Health
Add as a preferred source on GoogleThe Phase 3 trial tested adults with bipolar I disorder during mania, whether mixed features were present or absent.
Johnson & Johnson said Tuesday, Nov. 10, that Study 452 met its primary and key secondary endpoints in a Phase 3 CAPLYTA trial for adults with bipolar I mania.
The Phase 3 trial tested CAPLYTA in adults during a manic episode, including episodes with or without mixed features, the company said.
In its Nov. 10 announcement, Johnson & Johnson identified Study 452 as CAPLYTA’s second pivotal Phase 3 study to meet its trial goals in bipolar mania.
Johnson & Johnson said 49 of 163 Phase 2 participants completed 60-minute interviews; pooled, blinded responses captured perceived changes but cannot show the drug caused them.
The 12 responses came from 16 patients with measurable disease; the Phase 2 study began Sept. 16 and is recruiting.
At 50 mg once daily, 24 of 31 evaluable patients had a confirmed PSA decline of at least 50%; a separate imaging group had 11 responses among 16 patients.