Clinical trial · Observational
Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance
NCT07132567CI-TRIAL-00095549recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this surveillance is to assess the safety and efficacy of Poteligeo Inj. 20 mg (mogamulizumab) in routine clinical settings.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mycosis Fungoides | Mycosis Fungoides | ONTOLOGY_EXACT | 0.98 |
| Sezary Syndrome | Sezary Syndrome | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Poteligeo 20mg | Drug | Mogamulizumab | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Safety (Special situation, adverse event, symptom, or disease occurring during treatment with Poteligeo)
- timeFrame
- From first administration of Poteligeo through 90 days after the last dose
- description
- 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 outcomes (1)
- measure
- Change from baseline to after 8th administration in Global Response Score (GRS)
- timeFrame
- Baseline (Day 1, prior to first dose) and Week 24 (after completion of 8th administration)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.