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

NCT00703573 | Completed Phase 2

• 1 other identifier: 0721D1424
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 33

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.

Conditions

Atopic Dermatitis

Keywords

Atopic Dermatitis

Outcome Measures

Primary Outcomes (2)

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

  Physician's Global Assessment

  Change from baseline to 12 weeks

• 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

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

  Baseline to 12 weeks

Secondary Outcomes (2)

• 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

Study Arms (3)

Group A

EXPERIMENTAL

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

Drug: S-777469 400 mg; Drug: Placebo

Group B

EXPERIMENTAL

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

Drug: S-777469 800 mg

Group C

PLACEBO COMPARATOR

Placebo BID (four tablets of placebo BID)

Drug: Placebo

Interventions

S-777469 400 mg DRUG

S-777469 400 mg BID

Group A

S-777469 800 mg DRUG

S-777469 800 mg BID

Group B

Placebo DRUG

Placebo BID

Group A; Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Pruritis
• 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:
• Xerosis
• Ichthyosis/palmar hyperlinearity/keratosis pilaris
• Early age of onset
• Tendency toward cutaneous infections (esp. Staphylococcus aureus and Herpes simplex) /impaired cell-mediated immunity
• Tendency toward non-specific hand or foot dermatitis

You may not qualify if:

• 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).

Sponsors & Collaborators

• Shionogi: lead

Study Sites (33)

Unknown Facility

Hot Springs, Arkansas, 71913, United States

Location

Unknown Facility

Los Angeles, California, 90045, United States

Location

Unknown Facility

Oceanside, California, 92056, United States

Location

Unknown Facility

Riverside, California, 92506, United States

Location

Unknown Facility

Denver, Colorado, 80210, United States

Location

Unknown Facility

Coral Gables, Florida, 33134, United States

Location

Unknown Facility

West Palm Beach, Florida, 33401, United States

Location

Unknown Facility

Alpharetta, Georgia, 30022, United States

Location

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Boise, Idaho, 83704, United States

Location

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Arlington Heights, Illinois, 60005, United States

Location

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Evansville, Indiana, 47713, United States

Location

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South Bend, Indiana, 46617, United States

Location

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Fridley, Minnesota, 55432, United States

Location

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Omaha, Nebraska, 68144, United States

Location

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Berlin, New Jersey, 08009, United States

Location

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Paramus, New Jersey, 07652, United States

Location

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Stony Brook, New York, 11790, United States

Location

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Lake Oswego, Oregon, 97035, United States

Location

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Portland, Oregon, 97210, United States

Location

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Portland, Oregon, 97223, United States

Location

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Portland, Oregon, 973239, United States

Location

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Philadelphia, Pennsylvania, 19104, United States

Location

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Johnston, Rhode Island, 02919, United States

Location

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Goodlettsville, Tennessee, 37072, United States

Location

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Knoxville, Tennessee, 37934, United States

Location

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Austin, Texas, 78759, United States

Location

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College Station, Texas, 77845, United States

Location

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Dallas, Texas, 75230, United States

Location

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Houston, Texas, 77058, United States

Location

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San Antonio, Texas, 78229, United States

Location

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West Jordan, Utah, 84088, United States

Location

Unknown Facility

Lynchburg, Virginia, 24501, United States

Location

Unknown Facility

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

S-777469

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2008
• First Posted: June 23, 2008
• Study Start: May 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

US (33)