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

NCT07132567 | Recruiting

• 1 other identifier: Poteligeo PMS
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 6

Brief Summary

The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.

Conditions

Mycosis Fungoides; Sezary Syndrome

Keywords

Poteligeo; mycosis fungoides; Sezary syndrome

Outcome Measures

Primary Outcomes (1)

• Safety (Special situation, adverse event, symptom, or disease occurring during treatment with Poteligeo)

  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 Outcomes (1)

• Change from baseline to after 8th administration in Global Response Score (GRS)

  Baseline (Day 1, prior to first dose) and Week 24 (after completion of 8th administration)

Interventions

Poteligeo 20mg DRUG

Poteligeo 20mg

Also known as: Mogamulizumab

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A person who has Mycosis fungoides and sezary syndrome.

You may qualify if:

• Adults 19 years of age or older
• 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
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kyowa Kirin Co., Ltd.: lead

Study Sites (6)

Kosin University Gospel Hospital

Busan, Busan Metropolitan City, 49267, South Korea

RECRUITING

Chung-Ang University Hospital

Seoul, South Korea

TERMINATED

Ewha Womans University Mokdong Hospital

Seoul, South Korea

RECRUITING

Samsung Medical Center

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Seoul National University Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Mycosis Fungoides; Sezary Syndrome

Interventions

mogamulizumab

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell, Cutaneous; Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• HaeMi Park

  Kyowa Kirin Korea Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

HaeMi Park

CONTACT

+82-10-3378-3471; haemi.park.m8@kyowakirin.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 20, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (6)