Clinical trial NCT01259323: Sequential Ascending Dose Study to Assess the Safety and Tolerability of REGN668 (SAR231893) in Patients With Atopic Dermatitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dermatitis
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2010-12-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
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.
timeFrame: 12 weeks
Secondary outcomes:
measure: The secondary endpoint is to characterize PK profile of study drug REGN668 from baseline through week 12.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Riverside
country: United States
state: California
city: Miami
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Troy
country: United States
state: Michigan
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Portland
country: United States
state: Oregon
city: Philadelphia
country: United States
state: Pennsylvania
city: Dallas
country: United States
state: Texas
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.