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CompletedNCT01259323Updated Oct 4, 2012

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

A Phase 1 interventional study of REGN668 and REGN668 in Dermatitis, sponsored by Regeneron Pharmaceuticals. Completed at 10 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-10-04.

Sponsored by Regeneron Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Dermatitis
03

In context

Dermatitis, Atopic

1,419 studies on the registry are indexed under Dermatitis, Atopic; 258 are open to participants now.

This study's enrollment of 30 is below the median of 83 across 1,125 interventional studies indexed under Dermatitis, Atopic.

Browse Dermatitis, Atopic studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Cohort 1

    Biological: REGN668

  • Experimental
    Cohort 2

    Biological: REGN668

  • Experimental
    Cohort 3

    Biological: REGN668

Interventions

  • BiologicalREGN668

    Dose 1: REGN668 or placebo

  • BiologicalREGN668

    Dose 2: REGN668 or placebo

  • BiologicalREGN668

    Dose 3: REGN668 or placebo

06

What researchers measure

Primary outcomes

  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 outcomes

  1. The secondary endpoint is to characterize PK profile of study drug REGN668 from baseline through week 12.

    Time frame: 12 weeks

07

Study locations

10 sites
  • 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
08

References and documents

Publications

  • 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. PubMed 25482871 ↗
  • 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. PubMed 25006719 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01259323
Lead sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
Responsible party
Sponsor
First posted
Dec 14, 2010
Start date
Dec 2010
Primary completion
Jul 2012
Completion
Jul 2012
Last update
Oct 4, 2012

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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