Study of Dupilumab (REGN668/ SAR231893) Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01859988
First received: May 20, 2013
Last updated: January 23, 2014
Last verified: January 2014

May 20, 2013
January 23, 2014
May 2013
June 2014   (final data collection date for primary outcome measure)
Percent change in Eczema Area and Severity Index score [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
Percent change in Eczema Area and Severity Index (EASI) score from baseline to week 16.
Same as current
Complete list of historical versions of study NCT01859988 on ClinicalTrials.gov Archive Site
  • Investigator's Global Assessment score [ Time Frame: At week 16 ] [ Designated as safety issue: No ]
    Proportion of participants achieving Investigator's Global Assessment (IGA) score 0 (clear) or 1 (almost clear) at week 16
  • Absolute change in EASI score [ Time Frame: Baseline to week 16 ] [ Designated as safety issue: No ]
    Absolute change in EASI scores from baseline to week 16
Same as current
Not Provided
Not Provided
 
Study of Dupilumab (REGN668/ SAR231893) Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of REGN668 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

To assess the efficacy of multiple dupilumab (REGN668/ SAR231893) dose-regimens, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).

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
  • Drug: dupilumab (REGN668/ SAR231893)
  • Drug: placebo
  • Experimental: Group 1
    dose regimen 1
    Intervention: Drug: dupilumab (REGN668/ SAR231893)
  • Experimental: Group 2
    dose regimen 2
    Intervention: Drug: dupilumab (REGN668/ SAR231893)
  • Experimental: Group 3
    dose regimen 3
    Intervention: Drug: dupilumab (REGN668/ SAR231893)
  • Experimental: Group 4
    dose regimen 4
    Intervention: Drug: dupilumab (REGN668/ SAR231893)
  • Experimental: Group 5
    dose regimen 5
    Intervention: Drug: dupilumab (REGN668/ SAR231893)
  • Placebo Comparator: Group 6
    dose regimen 6
    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.
 
Active, not recruiting
380
September 2014
June 2014   (final data collection date for primary outcome measure)

The inclusion criteria include, but are not limited to, the following:

  1. Chronic Atopic Dermatitis that has been present for at least 3 years
  2. History of inadequate response to outpatient treatment with topical medications, or for whom topical treatments are otherwise inadvisable (eg, because of important side effects or safety risks)
  3. Willing and able to comply with all clinic visits and study-related procedures

The exclusion criteria include, but are not limited to, the following:

  1. Prior treatment with dupilumab (REGN668/ SAR231893)
  2. Presence of certain laboratory abnormalities at the screening visit
  3. Treatment with an investigational drug within 8 weeks of baseline visit
  4. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
  5. Certain other treatments and medical procedures undertaken within a particular timeframe prior to the baseline visit
  6. Known history of human immunodeficiency virus (HIV) infection
  7. History of malignancy within 5 years before the baseline visit (with certain exceptions)
  8. Planned surgical procedure during the length of the study
  9. High risk of parasite infection
  10. Any other medical or psychological condition that, in the opinion of the investigator or the sponsor's medical monitor, would place the patient at risk, interfere with participation in the study or interfere with interpretation of study results.
  11. Pregnant or breast-feeding women
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Czech Republic,   Germany,   Hungary,   Japan,   Poland
 
NCT01859988
R668-AD-1021
No
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Sanofi
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
January 2014

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