Atopic DermatitisPhase 2NCT00455429

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

A Phase 2 study testing JNJ-26113100 (50 mg) once daily, JNJ-26113100 (100 mg) once daily and JNJ-26113100 (100 mg) twice daily in people with Atopic Dermatitis, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 19 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Atopic Dermatitis
What is being tested?: JNJ-26113100 (50 mg) once daily, JNJ-26113100 (100 mg) once daily and JNJ-26113100 (100 mg) twice daily
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 84 participants
Where: 19 sitesUnited States
Study dates: Apr 2007to Mar 2009
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Inclusion Criteria:-Adult participants with Atopic Dermatitis (skin rash, inflammation) involving greater than or equal to 10 percent body surface area

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
Female participants of child bearing potential 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 Exclusion Criteria:-Evidence of clinically significant hepatic, reproductive, gastrointestinal, renal, hematologic, pulmonary, neurologic, respiratory (with the exception of well-controlled asthma), endocrine or cardiovascular abnormalities or psychiatric disorders
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

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Study site
Albuquerque, New Mexico
Study site
Chicago, Illinois
Study site
College Station, Texas
Study site
Huntsville, Alabama
Study site
Jacksonville, Florida
Study site
Los Angeles, California
Study site
Madison, Wisconsin
Study site
Philadelphia, Pennsylvania
Study site
Portland, Oregon
Study site
Rochester, New York
Study site
Sacramento, California
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
Seattle, Washington
Study site
Skokie, Illinois
Study site
Stanford, California
Study site
Stony Brook, New York
Study site
Sylvania, Ohio
Study site
Vista, California

Other trials in United States

About this study

Official title: 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

Read the detailed description

This study is a double-blind (neither the researchers nor the participants know what treatment the participant is receiving), randomized (study drug assigned by chance), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), sequential cohort exploratory study to evaluate the safety and effectiveness of JNJ-26113100 in the treatment of adult AD that is moderate in severity, including its effect on inflammatory biomarkers (biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease). Participants will be sequentially assigned to 50 milligram (mg) once daily, 100 mg once daily, 100 mg twice daily or 250 mg twice daily cohort and randomly assigned to receive JNJ-26113100 or matching placebo.

The total duration of the study will be approximately 8 weeks. Participants will be asked to follow-up at the end of Week 1, 2, 3, 4, 5 and 6. A study termination visit (Day 57) will be conducted at the end of Week 8. Skin biopsies from atopic dermatitis lesions will be collected during the study to assess changes in the inflammatory disease state. Participants developing flares of their disease may be treated with triamcinolone acetonide 0.1 percent ointment twice daily for up to 7 days. Efficacy will be assessed using Investigator's Global Assessment (IGA), Eczema Area and Severity Index (EASI) and Visual Analog Scale (VAS). Blood and urine samples will be collected for standard safety laboratory tests, to measure the level of drug and effect of the drug on inflammatory biomarkers. Participant's safety will be monitored throughout the study.

Conditions: Atopic Dermatitis
Being tested: Placebo, JNJ-26113100 (50 mg) once daily, JNJ-26113100 (100 mg) once daily, JNJ-26113100 (100 mg) twice daily, JNJ-26113100 (250 mg) twice daily
Keywords: Atopic Dermatitis, JNJ-26113100
Medical subject headings: Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlaceboDrug
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) once dailyDrug
JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
JNJ-26113100 (100 mg) once dailyDrug
JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
JNJ-26113100 (100 mg) twice dailyDrug
JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
JNJ-26113100 (250 mg) twice dailyDrug
JNJ-26113100 (250 mg) capsules orally twice daily for 6 weeks.

Study groups in NCT00455429
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
JNJ-26113100 (50 mg) once daily	Experimental	Not described Receives: Drug: JNJ-26113100 (50 mg) once daily
JNJ-26113100 (100 mg) once daily	Experimental	Not described Receives: Drug: JNJ-26113100 (100 mg) once daily
JNJ-26113100 (100 mg) twice daily	Experimental	Not described Receives: Drug: JNJ-26113100 (100 mg) twice daily
JNJ-26113100 (250 mg) twice daily	Experimental	Not described Receives: Drug: JNJ-26113100 (250 mg) twice daily

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline up to Week 6

Secondary outcomes (1)

Plasma Concentration of JNJ-26113100
Blood samples for pharmacokinetic (PK) analysis were collected before dosing and at 0.25 to 3 hours after dosing at randomization (Day 1) and Week 3 visit and at 0.25 to 3 hours, 4 to 6 hours, and 7 to 12 hours after dosing at Week 6.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2007Mar 2009

First posted3 Apr 2007 (estimated)
Study startApr 2007
Primary completionMar 2009
Study completionMar 2009

Why it stopped: The study was stopped due to a non-clinical safety finding.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atopic DermatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 84 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00455429
Sponsor's protocol ID: CR012946
Other IDs: C-2006-004
Status last verified: Feb 2014
First submitted: 1 Apr 2007
Last updated: 12 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT00455429
Acronym / sponsor ID: CR012946
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis, JNJ-26113100
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: The study was stopped due to a non-clinical safety finding.
Enrolment: 84 participants (actual)
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
Study start: Apr 2007
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 3 Apr 2007 (estimated)
Results: Posted 1 Jul 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
JNJ-26113100 (50 mg) once daily	Experimental	Drug: JNJ-26113100 (50 mg) once daily
JNJ-26113100 (100 mg) once daily	Experimental	Drug: JNJ-26113100 (100 mg) once daily
JNJ-26113100 (100 mg) twice daily	Experimental	Drug: JNJ-26113100 (100 mg) twice daily
JNJ-26113100 (250 mg) twice daily	Experimental	Drug: JNJ-26113100 (250 mg) twice daily

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PlaceboMatching 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.	Drug	Placebo
JNJ-26113100 (50 mg) once dailyJNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.	Drug	JNJ-26113100 (50 mg) once daily
JNJ-26113100 (100 mg) once dailyJNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.	Drug	JNJ-26113100 (100 mg) once daily
JNJ-26113100 (100 mg) twice dailyJNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.	Drug	JNJ-26113100 (100 mg) twice daily
JNJ-26113100 (250 mg) twice dailyJNJ-26113100 (250 mg) capsules orally twice daily for 6 weeks.	Drug	JNJ-26113100 (250 mg) twice daily

Primary outcome

Investigator's Global Assessment (IGA) Score at Week 6
Time frame: 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).
Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6
Time frame: Baseline and 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.
Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6
Time frame: Baseline and 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.
Percentage of Participants Achieving Treatment Response as "Clear" or "Almost Clear "in IGA
Time frame: Baseline up to Week 6
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.
Percentage of Participants Achieving 50% Reduction in EASI Score at Week 6
Time frame: Baseline up to 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.
Percentage of Participants Achieving Greater Than (>) or Equal to (=) 25% Reduction in EASI Score at Week 6
Time frame: Baseline up to 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.
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
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.
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
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.
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
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.
Percentage of Participants Who Had at Least 1 Flare
Time frame: Baseline up to Week 6
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.
Number of Flare Occurrences Per Participant
Time frame: Baseline up to Week 6
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.
Percentage of Participants Who Had at Least 1 Worsening AD Event
Time frame: Baseline up to Week 6
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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 1 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	18	16
JNJ-26113100 (50 mg) Once Daily	15	10
JNJ-26113100 (100 mg) Once Daily	17	16
JNJ-26113100 (100 mg) Twice Daily	34	20

Primary outcome: Investigator's Global Assessment (IGA) Score at Week 6

Time frame: Week 6. Number. Unit: participants

Measure	Placebo n = 18	JNJ-26113100 (50 mg) Once Daily n = 15	JNJ-26113100 (100 mg) Once Daily n = 17	JNJ-26113100 (100 mg) Twice Daily n = 32
Clear	1	1	1	2
Almost Clear	3	4	2	4
Mild Disease	5	3	4	5
Moderate Disease	7	6	9	19
Severe Disease	2	1	1	2

Placebo vs JNJ-26113100 (50 mg) Once Daily: p = 0.600, Cochran-Mantel-Haenszel
Placebo vs JNJ-26113100 (100 mg) Once Daily: p = 0.822, Cochran-Mantel-Haenszel
Placebo vs JNJ-26113100 (100 mg) Twice Daily: p = 0.656, Cochran-Mantel-Haenszel

Population analysed: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. Last Observation Carried Forward (LOCF) method was used.

Primary outcome: Change From Baseline in Eczema Area and Severity Index (EASI) Score at Week 6

Time frame: Baseline and Week 6. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 18	JNJ-26113100 (50 mg) Once Daily n = 15	JNJ-26113100 (100 mg) Once Daily n = 17	JNJ-26113100 (100 mg) Twice Daily n = 32
Baseline	13.7 (10.93)	12.6 (6.63)	14.3 (9.32)	17.2 (12.23)
Change at Week 6	-2.3 (5.97)	-5.5 (5.78)	-3.7 (7.18)	-4.2 (9.67)

Placebo vs JNJ-26113100 (50 mg) Once Daily: LS Mean difference: -3.4 (95% CI -9.70 to 2.90), p = 0.427, Dunnett-Hsu
Placebo vs JNJ-26113100 (100 mg) Once Daily: LS Mean Difference: -1.3 (95% CI -7.37 to 4.82), p = 0.922, Dunnett-Hsu
Placebo vs JNJ-26113100 (100 mg) Twice Daily: LS Mean Difference: -1.1 (95% CI -6.49 to 4.21), p = 0.919, Dunnett-Hsu

Population analysed: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.

Primary outcome: Change From Baseline in Visual Analog Scale (VAS) Score for Pruritus at Week 6

Time frame: Baseline and Week 6. Mean (Standard Deviation). Unit: millimeter (mm)

Measure	Placebo n = 18	JNJ-26113100 (50 mg) Once Daily n = 15	JNJ-26113100 (100 mg) Once Daily n = 17	JNJ-26113100 (100 mg) Twice Daily n = 32
Baseline	49.4 (27.94)	47.9 (27.78)	65.3 (18.37)	63.4 (23.02)
Change at Week 6	-24.8 (32.44)	-19.9 (31.16)	-22.8 (26.66)	-20.6 (29.18)

Placebo vs JNJ-26113100 (50 mg) Once Daily: LS Mean difference: 3.7 (95% CI -15.83 to 23.18), p = 0.941, Dunnett-Hsu
Placebo vs JNJ-26113100 (100 mg) Once Daily: LS Mean Difference: 14.2 (95% CI -5.12 to 33.52), p = 0.196, Dunnett-Hsu
Placebo vs JNJ-26113100 (100 mg) Twice Daily: LS Mean Difference: 14.9 (95% CI -2.00 to 31.86), p = 0.096, Dunnett-Hsu

Population analysed: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.

Primary outcome: Percentage of Participants Achieving Treatment Response as "Clear" or "Almost Clear "in IGA

Time frame: Baseline up to Week 6. Number. Unit: percentage of participants

Measure	Placebo n = 18	JNJ-26113100 (50 mg) Once Daily n = 15	JNJ-26113100 (100 mg) Once Daily n = 17	JNJ-26113100 (100 mg) Twice Daily n = 32
Success	27.8 (27.94)	40.0 (27.78)	17.6 (18.37)	18.8 (23.02)
Failure	72.2 (32.44)	60.0 (31.16)	82.4 (26.66)	81.3 (29.18)

Placebo vs JNJ-26113100 (50 mg) Once Daily: p = 0.460, Regression, Logistic
Placebo vs JNJ-26113100 (100 mg) Once Daily: p = 0.479, Regression, Logistic
Placebo vs JNJ-26113100 (100 mg) Twice Daily: p = 0.462, Regression, Logistic

Population analysed: Efficacy evaluable analysis set included participants who had at least 1 efficacy assessment during the dosing period. LOCF method was used.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From signing of informed consent until the study termination visit (Day 57). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 18 (0%)	12 of 18 (66.7%)	Not reported
JNJ-26113100 (50 mg) Once Daily	0 of 15 (0%)	10 of 15 (66.7%)	Not reported
JNJ-26113100 (100 mg) Once Daily	0 of 17 (0%)	14 of 17 (82.4%)	Not reported
JNJ-26113100 (100 mg) Twice Daily	0 of 32 (0%)	31 of 32 (96.9%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Johnson & Johnson Pharmaceutical Research & Development L.L.C Clinical Trial study director

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator's Global Assessment (IGA) Score at Week 6 (time frame: Week 6). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00455429.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2014.