Study to Assess the Safety of REGN668 (SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01639040
First received: July 9, 2012
Last updated: September 27, 2013
Last verified: February 2013

July 9, 2012
September 27, 2013
July 2012
December 2012   (final data collection date for primary outcome measure)
Safety [ Time Frame: Day 1 to Day 78 ] [ Designated as safety issue: Yes ]
Assessed by evaluating the incidence of AEs from day 1 to day 78
Same as current
Complete list of historical versions of study NCT01639040 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Study to Assess the Safety of REGN668 (SAR231893) Administered Concomitantly With Topical Corticosteroids (TCS) in Patients With Moderate-to-severe Atopic Dermatitis (AD)
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Assess the Safety of REGN668 Administered Concomitantly With Topical Corticosteroids to Patients With Moderate-to-Severe Atopic Dermatitis

The purpose of this study is to assess the safety of REGN668 (SAR231893) administered concomitantly with topical corticosteroids (TCS) in patients with moderate-to-severe atopic dermatitis (AD).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: REGN668 (SAR231893)
    A total of 4 doses will be administered
  • Other: Placebo
    A total of 4 doses will be administered
  • Experimental: Regimen 1
    Intervention: Drug: REGN668 (SAR231893)
  • Placebo Comparator: Regimen 2
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
31
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male and female patients aged 18 years or older
  2. Chronic AD that has been present for at least 2 years

Exclusion Criteria:

  1. Prior treatment with REGN668 (SAR231893)
  2. Hypersensitivity to corticosteroids or to any other ingredients contained by the TCS product used in the study
  3. AD lesions located on face, flexural, and genital areas
  4. Certain treatments and medical procedures, undertaken within a particular time frame prior to the baseline visit, preclude eligibility for participation in the study
  5. Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
  6. Treatment with an investigational drug within 8 weeks
  7. Known history of human immunodeficiency virus (HIV) infection
  8. Presence of certain laboratory abnormalities at the screening visit
  9. History of certain opportunistic infections or certain clinical parasite infections
  10. History of malignancy within 5 years before the baseline visit, with certain exceptions
  11. Pregnant or breast-feeding women
  12. Travel within 12 months of study start to areas endemic for parasitic infections, such as developing countries in Africa and the tropical and subtropical regions of Asia
  13. History of alcohol or drug abuse within 2 years of the screening visit
  14. Any medical or psychiatric condition which, 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 the interpretation of study results
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Hungary,   Poland
 
NCT01639040
R668-AD-1121
Yes
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Sanofi
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
February 2013

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