AbbVie (ABBV) announced positive top-line results from IMMhance, the fourth pivotal Phase 3 clinical trial evaluating risankizumab (150 mg) for the treatment of patients with moderate to severe plaque psoriasis.
According to the company, Risankizumab met all co-primary and ranked secondary endpoints in fourth pivotal Phase 3 study. No new safety signals were detected across the Phase 3 program for plaque psoriasis.
There were two phases in the Phase 3 study. Results from the first phase showed that after 16 weeks of treatment, risankizumab met the co-primary endpoints of at least a 90 percent improvement in the Psoriasis and Severity Index or PASI 90, and a static Physician Global Assessment or sPGA score of clear or almost clear versus placebo.
In the second phase of this study, the primary endpoint of sPGA 0/1 at week 52 (one year) was also met.
The company noted that the second phase (week 28 through 104) is evaluating the efficacy and safety of continuous therapy with risankizumab versus randomized withdrawal. Subsequently, retreatment is also being evaluated in this ongoing study.
Risankizumab is not approved by regulatory authorities and its safety and efficacy have not been established.
Results from IMMhance through week 16 were presented during an oral presentation at the 8th International Congress of Psoriasis from Gene to Clinic meeting in London on December 2.
Risankizumab is part of a collaboration with Boehringer Ingelheim, with AbbVie leading future development and commercialization of risankizumab globally.
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