[M19-973] (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

JRCT ID: jRCT2041220091

Registered date:17/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Psoriasis
• Date of first enrollment: 16/11/2022
• Target sample size: 132
• Countries of recruitment: United States,Japan,Canada,Japan,Poland,Japan,Spain,Japan,United Kingdom,Japan,Germany,Japan
• Study type: Interventional
• Intervention(s): 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.

Outcome(s)

• Primary Outcome: Number of Participants With Adverse Events

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 17age old
• Gender: Both
• Include 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.
• Exclude criteria: Participants who have developed any discontinuation criteria as defined in Study M19-977.

Related Information

• Primary Sponsor: Fujimura Kimino
• Secondary ID(s): NCT04862286