Trial record 1 of 1 for:    R668-AD-0914
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Sequential Ascending Dose Study to Assess the Safety and Tolerability of REGN668 (SAR231893) in Patients With Atopic Dermatitis

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01259323
First received: December 10, 2010
Last updated: October 2, 2012
Last verified: October 2012

December 10, 2010
October 2, 2012
December 2010
July 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01259323 on ClinicalTrials.gov Archive Site
The secondary endpoint is to characterize PK profile of study drug REGN668 from baseline through week 12. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Sequential Ascending Dose Study to Assess the Safety and Tolerability of REGN668 (SAR231893) in Patients With Atopic Dermatitis
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Dermatitis
  • Biological: REGN668
    Dose 1: REGN668 or placebo
  • Biological: REGN668
    Dose 2: REGN668 or placebo
  • Biological: REGN668
    Dose 3: REGN668 or placebo
  • Experimental: Cohort 1
    Intervention: Biological: REGN668
  • Experimental: Cohort 2
    Intervention: Biological: REGN668
  • Experimental: Cohort 3
    Intervention: Biological: REGN668
Beck LA, Thaçi 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, Suárez-Fariñas 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01259323
R668-AD-0914
Yes
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Sanofi
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
October 2012

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