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A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01945086
Recruitment Status : Completed
First Posted : September 18, 2013
Results First Posted : March 9, 2016
Last Update Posted : March 9, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Tracking Information
First Submitted Date  ICMJE September 13, 2013
First Posted Date  ICMJE September 18, 2013
Results First Submitted Date  ICMJE December 15, 2015
Results First Posted Date  ICMJE March 9, 2016
Last Update Posted Date March 9, 2016
Study Start Date  ICMJE September 2013
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2013)
Percent change from Baseline to Week 12 in the Eczema Area and Severity Index (EASI) score [ Time Frame: Baseline and Week 12 ]
The EASI is a measure of the severity and extent of atopic dermatitis (AD). Each of the 4 body regions (head and neck, trunk, upper limbs, and lower limbs) are assessed for severity of disease using a scale ranging from 0 (no disease) to 3 (severe disease). In addition, the area of skin affected by AD in each of the 4 body regions is determined using a scale ranging from 0 (no eruption) to 6 (90 to 100 percent extent of the body region affected). The higher the total EASI score, the greater the severity and extent of AD.
Change History Complete list of historical versions of study NCT01945086 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2016)
  • 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).
  • Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12 [ Time Frame: Baseline and Week 12 ]
    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.
  • Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 [ Time Frame: Baseline and Week 12 ]
    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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2013)
  • Percentage of participants with an Investigator's Global Assessment (IGA) score of "clear" or "almost clear" at Week 12 [ Time Frame: Baseline and Week 12 ]
    The IGA utilizes a 6-point scale ranging from 0 (clear) to 5 (very severe disease). "Almost clear" is given a score of 1.
  • Change from Baseline to Week 12 in Atopic Dermatitis Itch Scale (ADIS) [ Time Frame: Baseline and Week 12 ]
    The ADIS will be used to assess itching twice daily (morning and evening) and uses a scale ranging from 0 (no itching at all) to 10 (worst possible itching).
  • Change from Baseline to Week 12 in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline and Week 12 ]
    DLQI is a dermatology-specific quality of life instrument designed to assess the impact of the disease on a subject's quality of life. The DLQI uses 10 questions which are each scored on a scale of 0 to 3; the higher the score, the more quality of life is impaired.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Ustekinumab in Adult Japanese Subjects With Severe Atopic Dermatitis
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dermatitis, Atopic
Intervention  ICMJE
  • Drug: Ustekinumab
    Participants will receive subcutaneous (SC) injections of either ustekinumab 45 mg or ustekinumab 90 mg at Week 0 and Week 4.
  • Drug: Placebo
    Participants will receive SC injections of placebo at Week 0 and Week 4.
  • Other: Concomitant topical medications for atopic dermatitis
    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.
Study Arms  ICMJE
  • Experimental: Ustekinumab 45 mg
    Interventions:
    • Drug: Ustekinumab
    • Other: Concomitant topical medications for atopic dermatitis
  • Experimental: Ustekinumab 90 mg
    Interventions:
    • Drug: Ustekinumab
    • Other: Concomitant topical medications for atopic dermatitis
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: Placebo
    • Other: Concomitant topical medications for atopic dermatitis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 24, 2014)
79
Original Estimated Enrollment  ICMJE
 (submitted: September 13, 2013)
72
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01945086
Other Study ID Numbers  ICMJE CR102538
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Pharmaceutical K.K.
Study Sponsor  ICMJE Janssen Pharmaceutical K.K.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
PRS Account Janssen Pharmaceutical K.K.
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP