In short
DESCARTES-08 is an investigational cell-based therapy being studied for generalized myasthenia gravis, a rare autoimmune condition that causes muscle weakness. One Phase 3 trial is authorised, with a planned enrollment of 119 participants, comparing DESCARTES-08 against placebo. The trial will measure whether treatment reduces symptoms on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale at Month 4.
Key points
- DESCARTES-08 is an investigational therapy given by intravenous infusion.
- The single authorised trial is a Phase 3 study in generalized myasthenia gravis.
- The trial is randomised, double-blind, and placebo-controlled.
- 119 participants are planned for enrollment.
- The main measure is a decrease of at least 3 points in MG-ADL score at Month 4.
What is DESCARTES-08?
DESCARTES-08 is an investigational substance being studied in a Phase 3 clinical trial for generalized myasthenia gravis, a chronic autoimmune disease in which the immune system attacks the connection between nerves and muscles, leading to weakness and fatigue. It is not yet described as an authorised medicine in the available trial record.
How does DESCARTES-08 work?
The available trial record does not describe the mechanism of action of DESCARTES-08 in detail. The trial is designed to evaluate its effect on symptoms of generalized myasthenia gravis, measured by the Myasthenia Gravis Activities of Daily Living (MG-ADL) score, which reflects how well a person can carry out everyday activities affected by muscle weakness.
Which conditions is DESCARTES-08 studied for?
- Generalized myasthenia gravis — a rare autoimmune condition causing weakness in voluntary muscles throughout the body, including those involved in breathing, swallowing, and movement.
How is DESCARTES-08 given?
DESCARTES-08 is given by intravenous use, meaning it is administered directly into a vein. The trial record lists the intervention as a drug for intravenous use.
What do the clinical trials show?
One clinical trial of DESCARTES-08 is authorised. It is a Phase 3, randomised, double-blind, placebo-controlled study in patients with generalized myasthenia gravis. The trial plans to enroll 119 participants.
The primary outcome measure is the proportion of participants who have a decrease of at least 3 points in MG-ADL score at Month 4 compared to Baseline, in the active group versus the placebo group. The MG-ADL scale assesses the impact of myasthenia gravis on daily activities such as speaking, chewing, swallowing, and breathing.
Who can take part in these trials?
The authorised trial is for patients with generalized myasthenia gravis. The trial record does not list further eligibility criteria such as age range or prior treatments.
What side effects are known?
The available sources do not provide information on side effects of DESCARTES-08.