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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT01945086
First received: September 13, 2013
Last updated: July 24, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Dermatitis, Atopic
Drug: Ustekinumab
Drug: Placebo
Other: Concomitant topical medications for atopic dermatitis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Ustekinumab in Adult Japanese Subjects With Severe Atopic Dermatitis

Resource links provided by NLM:


Further study details as provided by Janssen Pharmaceutical K.K.:

Primary Outcome Measures:
  • Percent change from Baseline to Week 12 in the Eczema Area and Severity Index (EASI) score [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 79
Study Start Date: September 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ustekinumab 45 mg Drug: Ustekinumab
Participants will receive subcutaneous (SC) injections of either ustekinumab 45 mg or ustekinumab 90 mg 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.
Experimental: Ustekinumab 90 mg Drug: Ustekinumab
Participants will receive subcutaneous (SC) injections of either ustekinumab 45 mg or ustekinumab 90 mg 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.
Placebo Comparator: Placebo 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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01945086

Locations
Japan
Chitose, Japan
Habikino, Japan
Hamamatsu, Japan
Hiroshima, Japan
Kumamoto, Japan
Kurume, Japan
Kyoto, Japan
Maebashi, Japan
Nagasaki, Japan
Osaka, Japan
Sapporo, Japan
Suita, Japan
Tokyo, Japan
Sponsors and Collaborators
Janssen Pharmaceutical K.K.
Investigators
Study Director: Janssen Pharmaceutical K.K., Japan Clinical Trial Janssen Pharmaceutical K.K.
  More Information

No publications provided

Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01945086     History of Changes
Other Study ID Numbers: CR102538
Study First Received: September 13, 2013
Last Updated: July 24, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Janssen Pharmaceutical K.K.:
Dermatitis, Atopic
Eczema
Ustekinumab
CNTO1275
STELARA

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 28, 2014