Clinical Trials/NCT00703573

NCT00703573

Completed

Phase 2

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of 2 Doses of S-777469 (400 mg BID and 800 mg BID) in Patients With Atopic Dermatitis

Shionogi0 sites209 target enrollmentMay 2008

ConditionsAtopic Dermatitis

InterventionsS-777469 400 mg Placebo S-777469 800 mg

DrugsS-777469 400 mg S-777469 800 mg Placebo

Overview

Phase: Phase 2
Intervention: S-777469 400 mg
Conditions: Atopic Dermatitis
Sponsor: Shionogi
Enrollment: 209
Primary Endpoint: Efficacy of S-777469 was assessed by Physician's Global Assessment (PGA) and Numerical Rating Scale (NRS)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

May 2008

End Date

December 2009

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shionogi

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Each patient must meet all of the following inclusion criteria to be screened and enrolled into the single-blind period:
•Males or females between 18 and 65 years of age at the time of obtaining the written informed consent
•Patient understands the study procedures and agrees to participate in the study by giving written informed consent
•Patient agrees to allow digital photographs of atopic dermatitis (AD)-affected target areas during the study
•Patient satisfies the diagnostic criteria for AD as defined by the criteria of Hanifin and Rajka (Acta Derm Venereol.1980;92\[suppl\]:44-47; J Am Acad Dermatol.2003;49\[6\]:1088-1095), as follows:
•Must have 3 or more basic features:
•Typical morphology and distribution: flexural lichenification or linearity
•Chronic or chronically relapsing dermatitis
•Personal or family history of atopy (asthma, allergic rhinitis, atopic dermatitis)
•Plus 3 or more minor features:

Exclusion Criteria

•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)

Arms & Interventions

Group A

S-777469 400 mg BID (two 200 mg tablets of S-777469 and two tablets of placebo BID)

Intervention: S-777469 400 mg

Group A

S-777469 400 mg BID (two 200 mg tablets of S-777469 and two tablets of placebo BID)

Intervention: Placebo

Group B

S-777469 800 mg BID (four 200 mg tablets of S-777469 BID)

Intervention: S-777469 800 mg

Group C

Placebo BID (four tablets of placebo BID)

Intervention: Placebo

Outcomes

Primary Outcomes

Efficacy of S-777469 was assessed by Physician's Global Assessment (PGA) and Numerical Rating Scale (NRS)

Time Frame: Change from baseline to 12 weeks

Physician's Global Assessment

Safety was assessed by repeated clinical evaluation and evaluation of treatment-emergent adverse events. It included vital signs, medical history, concomitant medications, physical examination, 12-lead ECGs, and standard clinical laboratory safety tests

Time Frame: Baseline to 12 weeks

Safety, determined by Adverse event frequency and changes in laboratory values

Secondary Outcomes

Efficacy was assessed by PGA, NRS, Behavioral Rating Scale, Eczema Area and Severity Index Score, Investigator panel treatment-blind comparative review ratings of digital photography of affected areas, and Thymus and Activation-Regulated Chemokine(Changes from baseline to various pre-defined time-points during the 12 week study)
Pharmacokinetic analysis of the concentration of unchanged parent drug (S-777469) in trough samples(From Baseline during Week 1)