Biogen (BIIB) and its collaboration partner UCB said Tuesday their phase 3 trial evaluating dapirolizumab pegol in patients with moderate-to-severe systemic lupus erythematosus met its primary endpoint.
Results of the late-stage trial showed "significant clinical improvement" in disease activity in the subject patients, as well as a generally favorable safety profile, the companies said.
However, the trial failed to achieve statistical significance in the first secondary endpoint, they said. The companies plan to start a second phase 3 trial of the drug candidate in 2024.
Systemic lupus erythematosus is a chronic autoimmune disease affecting multiple organ systems, mainly in women.
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