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

Recruiting

• Conditions: Mycosis Fungoides, Sezary Syndrome

• Registration Number: NCT07132567
• Lead Sponsor: Kyowa Kirin Co., Ltd.

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 Timeline

• Study Start: 2025-05-02
• Study First Submitted: 2025-07-22
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-17
• Last Update Submitted: 2025-08-17
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Primary Completion: 2028-09
• Study Completion: 2028-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety (Special situation, adverse event, symptom, or disease occurring during treatment with Poteligeo)	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.

Secondary Outcome Measures

Name	Time	Method
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)	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.

Trial Locations

Locations (4)

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Ewha Womans University Mokdong Hospital; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of