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
  Purpose

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


Condition Intervention Phase
Atopic Dermatitis
Drug: dupilumab (REGN668/ SAR231893)
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, Dose-Ranging Study Investigating the Efficacy, Safety, Pharmacokinetic and Biomarker Profiles of REGN668 Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis

Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 380
Study Start Date: May 2013
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1
dose regimen 1
Drug: dupilumab (REGN668/ SAR231893)
Experimental: Group 2
dose regimen 2
Drug: dupilumab (REGN668/ SAR231893)
Experimental: Group 3
dose regimen 3
Drug: dupilumab (REGN668/ SAR231893)
Experimental: Group 4
dose regimen 4
Drug: dupilumab (REGN668/ SAR231893)
Experimental: Group 5
dose regimen 5
Drug: dupilumab (REGN668/ SAR231893)
Placebo Comparator: Group 6
dose regimen 6
Drug: placebo

  Eligibility

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

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
  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: NCT01859988

  Show 84 Study Locations
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: NCT01859988     History of Changes
Other Study ID Numbers: R668-AD-1021
Study First Received: May 20, 2013
Last Updated: January 23, 2014
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Canada: Health Canada
Germany: Paul-Ehrlich-Institut
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Japan: Pharmaceuticals and Medical Devices Agency

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 July 28, 2014