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NCT06541847 · ClinicalTrials.gov registry record · Phase 2
A Phase 2, Open-Label Study to Evaluate the Safety and Effects of HLX-1502 in Patients With Neurofibromatosis Type 1
A Phase 2 study of Neurofibromatosis Type 1, sponsored by Healx Limited.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 13
- Study locations
NCT06541847: Recruiting Phase 2 study of Neurofibromatosis Type 1, sponsored by Healx Limited.
NCT06541847 is a Phase 2 study of Neurofibromatosis Type 1 that is actively recruiting participants, run by Healx Limited. The registered enrollment target is 25 participants, below the 159-participant average among 17 other Neurofibromatosis Type 1 trials with a reported enrollment target (84% lower). The trial reports 13 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06541847, a Phase 2 study of Neurofibromatosis Type 1, is actively recruiting participants, sponsored by Healx Limited.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 13
- Study locations
Study Summary
The trial will be an open label, single arm, phase 2 study to assess the tolerability and efficacy of HLX-1502 in participants with NF1 that are 16 years or older in age with progressive and/or symptomatic PN. This study will also investigate the safety and efficacy of HLX-1502 in a small cohort of 12 to 15 year olds.
Primary Outcome
Response will be determined by a blinded centralized review of volumetric MRI. A partial response (PR) is defined as ≥ 20% decrease in the volume of target PN.
Conditions Studied
Interventions
- DRUG HLX-1502
Study Locations (13)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
- University of Chicago - Chicago
Alabama
- University of Alabama at Birmingham - Birmingham
California
- Children's Hospital Los Angeles - Los Angeles
Colorado
- Children's Hospital Colorado - Aurora
District of Columbia
- Children's National Hospital - Washington D.C.
Indiana
- Indiana University - Indianapolis
Maryland
- Johns Hopkins Hospital - Baltimore
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2025-02-10 |
| Est. Completion | 2028-01 |
| Phase | Phase 2 |
What NCT06541847 shows while recruiting
NCT06541847 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 159-participant average among 17 other Neurofibromatosis Type 1 trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Neurofibromatosis Type 1 appearing as the primary indexed condition, and to 1 intervention - of which HLX-1502 is the first listed.
NCT06541847 lists 13 locations in 12 states (Illinois, Alabama, California).
Frequently Asked Questions
What is clinical trial NCT06541847 about?
NCT06541847 is a clinical study titled "A Phase 2, Open-Label Study to Evaluate the Safety and Effects of HLX-1502 in Patients With Neurofibromatosis Type 1". The trial will be an open label, single arm, phase 2 study to assess the tolerability and efficacy of HLX-1502 in participants with NF1 that are 16 years or older in age with progressive and/or symptomatic PN. This study will also investigate the safety and efficacy of HLX-1502 in a small cohort of ...
What is the current status of trial NCT06541847?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2025-02-10. Estimated completion is 2028-01.
What conditions does trial NCT06541847 study?
This clinical trial studies the following conditions: Neurofibromatosis Type 1.
What interventions are being tested in trial NCT06541847?
The interventions under investigation include: HLX-1502 (DRUG).
Who is sponsoring clinical trial NCT06541847?
This trial is sponsored by Healx Limited, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06541847 being conducted?
This trial has 13 study locations across Alabama, California, Colorado, District of Columbia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06541847's enrollment target sits among peer trials
25 14th of 17 higher than 4 of 17 other Neurofibromatosis Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neurofibromatosis Type 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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