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 August 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: August 20, 2014
Last verified: August 2014

November 1, 2013
August 20, 2014
December 2013
January 2015   (final data collection date for primary outcome measure)
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]

Same as current
Complete list of historical versions of study NCT01979016 on ClinicalTrials.gov Archive Site
  • 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)
Same as current
Not Provided
Not Provided
 
Study to Determine the Safety and Effectiveness of Dupilumab (REGN668/SAR231893) for Treatment of Atopic Dermatitis (AD)
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atopic Dermatitis (AD)
  • 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
  • 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]

  • Experimental: Group A
    Intervention: Drug: dupilumab
  • Placebo Comparator: Group B
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2015
January 2015   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com
United States,   Canada
 
NCT01979016
R668-AD-1307
No
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Sanofi
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP