Johnson & Johnson reports positive Phase 3 mania results for CAPLYTA
- Study 452 tested once-daily lumateperone 42 mg against placebo for three weeks in adults with bipolar I mania.
- At Week 3, the YMRS score fell 3.7 points more with CAPLYTA than placebo (P<0.0001).
- Clinical response rates were 43.9% with CAPLYTA and 23.7% with placebo.
- The results, alongside positive findings from Study 451, will support a planned US regulatory submission.
Study results
Johnson & Johnson reported that Study 452, a global, randomized, double-blind Phase 3 trial, met its primary and key secondary endpoints. The study compared once-daily CAPLYTA (lumateperone) 42 mg with placebo over three weeks in adults with bipolar I manic episodes, with or without mixed features.
At Week 3, the reduction in Young Mania Rating Scale score was 3.7 points greater with CAPLYTA than with placebo (effect size −0.43; P<0.0001). Improvement was significant by Day 3 and sustained through Week 3. A clinical response—at least a 50% improvement in YMRS score—was reported in 43.9% of patients receiving CAPLYTA and 23.7% receiving placebo. The key secondary endpoint, improvement in Clinical Global Impression–Severity score, was also met.
Tolerability and regulatory plans
The company reported low discontinuation rates and a safety profile consistent with previous studies. The most common treatment-related adverse events occurring at least twice as often as with placebo and in at least 5% of CAPLYTA patients were dizziness, dry mouth and somnolence or sedation.
Combined with positive results from Study 451, the findings will support a planned US regulatory submission. CAPLYTA is not currently approved to treat manic episodes associated with bipolar I disorder.
Source: J&J