A Phase 3 interventional study of Risankizumab in Psoriasis, sponsored by AbbVie. Active, not recruiting at 41 sites in 7 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by AbbVie · Phase 3, Interventional, and Treatment
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study evaluates adverse events and change in disease activity with risankizumab in pediatric participants with moderate to severe plaque psoriasis who completed the study M19-977.
Risankizumab is an approved drug for treatment of moderate to severe plaque psoriasis in adults and is being studied in the pediatric population (6 to 17 years). A maximum of 132 participants will be enrolled in the study across approximately 50 sites worldwide.
Participants will receive subcutaneous injection of risankizumab every 12 weeks for 204 weeks and are followed up for safety for 20 weeks after last dose.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
1,899 studies on the registry are indexed under Psoriasis; 233 are open to participants now.
This study's planned enrollment of 132 is above the median of 70 across 1,447 interventional studies indexed under Psoriasis.
Browse Psoriasis studies →AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
--Participants who have completed participation in study M19-977 and who meet all eligibility criteria for participation in Study M19-973 will be allowed to enroll in study M19-973.
Exclusion Criteria:
--Participants who have developed any discontinuation criteria as defined in Study M19-977.
Participants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks.
Drug: Risankizumab
Subcutaneous (SC) injection.
Also known as: ABBV-066, BI 655066, SKYRIZI, risankizumab-rzaa
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above.
Time frame: Up to approximately 224 weeks
Plan to share: Yes — AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Supporting information: Study protocol, Sap, Csr
This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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