An Efficacy and Safety Study of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis

This study has been terminated.
(The study was stopped due to a non-clinical safety finding.)
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00455429
First received: April 1, 2007
Last updated: February 11, 2014
Last verified: February 2014
Results First Received: February 28, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Atopic Dermatitis
Interventions: Drug: Placebo
Drug: JNJ-26113100 (50 mg) once daily
Drug: JNJ-26113100 (100 mg) once daily
Drug: JNJ-26113100 (100 mg) twice daily
Drug: JNJ-26113100 (250 mg) twice daily

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Placebo Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
JNJ-26113100 (50 mg) Once Daily JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
JNJ-26113100 (100 mg) Once Daily JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
JNJ-26113100 (100 mg) Twice Daily JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.

Participant Flow:   Overall Study
    Placebo     JNJ-26113100 (50 mg) Once Daily     JNJ-26113100 (100 mg) Once Daily     JNJ-26113100 (100 mg) Twice Daily  
STARTED     18     15     17     34  
Treated     18     15     17     32  
COMPLETED     16     10     16     20  
NOT COMPLETED     2     5     1     14  
Study Terminated by Sponsor                 0                 0                 0                 3  
Lost to Follow-up                 1                 0                 0                 3  
Withdrawal by Subject                 0                 1                 1                 0  
Lack of Efficacy                 0                 1                 0                 1  
Adverse Event                 0                 1                 0                 3  
Randomly assigned but not treated                 0                 0                 0                 2  
Personal Reason                 1                 0                 0                 0  
Non-compliance                 0                 0                 0                 1  
Unspecified                 0                 2                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
JNJ-26113100 (50 mg) Once Daily JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
JNJ-26113100 (100 mg) Once Daily JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
JNJ-26113100 (100 mg) Twice Daily JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
Total Total of all reporting groups

Baseline Measures
    Placebo     JNJ-26113100 (50 mg) Once Daily     JNJ-26113100 (100 mg) Once Daily     JNJ-26113100 (100 mg) Twice Daily     Total  
Number of Participants  
[units: participants]
  18     15     17     34     84  
Age  
[units: years]
Mean ± Standard Deviation
  33.2  ± 11.84     34.8  ± 14.67     34.6  ± 13.98     38.7  ± 14.50     36.0  ± 13.84  
Gender  
[units: participants]
         
Female     10     5     11     21     47  
Male     8     10     6     13     37  



  Outcome Measures
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1.  Primary:   Investigator's Global Assessment (IGA) Score at Week 6   [ Time Frame: Week 6 ]

2.  Primary:   Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6   [ Time Frame: Baseline and Week 6 ]

3.  Primary:   Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6   [ Time Frame: Baseline and Week 6 ]

4.  Primary:   Percentage of Participants Achieving Treatment Response as “Clear” or “Almost Clear “in IGA   [ Time Frame: Baseline up to Week 6 ]

5.  Primary:   Percentage of Participants Achieving 50% Reduction in EASI Score at Week 6   [ Time Frame: Baseline up to Week 6 ]

6.  Primary:   Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in EASI Score at Week 6   [ Time Frame: Baseline up to Week 6 ]

7.  Primary:   Percentage of Participants Achieving Greater Than (>) or Equal to (=) 75% Reduction in VAS Score for Pruritus at Week 6   [ Time Frame: Baseline up to Week 6 ]

8.  Primary:   Percentage of Participants Achieving Greater Than (>) or Equal to (=) 50% Reduction in VAS Score for Pruritus at Week 6   [ Time Frame: Baseline up to Week 6 ]

9.  Primary:   Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in VAS Score for Pruritus at Week 6   [ Time Frame: Baseline up to Week 6 ]

10.  Primary:   Percentage of Participants Who Had at Least 1 Flare   [ Time Frame: Baseline up to Week 6 ]

11.  Primary:   Number of Flare Occurrences Per Participant   [ Time Frame: Baseline up to Week 6 ]

12.  Primary:   Percentage of Participants Who Had at Least 1 Worsening AD Event   [ Time Frame: Baseline up to Week 6 ]

13.  Secondary:   Plasma Concentration of JNJ-26113100   [ Time Frame: Before dosing on Day 1, Week 3, Week 6; after dosing at 0.25 to 3 hours on Day 1, Week 3, Week 6; after dosing at 4 to 6 hours and 7 to 12 hours on Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Participants were not enrolled into JNJ-26113100(250 mg) twice daily dose because the study was stopped during 100mg twice daily dose due to preclinical finding of retinal atrophy in high dose group(150 mg/kg) of 6-month, albino rat toxicology study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: William Barchuk, M.D.
Organization: Janssen Research and Development, 3210 Merryfield Row San Diego, CA 92121
phone: 858-784-3111


No publications provided


Responsible Party: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00455429     History of Changes
Other Study ID Numbers: CR012946, C-2006-004
Study First Received: April 1, 2007
Results First Received: February 28, 2013
Last Updated: February 11, 2014
Health Authority: United States: Food and Drug Administration