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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01497119
Recruitment Status : Terminated (This study was terminated prematurely due to 2 cases of agranulocytosis.)
First Posted : December 22, 2011
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Tracking Information
First Submitted Date  ICMJE December 20, 2011
First Posted Date  ICMJE December 22, 2011
Last Update Posted Date December 2, 2015
Study Start Date  ICMJE October 2011
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2012)
  • Monitoring of clinical laboratory tests [ Time Frame: Up to approximately 14 weeks ]
    Assessments of blood, serum, and urine as a meaure of safety
  • The number of adverse events [ Time Frame: Up to approximately 14 weeks ]
    As a measure of safety
  • Monitoring of electrocardiograms [ Time Frame: Up to approximately 14 weeks ]
    As a measure of safety
  • Monitoring of vital signs tests [ Time Frame: Up to approximately 14 weeks ]
    Blood pressure and pulse as a measure of safety
  • EASI (Eczema Area and Severity Index) score [ Time Frame: Up to approximately 14 weeks ]
    A measure of the severity and extent of atopic dermatitis
  • Monitoring of physical examination assessments [ Time Frame: Up to 10 weeks ]
    Including height and body weight, as a measure of safety
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2011)
  • Changes in clinical laboratory tests [ Time Frame: Up to approximately 14 weeks ]
    Assessments of blood, serum, and urine
  • The number of adverse events [ Time Frame: Up to approximately 14 weeks ]
  • Changes in electrocardiograms [ Time Frame: Up to approximately 14 weeks ]
  • Changes in vital signs [ Time Frame: Up to approximately 14 weeks ]
    Blood pressure and pulse
  • Change in EASI (Eczema Area and Severity Index) score [ Time Frame: Up to approximately 14 weeks ]
    A measure of the severity and extent of atopic dermatitis
  • Changes in physical examination evaluations [ Time Frame: Up to 10 weeks ]
    Including height and body weight
Change History Complete list of historical versions of study NCT01497119 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2011)
  • Investigator's Global Assessment (IGA) [ Time Frame: Up to approximately 14 weeks ]
    A 6-point scale that ranges from 0 (clear) to 5 (very severe disease).
  • Pruritus Categorical Response Scale (PCRS) [ Time Frame: Up to approximately 14 weeks ]
    A 5-point categorical response scale where the response options range from "no itching" to "extremely severe itching."
  • Pruritus Numeric Rating Scales (PNRS) [ Time Frame: Up to approximately 14 weeks ]
    An 11-point (0 to 10) numeric rating scale.
  • Pruritus Interference Numeric Rating Scale (PINRS) [ Time Frame: Up to approximately 14 weeks ]
    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) [ Time Frame: Up to 10 weeks ]
    A 7-point scale ranging from "a lot more now" to " a lot less now" with a neutral center point ("neither more nor less").
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of JNJ-39758979 in Adult Japanese Patients With Moderate Atopic Dermatitis
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-39758979 in Adult Japanese Subjects With Moderate Atopic Dermatitis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dermatitis, Atopic
Intervention  ICMJE
  • Drug: JNJ-39758979, 300 mg
    Type=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks.
  • Drug: JNJ-39758979, 100 mg
    Type=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks.
  • Drug: Placebo
    Form=tablet, route=oral use, once daily for 6 weeks.
Study Arms  ICMJE
  • Experimental: JNJ-39758979, 300 mg
    Intervention: Drug: JNJ-39758979, 300 mg
  • Experimental: JNJ-39758979, 100 mg
    Intervention: Drug: JNJ-39758979, 100 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 16, 2012)
88
Original Estimated Enrollment  ICMJE
 (submitted: December 20, 2011)
105
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01497119
Other Study ID Numbers  ICMJE CR017455
39758979ADM2001 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Pharmaceutical K.K.
Study Sponsor  ICMJE Janssen Pharmaceutical K.K.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
PRS Account Janssen Pharmaceutical K.K.
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP