OptIMMize-1

A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms

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. There is an unmet medical need for effective treatment in pediatric patients and this study is being done to evaluate risankizumab in pediatric participants with moderate to severe plaque psoriasis. This study will assess the change in disease symptoms. Risankizumab is a drug being studied for the treatment for plaque psoriasis in pediatric participants. This study has 4 parts. Part 1: Participants aged 12 < 18 will receive a fixed dose of risankizumab. Part 2: Participants aged 12 < 18 will receive; - Period A: Risankizumab or ustekinumab based on body weight followed by; - Period B: Risankizumab or no treatment. - Period C: Re-treatment with risankizumab (if needed). Part 3: Participants aged 6 < 12 will receive risankizumab based on body weight. Part 4: Participants aged 6 < 12 will receive risankizumab based on body weight (Japan only: Participants aged 12 > 18 will receive risankizumab based on body weight). Around 132 participants will be enrolled in approximately 50 sites worldwide. Risankizumab and ustekinumab are given as a subcutaneous (under the skin) injection. Parts 1, 3, and 4: Risankizumab for 40 weeks with a follow-up call 20 weeks later for a study duration of approximately 65 weeks. Part 2: - Period A: Risankizumab or ustekinumab for 16 weeks. - Period B: Risankizumab or no treatment for 36 weeks. - Period C: Re-treatment with risankizumab for 16 weeks. Follow-up call 20 weeks later for a study duration of approximately 81 weeks. Participants from each Part who meet eligibility criteria for an open-label extension (OLE) study may continue on risankizumab for 216 additional weeks. There may be a higher burden for study participants compared to standard treatment. Participants will attend monthly visits and medical assessments will check the effect of treatment through blood tests, questionnaires, and checking for side effects.

Interventional study

Status:
Completed
Conditions:
Psoriasis
Enrollment:
150 patients
Phase:
  • 1
  • 2
  • 3
  • 4
Protocol ID:
M19-977
Allocation:
Randomized
Intervention model:
Sequential Assignment
Masking:
Single (Outcomes Assessor)
Purpose:
Treatment

 

Eligibility criteria

Participant attributes:
Male and Female

Age:

From 6 Years to 17 Years.

Inclusion Criteria:

- Diagnosis of chronic plaque psoriasis for at least 6 months before the Baseline
Visit.

- Stable severe or moderate to severe plaque psoriasis as defined in each study part
by body surface area (BSA) psoriasis involvement and scores on the Psoriasis Area
and Severity Index (PASI) and Static Physician Global Assessment (sPGA).

- Candidate for systemic therapy as assessed by the investigator and meet the disease
activity criteria at both the Screening and Baseline Visits per the protocol.

Exclusion Criteria:

- Concurrent clinically significant medical conditions other than the indication being
studied or any other reason that the investigator determines would interfere with
the participant's participation in this study, would make the participant an
unsuitable candidate to receive study drug, or would put the participant at risk by
participating in the study.

All the cities where the clinical studies are located

St. John's - A1A 4Y3

Alberta

Newfoundland and Labrador

Ontario

Quebec

More information about this study

clinicaltrials.gov