A Study of JNJ-39758979 in Adult Japanese Patients With Moderate Atopic Dermatitis

NCT01497119 | Terminated Phase 2

• 2 other identifiers: CR01745539758979ADM2001
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy of JNJ-39758979 in adult Japanese patients with moderate, active atopic dermatitis.

Conditions

Dermatitis, Atopic

Keywords

Moderate atopic dermatitis; JNJ-39758979; Japanese patients

Outcome Measures

Primary Outcomes (6)

• Monitoring of clinical laboratory tests

  Assessments of blood, serum, and urine as a meaure of safety

  Up to approximately 14 weeks

• The number of adverse events

  As a measure of safety

  Up to approximately 14 weeks

• Monitoring of electrocardiograms

  As a measure of safety

  Up to approximately 14 weeks

• Monitoring of vital signs tests

  Blood pressure and pulse as a measure of safety

  Up to approximately 14 weeks

• EASI (Eczema Area and Severity Index) score

  A measure of the severity and extent of atopic dermatitis

  Up to approximately 14 weeks

• Monitoring of physical examination assessments

  Including height and body weight, as a measure of safety

  Up to 10 weeks

Secondary Outcomes (5)

• Investigator's Global Assessment (IGA)

  Up to approximately 14 weeks

• Pruritus Categorical Response Scale (PCRS)

  Up to approximately 14 weeks

• Pruritus Numeric Rating Scales (PNRS)

  Up to approximately 14 weeks

• Pruritus Interference Numeric Rating Scale (PINRS)

  Up to approximately 14 weeks

• Subject's Global Impressions of Change in Pruritus (SGICP)

  Up to 10 weeks

Study Arms (3)

JNJ-39758979, 300 mg

EXPERIMENTAL

Drug: JNJ-39758979, 300 mg

JNJ-39758979, 100 mg

EXPERIMENTAL

Drug: JNJ-39758979, 100 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

JNJ-39758979, 300 mg DRUG

Type=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks.

JNJ-39758979, 300 mg

JNJ-39758979, 100 mg DRUG

Type=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks.

JNJ-39758979, 100 mg

Placebo DRUG

Form=tablet, route=oral use, once daily for 6 weeks.

Placebo

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of atopic dermatitis based on the criteria of the Japanese Dermatological Association and have: pruritus (itching); eczema-like changes in a typical pattern, and a chronic or chronically relapsing course.
• Childhood onset (under age of 13) of atopic dermatitis.
• Diagnosis of moderate atopic dermatitis based on the Rajka Langeland score between 4.5 and 7.5, inclusive.
• Have at least 3 ratings of "Moderate itching", "Severe itching", or "Extremely severe itching" either at night or during the day based on the Pruritus Categorical Response Scale (PCRS) in the 7 days prior to randomization.
• Atopic dermatitis with 10% to 50% (inclusive) Body Surface Area (BSA) involvement.

You may not qualify if:

• Have current signs or symptoms of liver or renal insufficiency or cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, psychiatric, or metabolic disturbances that are severe, progressive or uncontrolled in the Investigator's opinion. Patients with well controlled asthma, allergic rhinitis, or allergic conjunctivitis are allowed to participate. Atopic dermatitis patients with other chronic conditions will not be excluded if the Investigator has determined that the condition is not severe or progressive and is being controlled with stable therapy.
• Have any known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent).
• Evidence of any other skin condition that, in the opinion of the Investigator, would interfere with the assessment of atopic dermatitis.
• Use of non-steroid immunosuppressive or immunomodulatory agents within 4 weeks of randomization, including cyclosporine A, azathioprine, mycophenolate mofetil, and interferon gamma.
• Use of systemic corticosteroids within 4 weeks of randomization.

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (13)

Unknown Facility

Chitose, Japan

Location

Unknown Facility

Dazaifu, Japan

Location

Unknown Facility

Ebetsu, Japan

Location

Unknown Facility

Eniwa, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Kasuga, Japan

Location

Unknown Facility

Matsudo, Japan

Location

Unknown Facility

Saitama, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Setagaya City, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Utsunomiya, Japan

Location

Unknown Facility

Yokohama, Japan

Location

MeSH Terms

Conditions

Dermatitis, Atopic

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

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  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: December 20, 2011
• First Posted: December 22, 2011
• Study Start: October 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: December 2, 2015

Record last verified: 2015-11

Locations

JP (13)