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news.AbbVie’s psoriasis drug risankizumab (150 mg) has met all the primary endpoints in the two phases of a fourth pivotal phase 3 clinical trial in patients with moderate to severe plaque psoriasis.
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The investigational compound, which has been designed to selectively inhibit IL-23 by binding to its p19 subunit, was evaluated in the late-stage study dubbed IMMhance,
In the first phase of the study, risankizumab met the co-primary endpoints after 16 weeks of treatment.
The primary endpoints of the first phase are at least a 90% improvement in the Psoriasis and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) in comparison to placebo.
Risankizumab met the primary endpoint in the second phase of this study as well, which was defined to be sPGA 0/1 at week 52.
The second phase, which was carried from week 28 to 104, studied the efficacy and safety of continuous treatment with risankizumab in comparison to randomized withdrawal of the psoriasis drug. Subsequently, retreatment is also being assessed in this ongoing study, stated AbbVie.
The company also revealed that the safety profile in IMMhance was on par with the data reported from previous phase 3 clinical trials, with no new safety signals observed across the phase 3 study.
Risankizumab is yet to be approved by drug regulators for its desired indication while its safety and efficacy have not been established.
The investigational treatment is part of a collaboration between AbbVie and Boehringer Ingelheim. AbbVie had taken up the task of leading future development and global commercialization of risankizumab.
AbbVie research and development executive vice president and chief scientific officer Michael Severino said: “These positive results are consistent with the previous data we have seen with risankizumab throughout the pivotal Phase 3 clinical trial program.
“With a significant portion of risankizumab patients achieving high levels of skin clearance, these results add to the data supporting risankizumab's potential to be an impactful new treatment option for patients living with psoriasis.”
Image: AbbVie Corporate Headquarters. Photo: courtesy of AbbVie Inc.
