Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT07132567
Brief Summary:
The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.
Detailed Description:
This post-marketing surveillance (PMS) is designed as an all-case investigation in accordance with the Korean Ministry of Food and Drug Safety (MFDS) re-examination requirements. It targets adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy and are treated with mogamulizumab (POTELIGEO® Injection 20 mg) under the approved indication in Korea.
Primary Objective: To assess the safety of mogamulizumab for patients treated under the approved indication in Korea.
Secondary Objective: To assess the effectiveness of mogamulizumab for patients treated under the approved indication in Korea.
Exploratory Objective: To perform additional subgroup and exploratory analyses of effectiveness, including evaluation in special populations such as elderly patients, patients with renal or hepatic impairment, and those with a history of hematopoietic stem cell transplantation, treated under the approved indication in Korea
Study:
NCT07132567
Study Brief:
Protocol Section:
NCT07132567