Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance

September 19, 2025 updated by: Kyowa Kirin Co., Ltd.
The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Ewha Womans University Mokdong Hospital
        • Contact:
          • Ewha Womans University Mokdong Hospital hemato oncology
          • Phone Number: +82-2-2650-5063
          • Email: yeungchul@ehwa.ac.kr
        • Principal Investigator:
          • Yeungchul Moon
      • Seoul, South Korea
        • Recruiting
        • Samsung Medical Center
        • Principal Investigator:
          • SeokJin Kim
        • Contact:
          • Samsung Medical Center hemato oncology
          • Phone Number: +82 2-3410-6856
          • Email: kstwoh@skku.edu
      • Seoul, South Korea
        • Recruiting
        • Seoul National University Hospital
        • Principal Investigator:
          • Youngil Koh
        • Contact:
          • Seoul National University Hospital hemato-oncology
          • Phone Number: +82 2-2072-4990
          • Email: go01@snu.ac.kr
      • Seoul, South Korea
        • Terminated
        • Chung-Ang University Hospital
    • Busan Metropolitan City
      • Busan, Busan Metropolitan City, South Korea, 49267
        • Recruiting
        • Kosin university gospel hospital
        • Principal Investigator:
          • Ho Sup Lee
        • Contact:
          • Kosin University Gospel Hospital hemato oncology
          • Phone Number: +82-51-990-6770
          • Email: hs52silver@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

A person who has Mycosis fungoides and sezary syndrome.

Description

Inclusion Criteria:

  1. Adults 19 years of age or older
  2. Individuals who are confirmed to have received administration of the study drug for the purpose of "the treatment for adult patients with fungoidal granuloma or Sezary syndrome who have received one or more systemic therapies," or who are considered to require administration of the study drug in the investigator's opinion
  3. Individuals who (or whose legally acceptable representatives) signed the Consent to Use of Personal Information of their own free will for participation in this use-result surveillance

Exclusion Criteria

  1. Patients with hypersensitivity to any ingredients of this drug
  2. Patients who intend to use this drug for non-approved indications
  3. Patients who participated in a pre-market clinical trial of the study drug and received administration of the study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety (Special situation, adverse event, symptom, or disease occurring during treatment with Poteligeo)
Time Frame: From first administration of Poteligeo through 90 days after the last dose
Number of participants who experience any adverse event or special situation during Poteligeo treatment and up to 90 days after the last dose, as recorded in CRFs based on medical examinations or spontaneous reports.
From first administration of Poteligeo through 90 days after the last dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline to after 8th administration in Global Response Score (GRS)
Time Frame: Baseline (Day 1, prior to first dose) and Week 24 (after completion of 8th administration)
Change in Global Response Score (GRS) from baseline (before first dose) to after the 8th administration, assessing skin, nodes, blood, and viscera. CR/PR = Effective; SD/PD/Relapse = Ineffective.
Baseline (Day 1, prior to first dose) and Week 24 (after completion of 8th administration)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin Co., Ltd.

Investigators

  • Study Director: HaeMi Park, Kyowa Kirin Korea Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2025

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

July 22, 2025

First Submitted That Met QC Criteria

August 17, 2025

First Posted (Actual)

August 20, 2025

Study Record Updates

Last Update Posted (Actual)

September 22, 2025

Last Update Submitted That Met QC Criteria

September 19, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Poteligeo PMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make IPD available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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