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

NCT01945086 | Completed Phase 2 Results

• 1 other identifier: CR102538
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 13

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.

Conditions

Dermatitis, Atopic

Keywords

Dermatitis, Atopic; Eczema; Ustekinumab; CNTO1275; STELARA

Outcome Measures

Primary Outcomes (1)

• Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at 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

Secondary Outcomes (11)

• Number of Participants With an Investigator's Global Assessment (IGA) Score of "Clear" or "Almost Clear" at Week 12

  Week 12

• Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12

  Baseline and Week 12

• Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12

  Baseline and Week 12

• Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline

  Week 2, 4, 8, 12, 16, 20 and 24

• Number of Participants With an IGA Score of "Clear" or "Almost Clear"

  Baseline, Week 2, 4, 8, 12, 16, 20 and 24

Study Arms (3)

Ustekinumab 45 mg

EXPERIMENTAL

Drug: Ustekinumab; Other: Concomitant topical medications for atopic dermatitis

Ustekinumab 90 mg

EXPERIMENTAL

Drug: Ustekinumab; Other: Concomitant topical medications for atopic dermatitis

Placebo

PLACEBO COMPARATOR

Drug: Placebo; Other: Concomitant topical medications for atopic dermatitis

Interventions

Ustekinumab DRUG

Participants will receive subcutaneous (SC) injections of either ustekinumab 45 mg or ustekinumab 90 mg at Week 0 and Week 4.

Ustekinumab 45 mg; Ustekinumab 90 mg

Placebo DRUG

Participants will receive SC injections of placebo at Week 0 and Week 4.

Placebo

Concomitant topical medications for atopic dermatitis OTHER

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; Ustekinumab 45 mg; Ustekinumab 90 mg

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead

Study Sites (13)

Unknown Facility

Chitose, Japan

Location

Unknown Facility

Habikino, Japan

Location

Unknown Facility

Hamamatsu, Japan

Location

Unknown Facility

Hiroshima, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Kurume, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Maebashi, Japan

Location

Unknown Facility

Nagasaki, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Suita, Japan

Location

Unknown Facility

Tokyo, Japan

Location

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Director Clinical Research
• Organization: Janssen Research & Development, LLC.

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2013
• First Posted: September 18, 2013
• Study Start: September 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 9, 2016
• Results First Posted: March 9, 2016

Record last verified: 2016-02

Locations

JP (13)