Back to resultsA Study of JNJ-39758979 in Adult Japanese Patients With Moderate Atopic Dermatitis
Primary Purpose
Dermatitis, Atopic
Status
Terminated
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
JNJ-39758979, 300 mg
JNJ-39758979, 100 mg
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Moderate atopic dermatitis, JNJ-39758979, Japanese patients
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
JNJ-39758979, 300 mg
JNJ-39758979, 100 mg
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Monitoring of clinical laboratory tests
Assessments of blood, serum, and urine as a meaure of safety
The number of adverse events
As a measure of safety
Monitoring of electrocardiograms
As a measure of safety
Monitoring of vital signs tests
Blood pressure and pulse as a measure of safety
EASI (Eczema Area and Severity Index) score
A measure of the severity and extent of atopic dermatitis
Monitoring of physical examination assessments
Including height and body weight, as a measure of safety
Secondary Outcome Measures
Investigator's Global Assessment (IGA)
A 6-point scale that ranges from 0 (clear) to 5 (very severe disease).
Pruritus Categorical Response Scale (PCRS)
A 5-point categorical response scale where the response options range from "no itching" to "extremely severe itching."
Pruritus Numeric Rating Scales (PNRS)
An 11-point (0 to 10) numeric rating scale.
Pruritus Interference Numeric Rating Scale (PINRS)
An 11-point numerical rating scale of 0 to 10, where 0 = "Did Not Interfere" and 10 = "Completely Interfered."
Subject's Global Impressions of Change in Pruritus (SGICP)
A 7-point scale ranging from "a lot more now" to " a lot less now" with a neutral center point ("neither more nor less").
Full Information
NCT ID
NCT01497119
First Posted
December 20, 2011
Last Updated
November 30, 2015
Sponsor
Janssen Pharmaceutical K.K.
1. Study Identification
Unique Protocol Identification Number
NCT01497119
Brief Title
A Study of JNJ-39758979 in Adult Japanese Patients With Moderate Atopic Dermatitis
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-39758979 in Adult Japanese Subjects With Moderate Atopic Dermatitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated prematurely due to 2 cases of agranulocytosis.
Study Start Date
October 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
February 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Pharmaceutical K.K.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This is a randomized (treatment assigned by chance), double-blind (patient and investigator will not know what treatment is being given), multicenter, parallel-group, exploratory study in adult Japanese patients with moderate atopic dermatitis. This study will include 3 phases. In the screening phase, patients' eligibility will be determined. During the treatment phase, eligible patients will receive JNJ-39758979, 300 or 100 mg once daily, or placebo (a treatment that looks like JNJ-39758979, but contains no active agent) for up to 6 weeks. Study visits will occur at the end of Weeks 1, 2, 4, and 6. There will be a follow-up visit 4 weeks after dosing is complete. The duration of participation in the study for an individual patient may be up to 14 weeks (including screening). Patient safety will be monitored throughout the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Atopic
Keywords
Moderate atopic dermatitis, JNJ-39758979, Japanese patients
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JNJ-39758979, 300 mg
Arm Type
Experimental
Arm Title
JNJ-39758979, 100 mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
JNJ-39758979, 300 mg
Intervention Description
Type=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
JNJ-39758979, 100 mg
Intervention Description
Type=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Form=tablet, route=oral use, once daily for 6 weeks.
Primary Outcome Measure Information:
Title
Monitoring of clinical laboratory tests
Description
Assessments of blood, serum, and urine as a meaure of safety
Time Frame
Up to approximately 14 weeks
Title
The number of adverse events
Description
As a measure of safety
Time Frame
Up to approximately 14 weeks
Title
Monitoring of electrocardiograms
Description
As a measure of safety
Time Frame
Up to approximately 14 weeks
Title
Monitoring of vital signs tests
Description
Blood pressure and pulse as a measure of safety
Time Frame
Up to approximately 14 weeks
Title
EASI (Eczema Area and Severity Index) score
Description
A measure of the severity and extent of atopic dermatitis
Time Frame
Up to approximately 14 weeks
Title
Monitoring of physical examination assessments
Description
Including height and body weight, as a measure of safety
Time Frame
Up to 10 weeks
Secondary Outcome Measure Information:
Title
Investigator's Global Assessment (IGA)
Description
A 6-point scale that ranges from 0 (clear) to 5 (very severe disease).
Time Frame
Up to approximately 14 weeks
Title
Pruritus Categorical Response Scale (PCRS)
Description
A 5-point categorical response scale where the response options range from "no itching" to "extremely severe itching."
Time Frame
Up to approximately 14 weeks
Title
Pruritus Numeric Rating Scales (PNRS)
Description
An 11-point (0 to 10) numeric rating scale.
Time Frame
Up to approximately 14 weeks
Title
Pruritus Interference Numeric Rating Scale (PINRS)
Description
An 11-point numerical rating scale of 0 to 10, where 0 = "Did Not Interfere" and 10 = "Completely Interfered."
Time Frame
Up to approximately 14 weeks
Title
Subject's Global Impressions of Change in Pruritus (SGICP)
Description
A 7-point scale ranging from "a lot more now" to " a lot less now" with a neutral center point ("neither more nor less").
Time Frame
Up to 10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Pharmaceutical K.K., Japan Clinical Trial
Organizational Affiliation
Janssen Pharmaceutical K.K.
Official's Role
Study Director
Facility Information:
City
Chitose
Country
Japan
City
Dazaifu
Country
Japan
City
Ebetsu
Country
Japan
City
Eniwa
Country
Japan
City
Fukuoka
Country
Japan
City
Kasuga
Country
Japan
City
Matsudo
Country
Japan
City
Saitama
Country
Japan
City
Sapporo
Country
Japan
City
Setagaya
Country
Japan
City
Tokyo
Country
Japan
City
Utsunomiya
Country
Japan
City
Yokohama
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Study of JNJ-39758979 in Adult Japanese Patients With Moderate Atopic Dermatitis
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