Tokyo, April 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061150) titled 'Atopic Dermatitis - Treatment Response EVALuation and UsEr Satisfaction with Tralokinumab in Standard Clinical Practice in Japan' on April 8.
Study Type:
Observational
Primary Sponsor:
Institute - LEO Pharma K.K.
Condition:
Condition - atopic dermatitis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - This observational study aims to assess the 52-week real-world effectiveness, safety, and patient-reported outcomes of tralokinumab. Furthermore, the data will be integrated with international studies to characterize the global clinical profile of the treatment.
Basic objectives2 - Efficacy
Eligibility:
Age-lower limit - 15
years-old
= 15 years of age
4. Written informed consent obtained prior to enrolment, as follows:
-Patients aged >= years: obtained directly from the patient.
-Patients aged 15 to 17 years: obtained from the legal guardian, and written assent is additionally obtained from the adolescent who is capable of forming an opinion and understanding the information provided.
Key exclusion criteria - 1.Enrolment in an interventional study
2.Prior enrolment in this study
3.Prior treatment with tralokinumab (including prior use in a clinical trial).
4.Lack of capability by patient/or caregiver to give informed consent
Target Size - 300
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 27 Day
Date of IRB - 2026 Year 03 Month 27 Day
Anticipated trial start date - 2026 Year 04 Month 10 Day
Last follow-up date - 2030 Year 05 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069294
Disclaimer: Curated by HT Syndication.
