A Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of 2 Doses of S-777469 in Patients With Atopic Dermatitis

Completed · Phase 2 · Has a placebo group

Conditions studied: Atopic Dermatitis

In brief

The purpose of this study is to evaluate the safety and efficacy of 2 doses of S-777469 in patients with atopic dermatitis.

Key facts

Study ID

NCT00703573

Run by

Shionogi

People needed

209

Starts

2008-05-01

Expected to finish

2009-12-01

Last updated by the study team

2018-05-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients satisfying any of the following exclusion criteria are not eligible for enrollment into the double-blind treatment period:
• Patient is under the age of legal consent, is mentally or legally incapacitated and/or has significant emotional problems at the time of study entry
• Patient has an active dermatologic condition other than AD which may confound the diagnosis or evaluation of AD, such as scabies, allergic contact dermatitis, seborrheic dermatitis, cutaneous lymphoma, or psoriasis
• Patient has a history of malignancy not in remission for >5 years, with the exception of cutaneous basal cell carcinoma and cutaneous squamous cell carcinoma
• Presence of comorbid conditions that would preclude participation in the study, including:
• Immune compromised state, including recent chemotherapy, immunotherapy, or organ transplant
• History or clinical manifestations of significant metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal or urological disease
• Signs and symptoms of eczema herpeticum within the preceding 12 months or cellulitis within preceding 3 months
• Positive results for HIV infection at screening
• History or clinical manifestations of significant neurological (e.g., epilepsy) or psychiatric disorders (e.g., history of suicide attempt; history of psychiatric episodes resulting in hospitalization)
• An active intercurrent infection
• History of clinically significant hypersensitivity, anaphylaxis, or allergies to any drug compound, which resulted in a severe adverse event
• Liver function tests (ALT, AST) >1.25 times the upper limit of normal at Screening. (refer to Covance Lab Manual for reference ranges) Note: Under no circumstances should a patient who did not qualify regarding liver function tests (ALT and/or AST) be re-screened and/or re-qualified
• Patient has any acute or chronic condition or prior therapy that, in the opinion of the Investigator, would limit the patient's ability to complete and/or participate in this clinical study or otherwise would make the patient unsuitable for this study
• Patient has a history of drug abuse within 1 year prior to Day 1
• Patient consumes excess amounts of alcohol, defined as exceeding an average of 14 drinks/week (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor, or any combination of them) within 2 months prior to Day -14 (beginning of single-blind period) or is unwilling to comply with the restricted use of alcohol (as defined above, no more than 14 drinks/week) from screening, throughout the study, and until study completion (follow-up visit).
• Patient uses any prohibited concomitant medications at any time during the study
• Patient is pregnant or lactating or intends to become pregnant or, in the case of a male patient, intends to father a child during the study period and for 2 weeks after the last dose of study medication
• Patient has poor peripheral venous access that may limit blood sampling for clinical laboratory or pharmacokinetic analysis
• Patient has participated in any other investigational study drug or device trial in which receipt of an investigational study drug or device occurred within 8 weeks prior to Day 1
• Prior exposure to S-777469
• Any reason which, in the opinion of the Investigator, interferes with the ability of the patient to participate in or complete the trial

Where it is running

• Study site — Hot Springs, Arkansas, United States
• Study site — Los Angeles, California, United States
• Study site — Oceanside, California, United States
• Study site — Riverside, California, United States
• Study site — Denver, Colorado, United States
• Study site — Coral Gables, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Alpharetta, Georgia, United States
• Study site — Boise, Idaho, United States
• Study site — Arlington Heights, Illinois, United States
• Study site — Evansville, Indiana, United States
• Study site — South Bend, Indiana, United States
• Study site — Fridley, Minnesota, United States
• Study site — Omaha, Nebraska, United States
• Study site — Berlin, New Jersey, United States
• Study site — Paramus, New Jersey, United States
• Study site — Stony Brook, New York, United States
• Study site — Lake Oswego, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Johnston, Rhode Island, United States
• Study site — Goodlettsville, Tennessee, United States
• Study site — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

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