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

History of Changes

Tracking Information

First Received Date ^ICMJE

December 10, 2010

Last Updated Date

October 2, 2012

Start Date ^ICMJE

December 2010

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01259323 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Dermatitis

Intervention ^ICMJE

Biological: REGN668
Dose 1: REGN668 or placebo
Biological: REGN668
Dose 2: REGN668 or placebo
Biological: REGN668
Dose 3: REGN668 or placebo

Study Arm (s)

Experimental: Cohort 1
Intervention: Biological: REGN668
Experimental: Cohort 2
Intervention: Biological: REGN668
Experimental: Cohort 3
Intervention: Biological: REGN668

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

July 2012

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01259323

Other Study ID Numbers ^ICMJE

R668-AD-0914

Has Data Monitoring Committee

Yes

Responsible Party

Regeneron Pharmaceuticals

Study Sponsor ^ICMJE

Regeneron Pharmaceuticals

Collaborators ^ICMJE

Sanofi

Investigators ^ICMJE

Study Director:

Clinical Trial Management

Regeneron Pharmaceuticals

Information Provided By

Regeneron Pharmaceuticals

Verification Date

October 2012

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

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