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

October 2, 2012 updated by: Regeneron Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States
      • Riverside, California, United States
    • Florida
      • Miami, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Michigan
      • Troy, Michigan, United States
    • New York
      • New York, New York, United States
      • Rochester, New York, United States
    • Oregon
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • Texas
      • Dallas, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Biological: REGN668
Dose 1: REGN668 or placebo
Biological: REGN668
Dose 2: REGN668 or placebo
Biological: REGN668
Dose 3: REGN668 or placebo
Experimental: Cohort 2
Biological: REGN668
Dose 1: REGN668 or placebo
Biological: REGN668
Dose 2: REGN668 or placebo
Biological: REGN668
Dose 3: REGN668 or placebo
Experimental: Cohort 3
Biological: REGN668
Dose 1: REGN668 or placebo
Biological: REGN668
Dose 2: REGN668 or placebo
Biological: REGN668
Dose 3: REGN668 or placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary endpoint is to characterize PK profile of study drug REGN668 from baseline through week 12.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Collaborators

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

December 10, 2010

First Submitted That Met QC Criteria

December 10, 2010

First Posted (Estimate)

December 14, 2010

Study Record Updates

Last Update Posted (Estimate)

October 4, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R668-AD-0914

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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