Dianthus Secures GO Decision After 20 Responders in CIDP Trial
Dianthus achieved an early GO decision in its Phase 3 CAPTIVATE trial after confirming 20 responders in under 40 CIDP patients, with the DSMB reporting no related serious infections. The company will maintain a 300mg/2mL Q2W dose, plans to enroll 256 patients and randomize 128 in Part B.
1. Phase 3 Trial GO Decision
Dianthus announced an early GO decision in its CAPTIVATE Phase 3 trial for claseprubart in CIDP after interim analysis confirmed 20 responders among fewer than 40 participants. The independent DSMB review cited no study-related serious infections or adverse events, supporting continued development.
2. Trial Design and Next Steps
The company will maintain the 300mg/2mL Q2W dosing regimen and remove the 600mg/4mL arm, engaging regulators to streamline the protocol. Part A is set to enroll up to 256 patients, followed by randomization of 128 subjects into Part B to confirm efficacy.
3. Financial Position and Runway
As of December 31, 2025, Dianthus held $514.4 million in cash, providing funding into 2028. Shares have risen over 160% in the past 12 months and trade significantly above their 20-day and 100-day moving averages, reflecting strong investor confidence.