Official Title: “A Phase 1/2 Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study to Evaluate the Safety of Repeated Topical Application of Three Concentrations of NF-kappaB Decoy in Adults With Mild-to-Moderate Atopic Dermatitis”

The purpose of this study is to determine whether this topical NF-kappaB Decoy candidate is safe in persons with atopic dermatitis. Preliminary evidence of efficacy (whether it is working) will also be evaluated.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

This is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study to evaluate the safety of repeated application of three concentrations of NF-kappaB Decoy in approximately 75 subjects with mild-to-moderate atopic dermatitis. The face, hands, feet, scalp, or groin may NOT be treated.

Other treatment agents are currently available for atopic dermatitis but present significant potential side effects (topical steroids) or are potent immunosuppressives (topical calcineurin inhibitors) with pending longer-term safety data.

NF-kappaB Decoy is a double-stranded deoxyribonucleic acid (DNA) oligodeoxynucleotide that mimics the NF-kappaB binding sequence on the chromosomal DNA, thereby inhibiting the production of the inflammatory response triggered by NF-kappaB. This mechanism of action presents a unique treatment modality.

A comprehensive series of nonclinical data have produced promising results.

Primary:

• To evaluate the safety and tolerability of twice-daily topical application of three concentrations of NF-kappaB Decoy in adult subjects with mild-to-moderate atopic dermatitis

Secondary:

• To make a preliminary evaluation of the efficacy of the topical NF-kappaB Decoy in the treatment of mild-to-moderate atopic dermatitis in adult subjects
• To evaluate the systemic pharmacokinetic (PK) profile of NF-kappaB Decoy

Inclusion Criteria:

• Are 18 through 65 years of age and sign an informed consent
• Have been given a diagnosis of mild to moderate atopic dermatitis as defined by:
• *Pruritus; *Eczematous dermatitis (acute, subacute, chronic) involving at least current or prior flexural lesions with chronic or relapsing course; *Early age of onset (prior to 10 years of age, by history); *Personal or family history of atopy
• If receiving antihistamines, are on a stabilized dose, and expect to maintain this dose throughout the study
• Are females or males of reproductive potential who are compliant in using adequate birth control or are females or males not of reproductive potential

Exclusion Criteria:

• Have concomitant dermatologic or medical condition(s) which may interfere with the investigator’s ability to evaluate the subject’s response to the study drug
• Have immunocompromised status (such as known human immunodeficiency virus infection)
• Have any clinically significant abnormal clinical laboratory test results at
• Screening
• Have a history of malignancy not in remission for at least 5 years excluding basal cell carcinoma and nonperiorificial squamous cell carcinoma of the skin
• Have an active intercurrent infection
• Have applied any topical medication (including corticosteroid, calcineurin inhibitor, topical H1 and H2 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment within 1 week of the Day 1 visit; have used any systemic antibiotic within 1 week prior to the Day 1 visit;
• have used any systemic treatment for atopic dermatitis (including systemic corticosteroids, nonsteroidal immunosuppressants, or treatment with light) within 4 weeks prior to the Day 1 visit; have used an investigational drug for any reason within 4 weeks of the Day 1 visit; have used intranasal and/or inhaled corticosteroids at doses > 2 mg prednisone or equivalent per day within 4 weeks of the Day 1 visit; or have used immunosuppressive or immunomodulating drugs such as etanercept, alefacept, or infliximab within 16 weeks prior to Day 1
• Have a history of hypersensitivity or allergic reactions to parabens or any other ingredient in the vehicle formulation
• If female, are pregnant or lactating, or intend to become pregnant during the study period
• If male, have a female partner who is pregnant or lactating, or intends to become pregnant during the study period
• Have any reason which, in the opinion of the investigator, interferes with the ability of the subject to participate in or complete the trial, or which places the subject at undue risk

Lead Sponsor: Anesiva, Inc.

University of Miami Skin Research

Miami Florida 33136 United States

Minnesota Clinical Study Center

Fridley Minnesota 55432 United States

Helendale Dermatology & Medical Spa, LLP

Rochester New York 14609 United States

Mount Sinai School of Medicine

New York New York 10029 United States

Oregon Health & Science University, Department of Dermatology

Portland Oregon 97201 United States

Derm Research, Inc.

Austin Texas 78759 United States

Center for Clinical Studies

Houston Texas 77030 United States

Center for Clinical Studies

South Houston Texas 77058 United States

Madison Skin & Research, Inc.

Madison Wisconsin 53719 United States

Overall Clinical Trial Officials and Contacts

Andria Langenberg, MD Study Director Anesiva, Inc.  

Information obtained from ClinicalTrials.gov on July 23, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00125333

Study ID Number: 110-01P

ClinicalTrials.gov Identifier: NCT00125333

Health Authority: United States: Food and Drug Administration