Sequential Ascending Dose Study to Assess the Safety and Tolerability of REGN668 (SAR231893) in Patients With Atopic Dermatitis
NCT ID: NCT01259323
Last Updated: 2012-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
30 participants
INTERVENTIONAL
2010-12-31
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1
REGN668
Dose 1: REGN668 or placebo
Cohort 2
REGN668
Dose 2: REGN668 or placebo
Cohort 3
REGN668
Dose 3: REGN668 or placebo
Interventions
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REGN668
Dose 1: REGN668 or placebo
REGN668
Dose 2: REGN668 or placebo
REGN668
Dose 3: REGN668 or placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Los Angeles, California, United States
Riverside, California, United States
Miami, Florida, United States
Chicago, Illinois, United States
Troy, Michigan, United States
New York, New York, United States
Rochester, New York, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Countries
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References
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Hamilton JD, Suarez-Farinas M, Dhingra N, Cardinale I, Li X, Kostic A, Ming JE, Radin AR, Krueger JG, Graham N, Yancopoulos GD, Pirozzi G, Guttman-Yassky E. Dupilumab improves the molecular signature in skin of patients with moderate-to-severe atopic dermatitis. J Allergy Clin Immunol. 2014 Dec;134(6):1293-1300. doi: 10.1016/j.jaci.2014.10.013.
Beck LA, Thaci D, Hamilton JD, Graham NM, Bieber T, Rocklin R, Ming JE, Ren H, Kao R, Simpson E, Ardeleanu M, Weinstein SP, Pirozzi G, Guttman-Yassky E, Suarez-Farinas M, Hager MD, Stahl N, Yancopoulos GD, Radin AR. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. N Engl J Med. 2014 Jul 10;371(2):130-9. doi: 10.1056/NEJMoa1314768.
Other Identifiers
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R668-AD-0914
Identifier Type: -
Identifier Source: org_study_id