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NCT05455931 · ClinicalTrials.gov registry record

Real World Observational Study of Poteligeo in Adult Patients With MF and SS (PROSPER)

A clinical trial of Mycosis Fungoides and Sézary Syndrome, sponsored by Kyowa Kirin Pharmaceutical Development.

Active
Registry status
73
Enrollment target
19
Study locations

NCT05455931: Active study of Mycosis Fungoides and Sézary Syndrome, sponsored by Kyowa Kirin Pharmaceutical Development.

NCT05455931 is a study of Mycosis Fungoides and Sézary Syndrome that is active but no longer recruiting, run by Kyowa Kirin Pharmaceutical Development. The registered enrollment target is 73 participants. The trial reports 19 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05455931, a study of Mycosis Fungoides and Sézary Syndrome, is active but no longer recruiting, sponsored by Kyowa Kirin Pharmaceutical Development.

ACTIVE NOT RECRUITING
Registry status
73 participants
Enrollment target
19
Study locations

Study Summary

This is a prospective, observational, non-interventional, international, multi-center, mixed methods study that will involve the integration of quantitative and qualitative data in patients with MF/SS treated with Poteligeo.

Primary Outcome

Patients will complete a symptom diary at regular intervals throughout the study to record symptoms including skin pain, skin itch, skin flaking, skin redness, difficulty regulating body temperature and sleep problems.

Interventions

  • DRUG Poteligeo

Study Locations (19)

Other

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Do Ancona - Ancona
  • IRCCS A.O.U. Policlinico S. Orsola - Malpighi - Bologna
  • Azienda Ospedaliero- Universitaria Careggi - Florence
  • Ematologia Policlinico di Milano - Milan
  • IFO-San Gallicano IRCCS - Rome
  • Universita Cattolica del Sacro Cuore - Policlinico Universitario Agostino Gemelli - Rome
  • Leids Universitair Medisch Centrum (LUMC) - Leiden
  • Hospital Del Mar - Barcelona
  • Hospital Universitari de Bellvitge - Barcelona
  • Sheikh Shakhbout Medical City - Abu Dhabi
  • Clatterbridge Hospital - Wirral University Teaching Hospital Nhs Foundation Trust - Bebington
  • University Hospital Birmingham - Birmingham
  • The Christie NHS Foundation Trust - Manchester
  • Nottingham University Hospitals NHS Trust - Nottingham City Hospital - Nottingham

Maryland

  • The Johns Hopkins University School of Medicine - Baltimore

Missouri

  • Washington University School of Medicine - St Louis

New York

  • Colombia University Medical Center - New York

Virginia

  • Inova Dwight and Martha Schar Cancer Institute - Fairfax

Washington

  • Fred Hutchinson Cancer Center - Seattle

Trial Details

FieldValue
Enrollment Target 73 participants
Start Date 2022-11-09
Est. Completion 2025-08-07

What the registry record for NCT05455931 still lists

NCT05455931 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 73 participants, a relatively small participant target.

The record links to 1 condition, with Mycosis Fungoides and Sézary Syndrome appearing as the primary indexed condition, and to 1 intervention - of which Poteligeo is the first listed.

NCT05455931 lists 19 locations in 6 states (Other, Maryland, Missouri).

Frequently Asked Questions

What is clinical trial NCT05455931 about?

NCT05455931 is a clinical study titled "Real World Observational Study of Poteligeo in Adult Patients With MF and SS (PROSPER)". This is a prospective, observational, non-interventional, international, multi-center, mixed methods study that will involve the integration of quantitative and qualitative data in patients with MF/SS treated with Poteligeo.

What is the current status of trial NCT05455931?

This trial is currently active not recruiting. The enrollment target is 73 participants. The study started on 2022-11-09. Estimated completion is 2025-08-07.

What conditions does trial NCT05455931 study?

This clinical trial studies the following conditions: Mycosis Fungoides and Sézary Syndrome.

What interventions are being tested in trial NCT05455931?

The interventions under investigation include: Poteligeo (DRUG).

Who is sponsoring clinical trial NCT05455931?

This trial is sponsored by Kyowa Kirin Pharmaceutical Development, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05455931 being conducted?

This trial has 19 study locations across Maryland, Missouri, New York, Virginia, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05455931, the US trial registry maintained by the National Library of Medicine. NCT05455931 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.