Mycosis FungoidesNCT07132567
Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance
An observational study of Mycosis Fungoides and Sezary Syndrome, run by Kyowa Kirin Co., Ltd. at 6 sites in South Korea.
Trial summary
The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Mycosis Fungoides, Sezary Syndrome
- What is being tested?
- Poteligeo 20mg
- How many people
- 15 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 2 May 2025to Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A person who has Mycosis fungoides and sezary syndrome.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
South Korea6 sites, 5 recruiting
- Recruiting
Kosin University Gospel Hospital
Busan, Busan Metropolitan City, 49267
Kosin University Gospel Hospital hemato oncology, +82-51-990-6770, hs52silver@gmail.com
Ho Sup Lee
- Terminated
Chung-Ang University Hospital
Seoul
- Recruiting
Ewha Womans University Mokdong Hospital
Seoul
Ewha Womans University Mokdong Hospital hemato oncology, +82-2-2650-5063, yeungchul@ehwa.ac.kr
Yeungchul Moon
- Recruiting
Samsung Medical Center
Seoul
Samsung Medical Center hemato oncology, +82 2-3410-6856, kstwoh@skku.edu
SeokJin Kim
- Recruiting
Seoul National University Hospital
Seoul
Seoul National University Hospital hemato-oncology, +82 2 2072 0834, ihkimmd@snu.ac.kr
Kim in ho
- Recruiting
Seoul National University Hospital
Seoul
Seoul National University Hospital hemato-oncology, +82 2-2072-4990, go01@snu.ac.kr
Youngil Koh
About this study
The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.
Read the 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
- Conditions
- Mycosis Fungoides, Sezary Syndrome
- Being tested
- Poteligeo 20mg
- Keywords
- Poteligeo, mycosis fungoides, Sezary syndrome
- Medical subject headings
- Mycosis Fungoides, Sezary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Poteligeo 20mgDrug
Also called Mogamulizumab
Poteligeo 20mg
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: Baseline (Day 1, prior to first dose) and Week 24 (after completion of 8th administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start2 May 2025
- Primary completionSep 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mycosis FungoidesStudies of the same condition, open and under way.
- More trials run by Kyowa Kirin Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyejin Noh, Study director, Kyowa Kirin Korea Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132567
- Sponsor's protocol ID
- Poteligeo PMS
- Status last verified
- Oct 2026
- First submitted
- 22 Jul 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance
- ClinicalTrials.gov ID
- NCT07132567
- Acronym / sponsor ID
- Poteligeo PMS
- Conditions
- Mycosis Fungoides, Sezary Syndrome
- Keywords
- Poteligeo, mycosis fungoides, Sezary syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Kyowa Kirin Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 2 May 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A person who has Mycosis fungoides and sezary syndrome.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Poteligeo 20mgAlso: MogamulizumabPoteligeo 20mg | Drug | – |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Mycosis Fungoides
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A Prospective, US-based Study Assessing Mogamulizumab-associated Rash in Patients Diagnosed With Mycosis Fungoides or Sezary Syndrome and Treated With Standard of Care Mogamulizumab
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Duvelisib and Nivolumab for the Treatment of Stage IIB-IVB Mycosis Fungoides and Sezary Syndrome
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hyejin Noh study director
Kyowa Kirin Korea Co., Ltd.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mycosis Fungoides and Sezary Syndrome, run by Kyowa Kirin Co., Ltd. at 6 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hyejin Noh (+82-10-3378-3471, hyejin.noh.2u@kyowakirin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.