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Real-World study tracks Poteligeo's impact on rare skin cancer symptoms

NCT ID NCT05455931

Knowledge-focused Sponsor: Kyowa Kirin Pharmaceutical Development Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed observational study followed 73 adults with mycosis fungoides or Sézary syndrome who were starting treatment with Poteligeo. Researchers tracked changes in symptoms like itching, skin pain, and fatigue, as well as quality of life for patients and their caregivers. The goal was to understand how the drug works in everyday clinical practice, outside of a controlled trial setting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Poteligeo (mogamulizumab)
What this could lead to
If successful, this study could provide real-world evidence on how Poteligeo improves symptoms and quality of life for people with these rare skin lymphomas.
What could go wrong
This is an observational study, not a controlled trial, so results may be influenced by other factors. It is small (73 participants) and completed, so findings may not apply broadly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

73 people

The number who actually took part.

Started

Nov 2022

Finished

Aug 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Approximately 80 patients with a confirmed diagnosis of MF/SS and about to commence primary treatment with Poteligeo as per reimbursed indication will be recruited from approximately 19 sites across North America, United Arab Emirates and Europe.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient aged ≥18 years 2. Confirmed diagnosis of MF/SS 3. Disease staging at enrollment has been completed 4. About to commence primary treatment with Poteligeo® as per reimbursed indication 5. Patient is willing and able to complete the symptom diary and PROs. 6. Patient is willing and able to provide written informed consent to participate in the study in a manner approved by Institutional Review Board(IRB)/ Independent Ethics Committee (IEC) and local regulations Exclusion Criteria: 1. Patient unable to participate in all aspects of the study and/or does not agree to the collection of data from medical records 2. Patient currently participating in an interventional clinical trial

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Conditions

The condition(s) this trial relates to.

mycosis fungoides mycosis fungoides and variants Sezary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Mycosis fungoides and sézary syndrome

Contacts and locations

Locations

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona

    Ancona, Italy

  • Azienda Ospedaliero- Universitaria Careggi

    Florence, Italy

  • Clatterbridge Hospital - Wirral University Teaching Hospital Nhs Foundation Trust

    Bebington, United Kingdom

  • Colombia University Medical Center

    New York, New York, 10032, United States

  • Ematologia Policlinico di Milano

    Milan, Italy

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98105, United States

  • Hospital Del Mar

    Barcelona, Spain

  • Hospital Universitari de Bellvitge

    Barcelona, Spain

  • IFO-San Gallicano IRCCS

    Rome, Italy

  • IRCCS A.O.U. Policlinico S. Orsola - Malpighi

    Bologna, Italy

  • Inova Dwight and Martha Schar Cancer Institute

    Fairfax, Virginia, 22031, United States

  • Leids Universitair Medisch Centrum (LUMC)

    Leiden, Netherlands

  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital

    Nottingham, United Kingdom

  • Sheikh Shakhbout Medical City

    Abu Dhabi, Abu Dhabi Emirate, 11001, United Arab Emirates

  • The Christie NHS Foundation Trust

    Manchester, United Kingdom

  • The Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21205, United States

  • Universita Cattolica del Sacro Cuore - Policlinico Universitario Agostino Gemelli

    Rome, Italy

  • University Hospital Birmingham

    Birmingham, United Kingdom

  • Washington University School of Medicine

    St Louis, Missouri, 63108, United States