Merck's tulisokibart meets primary endpoint in Phase 3 ATLAS-UC induction study for ulcerative colitis

Merck said its investigational antibody tulisokibart met the primary endpoint of clinical remission at week 12, measured by the Modified Mayo Score, in the Phase 3 ATLAS-UC induction-only study in moderately to severely active ulcerative colitis. Patients were randomized to high-dose or low-dose intravenous tulisokibart or placebo, and key secondary endpoints covered endoscopic improvement and histologic-endoscopic mucosal improvement. The release does not give remission rates, so the size of the effect is not yet known.

• Primary endpoint: clinical remission at week 12 (Modified Mayo Score)
• Induction-only study; high-dose and low-dose IV arms versus placebo
• Remission percentages and patient numbers are not stated in the release