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AbbVie’s psoriasis drug meets co-primary endpoints in three phase 3 trials

PBR Staff Writer Published 30 October 2017

AbbVie’s psoriasis drug risankizumab has met all co-primary and ranked secondary points in three pivotal phase 3 clinical trials.

The company has revealed positive top-line results from three pivotal phase 3 clinical trials assessing risankizumab compared to ustekinumab and adalimumab to treat patients with moderate to severe chronic plaque psoriasis.

Risankizumab is an investigational compound, which is designed to selectively block IL-23 by binding to its p19 subunit. Risankizumab has not yet secured approval from any regulatory authorities.

According to the company, results demonstrated that after 16 weeks of treatment, risankizumab (150 mg) met the co-primary endpoints of around 90% improvement in the psoriasis area and severity index (PASI 90) and a static physician global assessment (sPGA) score of clear or almost clear (sPGA 0/1) across all three studies versus placebo or adalimumab (based on trial design).1

AbbVie’s ultIMMa-1 and ultIMMa-2 are replicate Phase 3, randomized, double-blind, double-dummy, placebo- and active-controlled studies designed to assess the safety and efficacy of risankizumab compared to placebo or ustekinumab in adult patients with moderate to severe chronic plaque psoriasis.

In the trials, co-primary endpoints were achievement of about 90% improvement in the PASI score (PASI 90) at week 16 and achievement of a sPGA score of clear or almost clear (0/1) at week 16 compared to placebo.

The IMMvent study is a phase 3 randomized, double-blind, double-dummy and active-controlled study designed to assess the safety and efficacy of risankizumab compared to adalimumab in adult patients with moderate to severe chronic plaque psoriasis.

The trial’s co-primary endpoints were achievement of around 90% improvement in the PASI score (PASI 90) at week 16 and achievement of a sPGA score of clear or almost clear (0/1) at week 16.

AbbVie research and development executive vice president and chief scientific officer Dr Michael Severino said: "We are encouraged by these positive results for risankizumab. What is particularly exciting is the number of patients who achieved high rates of skin clearance in these three head-to-head clinical trials.”