Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04862286
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-17
First Post:
2021-04-26
Brief Title:
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
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
OptIMMize-2 A Phase 3 Multicenter Single-arm Open-label Extension Study to Assess the Safety Tolerability and Efficacy of Risankizumab in Subjects With Moderate to Severe Plaque Psoriasis Who Have Completed Participation in Study M19-977 OptIMMize-1
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OptIMMize-2
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-500408-22-00 | OTHER | EU CT | None |