Tralokinumab in combination with topical corticosteroids in Japanese subjects with moderate to severe atopic dermatitis

JRCT ID: jRCT2031200162

Registered date:16/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Atopic Dermatitis
• Date of first enrollment: 27/10/2020
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Week 0 to Week 16: Tralokinumab or placebo will be given as subcutaneous injections. Participants will receive tralokinumab or placebo loading dose on Day 0 followed by multiple tralokinumab or placebo injections. The last administration will occur at Week 14. Topical corticosteroids (TCS) will be administered as needed.

Outcome(s)

Primary Outcome

- Investigator's Global Assessment (IGA) score of 0 (clear) or 1 (almost clear) (IGA 0 or 1) at Week 16.
- At least 75 % reduction in Eczema Area and Severity Index (EASI75) at Week 16.

Secondary Outcome

- Change in Scoring Atopic Dermatitis (SCORAD) total score from baseline to Week 16.
- Change in Dermatology Life Quality Index (DLQI) score from baseline to Week 16.
- Reduction of Worst Daily Pruritus numeric rating scale (NRS) score (weekly average) more than or equal to 4 from baseline to Week 16.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

- 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.

Exclude criteria

- 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

Related Information

• Primary Sponsor: Kato Norito