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

This study has been terminated.
(This study was terminated prematurely due to 2 cases of agranulocytosis.)
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01497119
First received: December 20, 2011
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Dermatitis, Atopic
Drug: JNJ-39758979, 300 mg
Drug: JNJ-39758979, 100 mg
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Monitoring of clinical laboratory tests [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
    Assessments of blood, serum, and urine as a meaure of safety

  • The number of adverse events [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
    As a measure of safety

  • Monitoring of electrocardiograms [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
    As a measure of safety

  • Monitoring of vital signs tests [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
    Blood pressure and pulse as a measure of safety

  • EASI (Eczema Area and Severity Index) score [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
    A measure of the severity and extent of atopic dermatitis

  • Monitoring of physical examination assessments [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: No ]
    Including height and body weight, as a measure of safety


Secondary Outcome Measures:
  • Investigator's Global Assessment (IGA) [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    An 11-point (0 to 10) numeric rating scale.

  • Pruritus Interference Numeric Rating Scale (PINRS) [ Time Frame: Up to approximately 14 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    A 7-point scale ranging from "a lot more now" to " a lot less now" with a neutral center point ("neither more nor less").


Enrollment: 88
Study Start Date: October 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01497119

Locations
Japan
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.
Investigators
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01497119     History of Changes
Other Study ID Numbers: CR017455, 39758979ADM2001
Study First Received: December 20, 2011
Last Updated: March 1, 2013
Health Authority: Japan: Institutional Review Board

Keywords provided by Janssen Pharmaceutical K.K.:
Moderate atopic dermatitis
JNJ-39758979
Japanese patients

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic

ClinicalTrials.gov processed this record on October 29, 2014