Study Stopped
The study was stopped due to a non-clinical safety finding.
An Efficacy and Safety Study of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis
A Double-Blind, Randomized, Placebo-Controlled, Sequential Cohort Exploratory Study of the Safety and Efficacy of JNJ-26113100 in the Treatment of Adult Atopic Dermatitis That is Moderate in Severity
2 other identifiers
interventional
84
1 country
19
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of four dose regimens (pattern of giving treatment) of JNJ-26113100 in the treatment of adult Atopic Dermatitis (\[AD\]; skin rash, inflammation) that is moderate in severity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2007
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2007
CompletedStudy Start
First participant enrolled
April 1, 2007
CompletedFirst Posted
Study publicly available on registry
April 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedResults Posted
Study results publicly available
July 1, 2013
CompletedMarch 12, 2014
February 1, 2014
1.9 years
April 1, 2007
February 28, 2013
February 11, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (12)
Investigator's Global Assessment (IGA) Score at Week 6
Participants were reported for IGA. IGA is an overall assessment of Atopic Dermatitis (AD). IGA utilizes a 6-point scale (ranging from 0 to 5): 0=clear (noinflammatory signs of AD), 1=almost clear (just perceptible erythema, and just perceptible papulation/infiltration), 2=mild disease (mild erythema, and mild papulation/infiltration), 3=moderate disease (moderate erythema, and moderate papulation/infiltration), 4=severe disease (severe erythema, and severe papulation/infiltration) and 5=very severe disease (severe erythema, and severe papulation/infiltration with oozing/crusting).
Week 6
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6
EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than \[\>\] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score.
Baseline and Week 6
Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6
VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm="No itch" on the left side of the line and the words 10 cm="Worst possible itch" on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between "No itch" and "Worst possible itch" which best describes their itching during the preceding 24 hours.
Baseline and Week 6
Percentage of Participants Achieving Treatment Response as "Clear" or "Almost Clear "in IGA
Percentage of participants achieving treatment response (decrease) in IGA were assessed. IGA is used to assess AD through a 6-point scale (Range=0-5) where, 0=clear (no inflammatory signs of AD), 1=almost clear (just perceptible erythema \& perceptible papulation/infiltration), 2=mild (mild erythema \& papulation/infiltration), 3=moderate (moderate erythema \& papulation/infiltration), 4=severe (severe erythema \& papulation/infiltration) \& 5=very severe (severe erythema \& papulation/infiltration with oozing/crusting). Success is reduction of IGA to 0 or 1. Failure is reduction of IGA to \>=2.
Baseline up to Week 6
Percentage of Participants Achieving 50% Reduction in EASI Score at Week 6
EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than \[\>\] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. Success is defined as an improvement of \>=50% from the baseline EASI score. An improvement of \<50% is considered a failure.
Baseline up to Week 6
Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in EASI Score at Week 6
EASI measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 (none) to 3 (severe) on 4 anatomic regions of the body: head, trunk, upper limbs, and lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no eruption) to 6 (greater than \[\>\] 90%-100% eruption). The total score is the sum of the four body-region scores, maximum=72, minimum=0, with higher scores reflecting greater disease severity. The total qualitative score is multiplied by the degree of involvement for each anatomic region and then multiplied by a constant and summed to yield the EASI score. Success is defined as an improvement of \>=25% from the baseline EASI score. An improvement of \<25% is considered a failure.
Baseline up to Week 6
Percentage of Participants Achieving Greater Than (>) or Equal to (=) 75% Reduction in VAS Score for Pruritus at Week 6
VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm="No itch" on the left side of the line and the words 10 cm="Worst Possible Itch" on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between "No itch" and "Worst possible itch" which best describes their itching during the preceding 24 hours. Success is defined as an improvement of \>=75% from the baseline VAS assessment of pruritus. An improvement of \<75% is a failure.
Baseline up to Week 6
Percentage of Participants Achieving Greater Than (>) or Equal to (=) 50% Reduction in VAS Score for Pruritus at Week 6
VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm="No itch" on the left side of the line and the words 10 cm="Worst possible itch" on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between "No itch" and "Worst possible itch" which best describes their itching during the preceding 24 hours. Success is defined as an improvement of \>=75% from the baseline VAS assessment of pruritus. An improvement of \<75% is a failure.
Baseline up to Week 6
Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in VAS Score for Pruritus at Week 6
VAS consists of 10 centimeter (cm) horizontal line and the words; 0 cm="No itch" on the left side of the line and the words 10 cm="Worst possible itch" on the right side of the line. Participants will be instructed to rate the severity of their pruritus within the previous 24 hours by drawing a vertical line across the 10 cm line at the point between "No itch" and "Worst possible itch" which best describes their itching during the preceding 24 hours. Success is defined as an improvement of \>=75% from the baseline VAS assessment of pruritus. An improvement of \<75% is a failure.
Baseline up to Week 6
Percentage of Participants Who Had at Least 1 Flare
Percentage of participants who had at Least 1 Flare while on treatment was assessed. A flare was considered to be present if the following criteria were met: 1) IGA was greater than or equal to 2, if IGA on most recent previous assessment was 0; 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.
Baseline up to Week 6
Number of Flare Occurrences Per Participant
A flare was considered to be present if the following criteria were met: 1) IGA was greater than or equal to 2, if IGA on most recent previous assessment was 0 or 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.
Baseline up to Week 6
Percentage of Participants Who Had at Least 1 Worsening AD Event
Percentage of Participants who had at least 1 Worsening AD Event That did not Meet Flare Criteria were assessed. Worsening of AD that did not meet flare criteria was documented. Flare was considered to be present if either of the following criteria were met: 1) IGA was=2, if IGA on most recent previous assessment was 0; 2) IGA had increased by at least 1 point, if IGA on most recent previous assessment was 1 or more.
Baseline up to Week 6
Secondary Outcomes (1)
Plasma Concentration of JNJ-26113100
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
Study Arms (5)
Placebo
PLACEBO COMPARATORJNJ-26113100 (50 mg) once daily
EXPERIMENTALJNJ-26113100 (100 mg) once daily
EXPERIMENTALJNJ-26113100 (100 mg) twice daily
EXPERIMENTALJNJ-26113100 (250 mg) twice daily
EXPERIMENTALInterventions
Matching placebo capsules to JNJ-26113100 (50 milligram \[mg\]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily or 250 mg orally twice daily for 6 weeks.
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
JNJ-26113100 (250 mg) capsules orally twice daily for 6 weeks.
Eligibility Criteria
You may qualify if:
- Female participants must have a negative serum pregnancy test at screening
- With the exception of well-controlled asthma, allergic rhinitis and food allergies, participants must be in good general health prior to study participation with no clinically significant abnormalities as assessed by the investigator and determined by medical history, physical examination, blood chemistry, complete blood count, coagulation tests, urinalysis and electrocardiogram (ECG)
- Male subjects must consent to utilize a medically acceptable method of contraception throughout the study including the washout period and for three months after the study is completed
You may not qualify if:
- Participants with screening alanine aminotransferase, alkaline phosphatase or direct bilirubin levels above the upper limit of normal
- Evidence of any skin condition that in the opinion of the investigator would interfere with assessment of atopic dermatitis
- Use of any investigational drugs within the previous 30 days prior to dosing or within a period of less than five times the drug's half-life, whichever is longer
- Use of any biologic within a period of 5 times its half-life
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Unknown Facility
Huntsville, Alabama, United States
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Stanford, California, United States
Unknown Facility
Vista, California, United States
Unknown Facility
Jacksonville, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Skokie, Illinois, United States
Unknown Facility
Albuquerque, New Mexico, United States
Unknown Facility
Rochester, New York, United States
Unknown Facility
Stony Brook, New York, United States
Unknown Facility
Sylvania, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
College Station, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Madison, Wisconsin, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
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.
Results Point of Contact
- Title
- William Barchuk, M.D.
- Organization
- Janssen Research and Development, 3210 Merryfield Row San Diego, CA 92121
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development L.L.C Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 1, 2007
First Posted
April 3, 2007
Study Start
April 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
March 12, 2014
Results First Posted
July 1, 2013
Record last verified: 2014-02