Risankizumab for Pediatric Psoriasis

(OptIMMize-2 Trial)

Recruiting at 53 trial locations

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Disqualifiers: Discontinuation criteria in M19-977

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 204 weeks

132 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Risankizumab for treating pediatric psoriasis?

Risankizumab has shown to be effective in treating moderate-to-severe plaque psoriasis in adults, with high rates of improvement in skin condition and quality of life. It has been approved in several countries for psoriasis and is being studied for other inflammatory conditions, suggesting its potential effectiveness in pediatric psoriasis as well. ^{1 2 3 4 5}

Is Risankizumab safe for treating psoriasis?

Risankizumab, also known as Skyrizi, has been generally well tolerated and considered safe in clinical trials for treating moderate-to-severe psoriasis. It has a favorable safety profile similar to other treatments like adalimumab and ustekinumab, with no serious safety issues reported in studies. ^{1 3 5 6 7}

How is the drug Risankizumab unique for treating pediatric psoriasis?

Risankizumab is unique because it targets a specific part of the immune system called interleukin-23 (IL-23), which plays a key role in psoriasis. It is a humanized antibody that offers a less frequent dosing schedule compared to other biologic treatments, making it a promising option for managing psoriasis. ^{1 3 5 8 9}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for kids aged 6-17 with moderate to severe plaque psoriasis who finished study M19-977. They can join if they meet the new study's requirements but not if they had reasons to stop participating in the previous study.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injection of risankizumab every 12 weeks

204 weeks

Regular visits at a hospital or clinic

Follow-up

Participants are monitored for safety after the last dose

20 weeks

Treatment Details

Interventions

• Risankizumab

Trial Overview The trial tests Risankizumab, an adult psoriasis drug, in children. It involves getting shots every 12 weeks for nearly four years and checks how well it works and its safety through medical exams, blood tests, side effects monitoring, and questionnaires.

Participant Groups

Group I: Risankizumab Experimental Treatment 1 Intervention

Participants will receive risankizumab subcutaneous (SC) injection every 12 weeks for 204 weeks.

Risankizumab is already approved in Canada, United States, European Union for the following indications:

Approved in Canada as Skyrizi for:

• Moderate-to-severe Crohn's disease

Approved in United States as Skyrizi for:

• Moderate-to-severe Crohn's disease
• Moderate-to-severe plaque psoriasis

Approved in European Union as Skyrizi for:

• Moderate-to-severe Crohn's disease
• Moderate-to-severe plaque psoriasis
• Psoriatic arthritis

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

Risankizumab-rzaa (Skyrizi®) is an effective treatment for moderate-to-severe psoriasis, as demonstrated in four pivotal Phase III trials involving adult patients, showing both efficacy and safety.

The drug works by targeting interleukin-23p19 (IL-23p19), a key player in the inflammatory process of psoriasis, which helps reduce the symptoms of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Risankizumab-rzaa in the Treatment of Plaque Psoriasis. Reddy, V., Yang, EJ., Myers, B., et al.[2020]

Risankizumab, a monoclonal antibody targeting IL-23, received its first global approval in March 2019 in Japan for treating various forms of psoriasis, including psoriasis vulgaris and psoriatic arthritis.

The drug is currently approved in multiple regions, including the USA and EU, for moderate-to-severe plaque psoriasis and is undergoing further clinical trials for other conditions like Crohn's disease and ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risankizumab: First Global Approval. McKeage, K., Duggan, S.[2020]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Risankizumab-rzaa in the Treatment of Plaque Psoriasis. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Long-term safety of risankizumab from 17 clinical trials in patients with moderate-to-severe plaque psoriasis. [2022]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Risankizumab: First Global Approval. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Long-term, durable, absolute Psoriasis Area and Severity Index and health-related quality of life improvements with risankizumab treatment: a post hoc integrated analysis of patients with moderate-to-severe plaque psoriasis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Risankizumab for the Treatment of Moderate to Severe Plaque Psoriasis. [2020]

6. England pubmed.ncbi.nlm.nih.gov

A drug safety evaluation of risankizumab for psoriasis. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Risankizumab for the treatment of moderate-to-severe psoriasis: A multicenter, retrospective, 1 year real-life study. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Emerging role of anti-IL23 in the treatment of psoriasis: When humanized is very promising. [2021]

9. Sweden pubmed.ncbi.nlm.nih.gov

Real-life Effectiveness and Safety of Risankizumab in Moderate-to-severe Plaque Psoriasis: A 40-week Multicentric Retrospective Study. [2022]