Risankizumab for Pediatric Psoriasis

(OptIMMize-2 Trial)

Not currently recruiting at 64 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests risankizumab, a drug already used for adults, to determine its safety and effectiveness for children aged 6 to 17 with moderate to severe plaque psoriasis. Risankizumab reduces the inflammation that causes red, scaly skin patches. Participants will receive an injection every 12 weeks for nearly four years and must visit a hospital or clinic regularly for check-ups and tests. The trial seeks children who have completed a previous related study and continue to meet the eligibility criteria. Researchers will monitor participants for side effects and changes in their condition throughout the study. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a treatment nearing potential widespread use.

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.

Is there any evidence suggesting that risankizumab is likely to be safe for pediatric patients?

Research shows that risankizumab is generally safe and effective for treating moderate to severe plaque psoriasis in adults. Common side effects include mild headaches, fatigue, and injection site reactions. Although approved for adults, risankizumab is now being tested in children aged 6 to 17.

Earlier studies with adults reported mostly mild side effects, such as colds or skin reactions at the injection site. These are common with many medications and are usually not serious.

Since this trial is in a later stage, risankizumab has already demonstrated some safety in earlier tests. While side effects remain possible, current evidence supports its safety in treating psoriasis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for psoriasis?

Risankizumab is unique because it targets a specific part of the immune system called interleukin-23 (IL-23), which plays a crucial role in the inflammation associated with psoriasis. Unlike other treatments that might target broader immune pathways, such as those affecting both IL-12 and IL-23, risankizumab focuses solely on IL-23, potentially offering a more precise approach with fewer side effects. Additionally, it is administered as a convenient subcutaneous injection only once every 12 weeks, which could be a significant improvement in convenience and adherence compared to other treatments that require more frequent dosing. Researchers are excited about the potential for risankizumab to provide long-lasting relief with a tailored mechanism of action.

What is the effectiveness track record for risankizumab in treating moderate to severe plaque psoriasis in adults, and what evidence suggests it might be effective for pediatric psoriasis?

Research has shown that risankizumab effectively treats moderate to severe plaque psoriasis. In adults, studies have found that 81% of patients achieved much clearer skin after one year. Another study demonstrated that risankizumab significantly reduced the disease's severity over an extended period. Although this treatment is already approved for adults, the current trial tests its effectiveness in children aged 6 to 17. Early evidence suggests it may help reduce the thick, scaly patches caused by psoriasis in young patients. ^{1 2 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M19-977

A Study of Subcutaneous Risankizumab Injection for ... A study of subcutaneous Risankizumab injection for pediatric participants with moderate to severe plaque psoriasis to assess change in disease symptoms.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04862286

NCT04862286 | Study to Evaluate Adverse Events and ... This study evaluates adverse events and change in disease activity with risankizumab in pediatric participants with moderate to severe plaque psoriasis who ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12454820/

Real-World Effectiveness and Safety of Risankizumab in ... The results demonstrate that risankizumab is highly effective in reducing disease severity, as evidenced by a significant and sustained decrease ...

4. jaadreviews.org jaadreviews.org/article/S2950-1989(24)00062-X/fulltext

Pediatric psoriasis: Biologics and oral small molecule ... In children and adolescents with moderate-to-severe plaque psoriasis, etanercept significantly reduced disease severity (achieved PASI 50, 75, ...

5. skyrizihcp.com skyrizihcp.com/dermatology/psoriasis-efficacy

SKYRIZI® Efficacy In Moderate to Severe Plaque Psoriasis ... PASI 90 ACHIEVED BY 81% OF PATIENTS AT 1 YEAR · PASI 90 ACHIEVED BY 82% OF PATIENTS AT 1 YEAR · PASI 100 achieved by 60% of patients at 1 year · PASI 100 achieved ...

6. skyrizihcp.com skyrizihcp.com/dermatology/pso-psa-safety-profile

SAFETY PROFILE ESTABLISHED IN Ps AND PsA 1 Most common adverse reactions (≥1%) associated with SKYRIZI include upper respiratory infections, headache, fatigue, injection site reactions, and tinea ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10656860/

Management Strategies for Pediatric Moderate-to-Severe ... Reported data show significative clinical improvements in up to 96% of patients, reaching a complete skin clearance in about 50%, a percentage ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2019/761105Orig1s000MultidisciplineR.pdf

761105Orig1s000 - accessdata.fda.gov The safety data currently available demonstrate that risankizumab is safe for the treatment of moderate to severe plaque psoriasis in adult ...