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

Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259323
• Other study ID #: R668-AD-0914
• Status: Completed
• Phase: Phase 1
• First received: December 10, 2010
• Last updated: October 2, 2012
• Start date: December 2010
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 weeks	Yes
Secondary	The secondary endpoint is to characterize PK profile of study drug REGN668 from baseline through week 12.		12 weeks	No