Clinical trial Recruiting at 9 sites Observational Ages 3 to 99

Study on the use of Koselugo for treating Neurofibromatosis 1

Official title: Real-World Treatment Study of Koselugo (Selumetinib)

Run by AstraZeneca · NCT06360406 · Data updated 2026-11-12

This study is testing how well Koselugo works and how safe it is for people with Neurofibromatosis 1 in everyday treatment settings in South Korea.

More Neurofibromatosis 1 trials

Quick facts

Study typeObservational
Ages3 Years to 99 Years
SexAll
Enrollment200 (estimated)
SponsorAstraZeneca
Industry-sponsored
Drugs / interventionsSelumetinib
Locations12 sites (Busan and 11 other locations)
StatusRecruiting
StartedJune 15, 2024
Main results expectedSeptember 30, 2031
Study endsSeptember 30, 2031
Registry record updatedAugust 25, 2026
Trial IDNCT06360406 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients diagnosed with Neurofibromatosis 1 who are receiving Koselugo treatment as per the approved label in South Korea.

Probably not a fit

Patients who are not being treated with Koselugo or those outside the approved treatment criteria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the safety and effectiveness of Koselugo (Selumetinib) in patients with Neurofibromatosis 1, specifically focusing on those treated in routine clinical practice settings in South Korea. It is part of a post-approval commitment by the Korean health authority to gather real-world data on the drug's performance. The study will assess known safety profiles and identify any previously unknown adverse reactions while providing insights into the treatment outcomes for the Korean patient population.

Why it matters

Potential benefit: If successful, this study could enhance understanding of Koselugo's safety and effectiveness, leading to improved treatment strategies for patients with Neurofibromatosis 1.

How similar studies have gone: While this study is focused on real-world data collection, similar studies assessing the effectiveness of targeted therapies have shown promising results in other contexts.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Patients treated with Koselugo (Selumetinib) under the approved label in South Korea
2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria:

1. Patients treated with Koselugo (Selumetinib) under the approved label in South Korea
2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Where it's running

  • Research Site
    Busan, South Korea
    Recruiting
  • Research Site
    Chungcheongbuk-do, South Korea
    Recruiting
  • Research Site
    Daejeon, South Korea
    Recruiting
  • Research Site
    Gyeonggi-do, South Korea
    Recruiting
  • Research Site
    Incheon, South Korea
    Recruiting
  • Research Site
    Jeonnam, South Korea
    Recruiting
Show 6 more locations
  • Research Site
    Seoul, South Korea
    Recruiting
  • Research Site
    Wŏnju, South Korea
    Recruiting
  • Research Site
    Yangsan, South Korea
    Recruiting
  • Research Site
    Seoul, South Korea
    Suspended
  • Research Site
    Seoul, South Korea
    Completed
  • Research Site
    Seoul, South Korea
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.