Summary

Eligibility
for people ages 6-17 (full criteria)
Location
at UCSD
Dates
study started
completion around

Description

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.

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)

Keywords

Psoriasis, Plaque Psoriasis, Risankizumab, SKYRIZI, ABBV-066, BI 655066, Risankizumab-rzaa, Monoclonal Antibodies

Eligibility

You can join if…

Open to people ages 6-17

--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.

You CAN'T join if...

--Participants who have developed any discontinuation criteria as defined in Study M19-977.

Locations

  • University of California San Diego - Rady Children's Hospital San Diego /ID# 252348
    San Diego California 92123 United States
  • First OC Dermatology /ID# 226942
    Fountain Valley California 92708 United States
  • Integrative Skin Science and Research /ID# 226108
    Sacramento California 95815 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.
ID
NCT04862286
Phase
Phase 3 Psoriasis Research Study
Study Type
Interventional
Participants
Expecting 132 study participants
Last Updated