 2 [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
    Proportion of patients achieving IGA score reduction of >/= 2 at week 16

  • Change in pruritus NRS score [ Time Frame: At week 16 ] [ Designated as safety issue: No ]

    Absolute and percent change from baseline in pruritus numerical rating scale (NRS) score at week 16

    [The Pruritus NRS is a simple assessment tool that patients will use to report the intensity of their pruritus (itch), both maximum and average intensity, during a 24-hour recall period]


  • Change in EASI score [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
    Absolute change in EASI score from baseline to week 16

  • Change in SCORAD score [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]

    Absolute and percent change in SCORAD (SCORing Atopic Dermatitis) score from baseline to week 16

    [SCORAD is a tool used in clinical research and clinical practice that was developed to standardize the evaluation of the extent and severity of AD]


  • Proportion of patients achieving a 50 to 90% reduction in SCORAD score [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
    Proportion of patients achieving SCORAD-50, SCORAD-75, and SCORAD-90 (50, 75, and 90% reduction from baseline in SCORAD score) at week 16

  • Absolute and percent change in POEM score [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]

    Absolute and percent change from baseline in Patient Oriented Eczema Measure (POEM) score

    [The POEM is a 7-item questionnaire used in clinical practice and clinical trials to assess disease symptoms in children and adults]


  • Change in Global Individual Sign Score [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]

    Changes from baseline in Global Individual Sign Score (GISS) components

    [GISS assesses individual components of the AD lesions (erythema, infiltration/papulation, excoriations, and lichenification) and rates them globally (ie, each is assessed for the whole body, not by anatomical region)]


  • Changes in GISS cumulative score [ Time Frame: baseline to week 16 ] [ Designated as safety issue: No ]
    Changes from baseline in GISS cumulative score

  • Incidence of TEAEs [ Time Frame: baseline to week 32 ] [ Designated as safety issue: No ]
    Incidence of treatment-emergent adverse events (TEAEs) from baseline through week 32 (end of study)

  • Dupilumab serum concentrations [ Time Frame: baseline to week 32 ] [ Designated as safety issue: No ]
    Dupilumab serum concentrations over time from baseline through week 32 (end of study)


Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Drug: dupilumab

Dupilumab is an anti-interleukin 4 monoclonal antibody (Anti-IL-4R alpha mAb) that is being studied for the treatment of moderate-to-severe eczema.

[In addition to active dupilumab treatment, patients are also required to apply a topical emollient twice daily from day -7 through day 8 as background treatment.]

Other Names:
  • REGN668
  • SAR231893
Placebo Comparator: Group B Drug: placebo

Placebo is a look-alike substance with no active medication

[In addition to receiving placebo, patients are also required to apply a topical emollient twice daily from day -7 through day 8 as background treatment]


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18 years or older
  2. Chronic AD that has been present for at least 3 years before the screening visit
  3. Patients with documented recent history (within 6 months before the screening visit) of inadequate response to outpatient treatment with topical medications, or for whom topical treatments are otherwise inadvisable
  4. Willing and able to comply with all clinic visits and study-related procedures

Exclusion Criteria:

  1. Prior participation in a dupilumab clinical trial
  2. Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit
  3. The following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment:

    • Systemic corticosteroids
    • Immunosuppressive/immunomodulating drugs
    • Phototherapy for AD
  4. Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit
  5. Treatment with certain biologics
  6. Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit
  7. Planned major surgical procedure during the patient's participation in this study
  8. Patient is a member of the investigational team or his/her immediate family
  9. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
  10. Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study

Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial therefore not all inclusion/ exclusion criteria are listed.

  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: NCT01979016

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, Illinois
Recruiting
Chicago, Illinois, United States
United States, New York
Recruiting
New York (2 locations), New York, United States
United States, Texas
Recruiting
Dallas, Texas, United States
Canada, Quebec
Recruiting
Montreal, Quebec, Canada
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01979016     History of Changes
Other Study ID Numbers: R668-AD-1307
Study First Received: November 1, 2013
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 19, 2014