KP-001 for Venous Malformations, Lymphatic Malformations, KTS/CLOVES Syndrome
This study is testing KP-001, an oral medication, against a placebo (an inactive pill) for people aged 2 and older with common venous malformations (VM), common lymphatic malformations (LM), or Klippel-Trenaunay Syndrome (KTS)/CLOVES syndrome. The main goal is to see how well KP-001 works and if it's safe. Success will be measured by changes in the size of the affected areas on MRI scans after 24 weeks. You might be able to join if your condition can't be cured by surgery or is difficult to remove. The study is currently recruiting participants.
- Study design
- This is a Phase 3, double-blind, randomized study comparing KP-001 to placebo, involving about 150 participants across multiple international sites.
- What's involved
- You would have a screening period of up to 42 days, followed by regular visits where vital signs, blood tests, and urine tests will be monitored for safety.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint is measured at 24 weeks post-dose, indicating follow-up for at least that long.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Investigate Efficacy and Safety of KP-001 Compared With Placebo in Patients Aged ≥2 Years With Common VM, Common LM, or KTS/CLOVES Syndrome
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- The ratio of volume of target lesions based on MRIpre-does and at 24weeks post-dose
To confirm the efficacy of KP-001 100 mg or lower based on body weight administered once daily in patients with vascular malformations (common VM, common LM, or KTS/CLOVES syndrome) in reducing volume of target lesions at 24 weeks