- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01945086
A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis
February 11, 2016 updated by: Janssen Pharmaceutical K.K.
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Ustekinumab in Adult Japanese Subjects With Severe Atopic Dermatitis
The purpose of this study is to assess the safety and effectiveness of 2 doses of ustekinumab compared with placebo (inactive medication) in adult Japanese participants with severe atopic dermatitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (one of the study medications is inactive), multicenter, parallel group study (each participant group receives different treatments simultaneously).
Participants will be randomly assigned in a 1:1:1 ratio to receive either ustekinumab 45 mg, ustekinumab 90 mg, or placebo.
The study will consist of a screening period, a 12-week double-blind treatment period, and a 12-week follow-up period.
During the double-blind treatment period, participants will receive one subcutaneous injection of study medication at Week 0 and Week 4. Participants will return to the study center for 7 evaluation visits on Weeks 2, 4, 8, 12, 16, 20, and 24.
Clinical response will be evaluated by Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), photography, and Dermatology Life Quality Index (DLQI).
Participants will record their itch condition twice daily using the participant daily diary from 2 weeks prior to randomization until Week 12. Blood samples will be drawn at time periods during the screening, double-blind treatment, and follow-up periods.
Participant safety will be monitored throughout the study.
Participants are permitted to use concomitant topical medications, as defined in the protocol and without any increase in dose, from 4 weeks prior to randomization through to the end of the treatment period.
After Week 12, additional treatment can be started or the dose of concomitant medications can be increased, if no improvement in clinical response is observed; in these cases EASI, IGA, and photography evaluations will be stopped.
The study duration for each participant is expected to be approximately 30 weeks.
Ustekinumab (also known as STELARA) is an antibody medication that inhibits the inflammatory proteins IL-12 and IL-23 and is approved as a treatment for moderate to severe plaque-type psoriasis; this study will examine whether ustekinumab can provide benefit in atopic dermatitis and assess for any risks or side effects.
Study Type
Interventional
Enrollment (Actual)
79
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Chitose, Japan
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Habikino, Japan
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Hamamatsu, Japan
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Hiroshima, Japan
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Kumamoto, Japan
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Kurume, Japan
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Kyoto, Japan
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Maebashi, Japan
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Nagasaki, Japan
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Osaka, Japan
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Sapporo, Japan
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Suita, Japan
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Tokyo, Japan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Must be Japanese
- Must have a diagnosis of atopic dermatitis, with childhood onset (under age of 13), in accordance with the definition and diagnostic criteria of the Japanese Dermatological Association and must have pruritus and eczematous changes; the condition must be chronic or chronically relapsing in nature
- Inadequate response to, or not willing to use strong treatment with a topical corticosteroid and/or a topical calcineurin inhibitor and/or phototherapy
- Must meet all the following criteria regarding severity of atopic dermatitis: Rajka-Langeland score of 8 to 9; severe or very severe disease as defined in standard treatment guidelines; an Eczema Area and Severity Index (EASI) score of >= 12; and an Investigator's Global Assessment (IGA) score of severe disease or very severe disease
- Must conform to the following tuberculosis (TB) screening criteria: no history of latent or active TB prior to screening; no signs or symptoms suggestive of active TB; no recent close contact with a person with active TB; and a negative Interferon Gamma Release Assay (IGRA) result within 2 months prior to the first administration of study drug
Exclusion Criteria:
- History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- Has an indeterminate initial and repeat IGRA result or a newly positive IGRA result and is unwilling or unable to undergo TB prophylaxis treatment
- Has received any of the following medications or therapies within 4 weeks prior to randomization: systemic non-steroid immunosuppressive or immunomodulatory drugs; systemic corticosteroids; high daily dose of inhaled corticosteroids; topical corticosteroids of strongest potency for atopic dermatitis; topical antihistamines (including topical doxepin); topical anesthetics; topical nonsteroidal anti-inflammatory drugs; topical counter-irritants (eg, capsaicin, menthol, wintergreen oil); antidepressants or antipsychotics; soporifics; phototherapy including ultraviolet A , ultraviolet B, and psoralen with ultraviolet A (PUVA); hyposensitization (desensitization) therapy
- Has changed the dose and dosing regimen within 4 weeks prior to randomization of any of the following drugs: topical corticosteroid (excluding the strongest potency) for atopic dermatitis; topical calcineurin inhibitor; emollients; anti-leukotriene therapies (including therapies for other allergic indications); systemic histamine H1 blocker (including sleep medications with antihistamine properties); sodium cromoglicate; suplatast tosilate; tranilast; thromboxane A2 inhibitors; and topical or oral herbal preparations for the treatment of atopic dermatitis
- Has received any of the following biologic agents within the following time periods: any marketed immunomodulatory biologic within a period of 3 months or 5 half-lives, whichever is longer, prior to randomization; a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275), briakinumab (ABT-874), guselkumab (CNTO 1959) or MK-3222 at any point in time; or an experimental biologic therapy within the previous 6 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
Concomitant topical medications (as defined in the protocol) can be used from 4 weeks prior to randomization and throughout the study.
However, the dosage cannot be increased and new medications cannot be added until after Week 12.
Participants will receive SC injections of placebo at Week 0 and Week 4.
|
Experimental: Ustekinumab 45 mg
|
Participants will receive subcutaneous (SC) injections of either ustekinumab 45 mg or ustekinumab 90 mg at Week 0 and Week 4.
Concomitant topical medications (as defined in the protocol) can be used from 4 weeks prior to randomization and throughout the study.
However, the dosage cannot be increased and new medications cannot be added until after Week 12.
|
Experimental: Ustekinumab 90 mg
|
Participants will receive subcutaneous (SC) injections of either ustekinumab 45 mg or ustekinumab 90 mg at Week 0 and Week 4.
Concomitant topical medications (as defined in the protocol) can be used from 4 weeks prior to randomization and throughout the study.
However, the dosage cannot be increased and new medications cannot be added until after Week 12.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12
Time Frame: Baseline and Week 12
|
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and 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 percent [%]-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 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With an Investigator's Global Assessment (IGA) Score of "Clear" or "Almost Clear" at Week 12
Time Frame: Week 12
|
The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).
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Week 12
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Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12
Time Frame: Baseline and Week 12
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The atopic dermatitis itch scale (ADIS) will be used to assess pruritus (itching) among participants with AD.
It will be evaluated by participant diary kept twice daily,in the morning(morning daily score[MDS]) and evening (Evening Daily Score[EDS]).
The start-of-day item set consists of 4 items:itching at time of completing morning diary(Q1),presence of itching during night before(Q2), itching at its worst at night (Q3), and impact of itching on sleep at night(Q4).
Appropriate items are summed to yield total score ranging from 0=minimum to 23=maximum, with higher scores reflecting greater itching.
The end-of day item set also consists of 4 items: itching at time of completing the evening diary(Q1),the presence of itching during the day(Q2),itching at its worst during the day(Q3),and amount of time the participant experienced eczema-related itching(Q4).
Appropriate items are summed to yield total score ranging from 0=minimum to 24=maximum,with higher scores reflecting greater itching.
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Baseline and Week 12
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Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12
Time Frame: Baseline and Week 12
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The DLQI is a dermatology-specific quality of life (QOL) instrument designed to assess impact of disease on a participants QOL.
It is a 10-item questionnaire that, in addition to evaluating overall, QOL can be used to assess 6 different aspects: symptoms and feelings, daily activities, leisure, work or school performance, personal relationships and treatment.
Questions scored on a 4-point Likert scale: 0 (not relevant), 1 (a little), 2 (a lot), and 3 (very much).
Scores of individual items (0-3) were added to yield a total score (0-30); higher score = greater impairment of participants QOL.
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Baseline and Week 12
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Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline
Time Frame: Week 2, 4, 8, 12, 16, 20 and 24
|
The EASI score was used to measure the severity and extent of AD and 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.
|
Week 2, 4, 8, 12, 16, 20 and 24
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Number of Participants With an IGA Score of "Clear" or "Almost Clear"
Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20 and 24
|
The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).
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Baseline, Week 2, 4, 8, 12, 16, 20 and 24
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Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline
Time Frame: Week 2, 4, 8, 12, 16, 20 and 24
|
The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).
|
Week 2, 4, 8, 12, 16, 20 and 24
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Number of Participants in IGA
Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20 and 24
|
The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease) where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, 4 = severe and 5 (very severe disease).
|
Baseline, Week 2, 4, 8, 12, 16, 20 and 24
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Percent Change From Baseline in EASI Total Score
Time Frame: Week 2, 4, 8, 12, 16, 20 and 24
|
The EASI score was used to measure the severity and extent of AD and 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.
|
Week 2, 4, 8, 12, 16, 20 and 24
|
Percent Change From Baseline in EASI Sign of Disease Components
Time Frame: Week 2, 4, 8, 12, 16, 20 and 24
|
The EASI score was used to measure the severity and extent of AD and 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.
|
Week 2, 4, 8, 12, 16, 20 and 24
|
Percent Change From Baseline of Body Region Scores in EASI
Time Frame: Week 2, 4, 8, 12, 16, 20 and 24
|
The EASI score was used to measure the severity and extent of AD and 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.
|
Week 2, 4, 8, 12, 16, 20 and 24
|
Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD)
Time Frame: Baseline, Week 2, 4, 8, 12, 16, 20 and 24
|
The EASI score was used to measure the severity and extent of AD and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on a scale of 0 to 3 where 0=none, 1=mild, 2=moderate, 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, Week 2, 4, 8, 12, 16, 20 and 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
September 13, 2013
First Submitted That Met QC Criteria
September 13, 2013
First Posted (Estimate)
September 18, 2013
Study Record Updates
Last Update Posted (Estimate)
March 9, 2016
Last Update Submitted That Met QC Criteria
February 11, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR102538
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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