Darvadstrocel in Patients With Crohn's Disease With Complex Perianal Fistulas: The ADMIRE CD II Phase 3 Randomized...

Area of Science:

• Gastroenterology
• Regenerative Medicine
• Clinical Trials

Background:

• The ADMIRE CD trial previously showed darvadstrocel efficacy for complex perianal fistulas.
• This study expanded the investigation to a larger, diverse patient population across North America, Europe, and Israel.

Purpose of the Study:

• To evaluate the efficacy and safety of darvadstrocel in an expanded population of patients with Crohn's disease and complex perianal fistulas.
• To assess combined remission rates at week 24 as the primary endpoint.

Main Methods:

• Phase 3, double-blind, randomized, placebo-controlled trial (ADMIRE CD II).
• Adults with Crohn's disease and complex perianal fistulas received either darvadstrocel or placebo post-curettage.
• Randomization was 1:1, with the primary endpoint being combined remission at week 24.

Main Results:

• Combined remission at week 24 was achieved in 48.8% of the darvadstrocel group versus 46.3% of the placebo group (P = .571).
• No statistically significant differences were observed in key secondary endpoints, including clinical remission.
• Adverse events were infrequent and occurred in similar proportions in both treatment arms.

Conclusions:

• ADMIRE CD II did not meet its primary endpoint, showing no significant difference between darvadstrocel and placebo for combined remission.
• Darvadstrocel demonstrated a comparable safety profile to placebo, with no new safety signals identified.