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

Dermatitis, Atopic Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study of JNJ-39758979 in Adult Japanese Subjects With Moderate Atopic Dermatitis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01497119
• Other study ID #: CR017455
• Secondary ID: 39758979ADM2001
• Status: Terminated
• Phase: Phase 2
• First received: December 20, 2011
• Last updated: November 30, 2015
• Start date: October 2011
• Est. completion date: February 2012

Study information

• Verified date: November 2015
• Source: Janssen Pharmaceutical K.K.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review BoardJapan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• JNJ-39758979, 300 mg
Type=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks.
• JNJ-39758979, 100 mg
Type=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks.
• Placebo
Form=tablet, route=oral use, once daily for 6 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Pharmaceutical K.K.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monitoring of clinical laboratory tests	Assessments of blood, serum, and urine as a meaure of safety	Up to approximately 14 weeks	No
Primary	The number of adverse events	As a measure of safety	Up to approximately 14 weeks	No
Primary	Monitoring of electrocardiograms	As a measure of safety	Up to approximately 14 weeks	No
Primary	Monitoring of vital signs tests	Blood pressure and pulse as a measure of safety	Up to approximately 14 weeks	No
Primary	EASI (Eczema Area and Severity Index) score	A measure of the severity and extent of atopic dermatitis	Up to approximately 14 weeks	No
Primary	Monitoring of physical examination assessments	Including height and body weight, as a measure of safety	Up to 10 weeks	No
Secondary	Investigator's Global Assessment (IGA)	A 6-point scale that ranges from 0 (clear) to 5 (very severe disease).	Up to approximately 14 weeks	No
Secondary	Pruritus Categorical Response Scale (PCRS)	A 5-point categorical response scale where the response options range from "no itching" to "extremely severe itching."	Up to approximately 14 weeks	No
Secondary	Pruritus Numeric Rating Scales (PNRS)	An 11-point (0 to 10) numeric rating scale.	Up to approximately 14 weeks	No
Secondary	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."	Up to approximately 14 weeks	No
Secondary	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").	Up to 10 weeks	No