Safety and Tolerability of Tegoprubart in ALS Patients: A Phase 2A Clinical Trial
Study Overview
This study focused on the safety and tolerability of tegoprubart, an anti-CD40L antibody, in patients with amyotrophic lateral sclerosis (ALS). The goal was to understand how it affects inflammation in the body.
Key Findings
- Participants: 54 ALS patients received 6 infusions of tegoprubart every 2 weeks.
- Doses: Participants were divided into four groups based on the dose: 1 mg/kg, 2 mg/kg, 4 mg/kg, and 8 mg/kg.
- Completion Rate: 90.7% of participants completed the study.
- Common Side Effects: Fatigue (25.9%), falls (22.2%), headaches (20.4%), and muscle spasms (11.1%).
- Effectiveness: Tegoprubart showed a dose-dependent reduction in 18 pro-inflammatory biomarkers.
Conclusions
Tegoprubart was found to be safe and well-tolerated in adults with ALS. It reduced inflammation markers, suggesting potential for further studies to evaluate its effectiveness as a treatment.
Clinical Trial Registration
For more details, visit Clintrials.gov ID:NCT04322149.
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