Tralokinumab in combination with topical corticosteroids in Japanese subjects with moderate to severe atopic dermatitis
- Conditions
- Atopic DermatitisD003876
- Registration Number
- JPRN-jRCT2031200162
- Lead Sponsor
- Kato Norito
- Brief Summary
Primary objective: To evaluate the efficacy of tralokinumab in combination with topical corticosteroids (TCS) compared with placebo in combination with TCS in treating moderate-to-severe atopic dermatitis (AD). Secondary objectives: To evaluate the efficacy of tralokinumab in combination with TCS on severity and extent of AD, itch, health-related quality of life, and health care resource utilisation compared with placebo in combination with TCS. To assess the safety of tralokinumab in combination wit
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 106
Japanese subject aged 18 years and above.
- Diagnosis of AD as defined by the Hanifin and Rajka (1980) criteria for AD.
- History of AD for 1 year or more.
- A recent history (within 1 year before screening) of inadequate response to treatment with topical medication.
- AD involvement of 10% or more body surface area at screening and at baseline according to component A of SCORAD.
- Applied a stable dose of emollient twice daily (or more, as needed) for at least 14 days before randomisation.
- Subjects for whom TCS are medically inadvisable e.g. due to important side effects or safety risks in the opinion of the investigator.
- Active dermatologic conditions that may confound the diagnosis of AD or would interfere with assessment of treatment.
- Use of tanning beds or phototherapy within 6 weeks prior to randomisation.
- Treatment with systemic immunosuppressive/immunomodulating drugs and/or systemic corticosteroids within 4 weeks prior to randomisation.
- Treatment with TCS, topical calcineurin inhibitors, topical phosphodiesterase-4 inhibitors, or topical Janus kinase inhibitors within 2 weeks prior to randomisation.
- Receipt of any marketed biological therapy (i.e. immunoglobulin, antiimmunoglobulin E) including dupilumab or investigational biologic agents 3 to 6 months prior to randomisation.
- Active skin infections within 1 week prior to randomisation
- Clinically significant infection within 4 weeks prior to randomisation
A helminth parasitic infection within 6 months prior to the date informed consent is obtained
- Tuberculosis requiring treatment within the 12 months prior to screening
- Known primary immunodeficiency disorder
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method