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

Primary Purpose

Dermatitis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
REGN668
REGN668
REGN668
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
December 10, 2010
Last Updated
October 2, 2012
Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01259323
Brief Title
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

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Title
Cohort 2
Arm Type
Experimental
Arm Title
Cohort 3
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
REGN668
Intervention Description
Dose 1: REGN668 or placebo
Intervention Type
Biological
Intervention Name(s)
REGN668
Intervention Description
Dose 2: REGN668 or placebo
Intervention Type
Biological
Intervention Name(s)
REGN668
Intervention Description
Dose 3: REGN668 or placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
The secondary endpoint is to characterize PK profile of study drug REGN668 from baseline through week 12.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Los Angeles
State/Province
California
Country
United States
City
Riverside
State/Province
California
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Troy
State/Province
Michigan
Country
United States
City
New York
State/Province
New York
Country
United States
City
Rochester
State/Province
New York
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Philadelphia
State/Province
Pennsylvania
Country
United States
City
Dallas
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25482871
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.
Results Reference
derived
PubMed Identifier
25006719
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.
Results Reference
derived

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

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