OptIMMize-2

Study to Evaluate Adverse Events and Change in Disease Activity in Participants Between 6 and 17 Years With Moderate to Severe Plaque Psoriasis Treated With Subcutaneous (SC) Injection of Risankizumab Who Have Completed Participation in Study M19-977

Brief summary

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.

Interventional study

Status:
Enrolling by invitation
Conditions:
Psoriasis
Enrollment:
132 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M19-973
Allocation:
N/A
Intervention model:
Single Group Assignment
Masking:
None (Open Label)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 6 Years to 17 Years.

Inclusion Criteria:

--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.

All the cities where the clinical studies are located

St. John's - A1A 4Y3
Toronto - M5G 1X8
Montreal - H3T 1C5

Alberta

Newfoundland and Labrador

Ontario

Quebec

More information about this study

clinicaltrials.gov