Trial Profile
A Randomized, Active-Controlled, Efficacy Assessor-Blinded Study to Evaluate Pharmacokinetics, Safety and Efficacy of Risankizumab in Patients from 6 to Less than 18 Years of Age with Moderate to Severe Plaque Psoriasis
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 02 Jul 2026
Price :
$35
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At a glance
- Drugs Risankizumab (Primary) ; Ustekinumab (Primary)
- Indications Plaque psoriasis
- Focus Registrational; Therapeutic Use
- Acronyms OptIMMize-1
- Sponsors AbbVie; AbbVie Germany
Most Recent Events
- 26 Jun 2026 According to a AbbVie media release, Amy S. Paller is study investigator in the OptIMMize program.
- 26 Jun 2026 According to a AbbVie media release, based on data from the Phase 3 OptIMMize psoriasis clinical trial program (NCT04435600; NCT04862286), as well as population pharmacokinetic modeling and simulation based on well-controlled adult psoriatic arthritis studies, the U.S. FDA has approved SKYRIZI (risankizumab-rzaa) for the treatment of children six years of age and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy or active psoriatic arthritis.
- 23 Jun 2026 According to a AbbVie media release, the European Commission (EC) has approved SKYRIZI (risankizumab) for the treatment of children and adolescents six years of age and older with moderate to severe plaque psoriasis who are candidates for systemic therapy. Approval was based on the pivotal Phase 3 OptIMMize-1 and OptIMMize-2 trials which include a new 55 mg pre-filled syringe to support weight-based dosing for patients weighing less than 40 kg.