Actively Recruiting
Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance
Led by Kyowa Kirin Co., Ltd. · Updated on 2025-09-22
15
Participants Needed
6
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the safety and effectiveness of Poteligeo Injection 20 mg (mogamulizumab) in adult patients with mycosis fungoides or S e9zary syndrome. It is conducted as a post-marketing surveillance study following regulatory requirements in Korea, focusing on patients who have previously received systemic therapy and are treated with mogamulizumab under approved indications. The study also explores effects in special groups such as elderly patients and those with kidney or liver impairment or prior stem cell transplants. Participants receive mogamulizumab according to routine clinical care without experimental randomization or placebo groups, as this is an observational study. The study monitors treatment from the first administration and continues through the treatment period, including assessments up to 90 days after the last dose. Additional analyses consider effectiveness after the eighth administration, particularly changes in the Global Response Score. Throughout the study, patients undergo safety monitoring for any adverse events or symptoms during treatment. Effectiveness is evaluated by comparing baseline and post-treatment response scores at specified time points. The study involves consented adult patients treated in real-world clinical settings and follows them through their treatment course to gather comprehensive safety and effectiveness data, with a planned end date in November 2028.
CONDITIONS
Brief Title
Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 19 years of age or older
- Confirmed to have received Poteligeo for treatment of mycosis fungoides or S�e9zary syndrome with one or more prior systemic therapies, or considered to require it by the investigator
- Provided signed consent for use of personal information for participation
You will not qualify if you...
- Known hypersensitivity to any ingredients of Poteligeo
- Intending to use Poteligeo for non-approved indications
- Participation in a pre-market clinical trial of Poteligeo with prior administration of the drug
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Until completion of 8 doses, approximately 24 weeks
Participants receive Poteligeo 20 mg as prescribed under routine care and are monitored for safety and effectiveness.
Baseline visit and follow-up visits through Week 24
Duration - 90 days after last dose
Participants are monitored for safety for 90 days after their last dose of Poteligeo.
Approximately 1 follow-up visit during safety monitoring
Trial Site Locations
Total: 6 locations
1
Kosin University Gospel Hospital
Busan, Busan Metropolitan City, South Korea, 49267
Actively Recruiting
2
Chung-Ang University Hospital
Seoul, South Korea
Terminated
3
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Actively Recruiting
4
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
5
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
6
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
H
HaeMi Park
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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