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Sequential Ascending Dose Study to Assess the Safety and Tolerability of REGN668 (SAR231893) in Patients With Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01259323
Recruitment Status : Completed
First Posted : December 14, 2010
Last Update Posted : October 4, 2012
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

Brief Summary:
The purpose of this study is to assess the Safety and Tolerability of REGN668 (how the body reacts to the drug) compared to placebo (an inert substance) in patients with moderate-to-severe extrinsic Atopic Dermatitis.

Condition or disease Intervention/treatment Phase
Dermatitis Biological: REGN668 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending, Repeated-Dose Study of the Safety and Pharmacokinetics of Subcutaneous REGN668 in Patients With Moderate-to-Severe Extrinsic Atopic Dermatitis
Study Start Date : December 2010
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: Cohort 1 Biological: REGN668
Dose 1: REGN668 or placebo

Experimental: Cohort 2 Biological: REGN668
Dose 2: REGN668 or placebo

Experimental: Cohort 3 Biological: REGN668
Dose 3: REGN668 or placebo

Primary Outcome Measures :
  1. The primary endpoint in the study is the incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN668 or Placebo from baseline through week 12. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The secondary endpoint is to characterize PK profile of study drug REGN668 from baseline through week 12. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of atopic dermatitis that has been present for at least 3 years before the screening visit
  • Investigator's Global Assessment (IGA) score of >/= 3 at the screening and baseline visits
  • >/= 15% body surface area (BSA) of AD involvement at the screening and baseline visits
  • History of inadequate response to a stable (>/= 1 month) regimen of topical corticosteroids or calcineurin inhibitors as treatment for AD within 3 months before the screening visit
  • Willing and able to comply with clinic visits and study-related procedures
  • Patient able to read and understand, and willing to sign the informed consent form

Exclusion Criteria:

  • A positive QuantiFERON® - TB (tuberculosis) Gold Test at the screening visit
  • Known history of Human Immunodeficiency Virus (HIV), Hepatitis B or Hepatitis C and/or positive Hepatitis B surface antigen (HBsAg), positive Hepatitis C antibody (HCV)
  • Treatment with an investigational drug within 8 weeks before the baseline visit
  • Treatment with leukotriene inhibitors within 4 weeks before the baseline visit
  • Treatment with systemic corticosteroids within 4 weeks before the baseline visit
  • Treatment with topical corticosteroids, tacrolimus, and/or pimecrolimus within 1 week before the baseline visit
  • Systemic treatment for AD with an immunosuppressive/immunomodulating substance within 4 weeks before the baseline visit
  • Chronic or acute infection requiring treatment
  • History of clinical parasite infection, other than treated trichomoniasis
  • History of malignancy within 5 years before the baseline visit
  • 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
  • Pregnant or breast-feeding women
  • Unwilling to use adequate birth control, if of reproductive potential and sexually active

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01259323

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United States, California
Los Angeles, California, United States
Riverside, California, United States
United States, Florida
Miami, Florida, United States
United States, Illinois
Chicago, Illinois, United States
United States, Michigan
Troy, Michigan, United States
United States, New York
New York, New York, United States
Rochester, New York, United States
United States, Oregon
Portland, Oregon, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
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Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Regeneron Pharmaceuticals Identifier: NCT01259323    
Other Study ID Numbers: R668-AD-0914
First Posted: December 14, 2010    Key Record Dates
Last Update Posted: October 4, 2012
Last Verified: October 2012
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs