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

Regeneron Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Dermatitis

Treatments

Biological: REGN668

Study type

Interventional

Funder types

Industry

Identifiers

NCT01259323

R668-AD-0914

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No 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