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
  Purpose

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).


Condition Intervention Phase
Atopic Dermatitis
Drug: REGN668 (SAR231893)
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • 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


Enrollment: 31
Study Start Date: July 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Regimen 1 Drug: REGN668 (SAR231893)
A total of 4 doses will be administered
Placebo Comparator: Regimen 2 Other: Placebo
A total of 4 doses will be administered

  Eligibility

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

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
  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: NCT01639040

Locations
Germany
Berlin, Germany
Dresden, Germany
Duelmen, Germany
Frankfurt, Germany
Gera, Germany
Langenau, Germany
Munster, Germany
Hungary
Szeged-Hungary, Hungary
Szolnok, Hungary
Poland
Gdansk, Poland
Lodz, Poland
Lublin, Poland
Warszawa, Poland
Sponsors and Collaborators
Regeneron Pharmaceuticals
Sanofi
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided by Regeneron Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01639040     History of Changes
Other Study ID Numbers: R668-AD-1121
Study First Received: July 9, 2012
Last Updated: September 27, 2013
Health Authority: Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Germany: Paul-Ehrlich-Institut

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 21, 2014