Phase 2
Completed N=79
A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis
Dermatitis, Atopic
Source: ClinicalTrials.gov NCT01945086 ↗
Enrolled (actual)
79
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12 — -37.54; -38.62; -39.39 percent change
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Eczema Area Severity Index (EASI) Total Score From Baseline at Week 12 |
-37.54; -38.62; -39.39 | — |
| SECONDARY Number of Participants With an Investigator's Global Assessment (IGA) Score of "Clear" or "Almost Clear" at Week 12 |
0; 0; 0 | — |
| SECONDARY Change From Baseline in Atopic Dermatitis Itch Scale (ADIS) at Week 12 |
8.97; 10.03; 8.71; -1.58; -1.68; -2.59 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12 |
6.3; 6.4; 6.6; -0.6; -1.7; -1.7 | — |
| SECONDARY Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) and >=75% Decrease in EASI Total Score From Baseline |
3; 2; 7; 1; 0; 0 | — |
| SECONDARY Number of Participants With an IGA Score of "Clear" or "Almost Clear" |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Greater Than or Equal to 2 Points Decrease in IGA From Baseline |
2; 1; 4; 5; 2; 3 | — |
| SECONDARY Number of Participants in IGA |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percent Change From Baseline in EASI Total Score |
-24.29; -13.85; -25.72; -31.69; -21.13; -29.19 | — |
| SECONDARY Percent Change From Baseline in EASI Sign of Disease Components |
-19.51; -12.03; -19.13; -23.24; -17.17; -21.51 | — |
| SECONDARY Percent Change From Baseline of Body Region Scores in EASI |
-20.28; -6.97; -29.50; -26.22; -17.46; -34.15 | — |
| SECONDARY Number of Participants With Mild or Absent Key Sign of Atopic Dermatitis (AD) |
0; 0; 0; 1; 0; 1 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01945086). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.