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Trial record 1 of 1 for:    NCT01497119
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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. 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
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Atopic Drug: JNJ-39758979, 300 mg Drug: JNJ-39758979, 100 mg Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-39758979 in Adult Japanese Subjects With Moderate Atopic Dermatitis
Study Start Date : October 2011
Actual Primary Completion Date : February 2012
Actual Study Completion Date : February 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: JNJ-39758979, 300 mg Drug: JNJ-39758979, 300 mg
Type=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks.

Experimental: JNJ-39758979, 100 mg Drug: JNJ-39758979, 100 mg
Type=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks.

Placebo Comparator: Placebo Drug: Placebo
Form=tablet, route=oral use, once daily for 6 weeks.

Primary Outcome Measures :
  1. Monitoring of clinical laboratory tests [ Time Frame: Up to approximately 14 weeks ]
    Assessments of blood, serum, and urine as a meaure of safety

  2. The number of adverse events [ Time Frame: Up to approximately 14 weeks ]
    As a measure of safety

  3. Monitoring of electrocardiograms [ Time Frame: Up to approximately 14 weeks ]
    As a measure of safety

  4. Monitoring of vital signs tests [ Time Frame: Up to approximately 14 weeks ]
    Blood pressure and pulse as a measure of safety

  5. EASI (Eczema Area and Severity Index) score [ Time Frame: Up to approximately 14 weeks ]
    A measure of the severity and extent of atopic dermatitis

  6. Monitoring of physical examination assessments [ Time Frame: Up to 10 weeks ]
    Including height and body weight, as a measure of safety

Secondary Outcome Measures :
  1. 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).

  2. 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."

  3. Pruritus Numeric Rating Scales (PNRS) [ Time Frame: Up to approximately 14 weeks ]
    An 11-point (0 to 10) numeric rating scale.

  4. 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."

  5. 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").

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01497119

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Chitose, Japan
Dazaifu, Japan
Ebetsu, Japan
Eniwa, Japan
Fukuoka, Japan
Kasuga, Japan
Matsudo, Japan
Saitama, Japan
Sapporo, Japan
Setagaya, Japan
Tokyo, Japan
Utsunomiya, Japan
Yokohama, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
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Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.

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Responsible Party: Janssen Pharmaceutical K.K. Identifier: NCT01497119    
Other Study ID Numbers: CR017455
39758979ADM2001 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Posted: December 22, 2011    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015
Keywords provided by Janssen Pharmaceutical K.K.:
Moderate atopic dermatitis
Japanese patients
Additional relevant MeSH terms:
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Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases