Brodalumab for Pediatric Psoriasis

Not currently recruiting at 4 trial locations

Overseen By Sandra Narain

Age: < 65

Sex: Any

Trial Phase: Phase 4

Sponsor: Bausch Health Americas, Inc.

Must not be taking: Systemic therapies

Disqualifiers: Pregnancy, Breastfeeding, Psoriasis treatment, others

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

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: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and metabolism of brodalumab, a monoclonal antibody, in children with psoriasis, a skin condition causing itchy, scaly patches. The study divides participants into two age-based groups: one receiving a 140 mg dose and the other a 70 mg dose. Children with long-standing psoriasis who haven't recently used certain treatments may qualify. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits more patients, contributing to broader knowledge about managing psoriasis in children.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you should not have received certain psoriasis treatments like conventional systemic therapies or phototherapy in the last 4 weeks. Topical corticosteroids are allowed.

What is the safety track record for Brodalumab?

Research has shown that brodalumab has been tested in adults with moderate to severe psoriasis. These studies indicate that it works quickly and effectively clears the skin. However, a safety concern exists regarding mental health, as there may be a link to an increased risk of suicidal thoughts.

Regarding overall safety, previous studies found that brodalumab is generally well-tolerated, with most side effects being mild to moderate. Common side effects include joint pain, headaches, and fatigue. It is important to discuss any concerns, especially about mental health, with a doctor before deciding to join a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for pediatric psoriasis, which often include topical corticosteroids and systemic medications, Brodalumab offers a novel approach by targeting the interleukin-17 receptor. This is significant because it directly interrupts a key pathway involved in the inflammatory process of psoriasis. Researchers are excited because Brodalumab's unique mechanism has the potential to provide faster and more effective relief for young patients, with the added benefit of being administered via a convenient subcutaneous injection.

What is the effectiveness track record for Brodalumab in treating pediatric psoriasis?

Research has shown that brodalumab can effectively treat moderate-to-severe plaque psoriasis in children and teens. In this trial, participants will be divided into two cohorts based on age. Cohort 1, ages 12 to <18 years, will receive a 140 mg SC dose of brodalumab, while Cohort 2, ages 6 to <12 years, will receive a 70 mg SC dose. One study found that 29.6% of patients saw their psoriasis symptoms reduced by 90%, and 55.5% experienced a 75% reduction by week 16. Another study found that patients with higher levels of brodalumab in their bodies had a median improvement of 93% in their symptoms. These results suggest that brodalumab can greatly reduce psoriasis symptoms in young patients. ^{6 7 8 9 10}

Who Is on the Research Team?

Varsha Bhatt

Principal Investigator

Bausch Health

Are You a Good Fit for This Trial?

This trial is for boys and girls aged 6 to less than 18 with psoriasis. They must have updated vaccinations, not be scheduled for new ones during the study, and girls of childbearing age must test negative for pregnancy and agree to use birth control.

Inclusion Criteria

My guardian has agreed to the study on my behalf because I am too young or unable to consent myself.

I am between 6 and 17 years old.

I am a woman who can have children and have tested negative for pregnancy.

Exclusion Criteria

I am willing to use effective birth control during and 5 weeks after the study.

I am not breastfeeding nor plan to while on the study and for 5 weeks after the last dose.

I have used treatments for psoriasis in the last 4 weeks, but topical steroids are okay.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of brodalumab to evaluate safety, tolerability, and pharmacokinetics

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Brodalumab

Trial Overview The study tests a single dose of Brodalumab in children with psoriasis. It's an open-label trial, meaning everyone knows they're getting the medication, to check its safety, how well it's tolerated, and how it moves through the body.

How Is the Trial Designed?

Group I: Cohort 2 Experimental Treatment 1 Intervention

(ages 6 to \<12 years): 70 mg SC dose of brodalumab

Group II: Cohort 1 Experimental Treatment 1 Intervention

(ages 12 to \<18 years): 140 mg SC dose of brodalumab

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

Approved in United States as Siliq for:

• Moderate to severe plaque psoriasis

Approved in European Union as Kyntheum for:

• Moderate to severe plaque psoriasis

Approved in Canada as Siliq for:

• Moderate to severe plaque psoriasis

Who Is Running the Clinical Trial?

Bausch Health Americas, Inc.

Lead Sponsor

Trials

265

Recruited

82,000+

Dr. Jonathan Sadeh

Bausch Health Americas, Inc.

Chief Medical Officer

MD from Mount Sinai School of Medicine, MSc in Clinical Research from Harvard Medical School

Thomas J. Appio

Bausch Health Americas, Inc.

Chief Executive Officer since 2021

Bachelor's degree in Biology from Rutgers University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04305327?tab=results

Efficacy and Safety of Brodalumab in Adolescents From 12 ... Efficacy and Safety of Brodalumab in Adolescents From 12 to 17 Years of Age With Moderate-to-severe Plaque Psoriasis (EMBRACE 1).

2. 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, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9569815/

Biological Treatments for Pediatric Psoriasis: State of the ... At week 16, 29.6% of patients achieved a 90% PASI score reduction, while 55.5% of patients achieved a 75% PASI score reduction, and effectiveness was sustained ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0190962219308606

Management of pediatric plaque psoriasis using biologics A treatment algorithm for moderate to severe plaque psoriasis in pediatric patients is presented, incorporating approved biologics.

5. mdedge.com mdedge.com/edermatologynews/article/255138/psoriasis/serum-brodalumab-levels-linked-treatment-outcomes-patients

Serum brodalumab levels linked with treatment outcomes ... Participants with quantifiable brodalumab levels (≥ 0.05 mcg/mL) showed a greater drop in PASI scores (median, 93%; range, 61%-100%) than those ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12275985/

Brodalumab for Moderate-to-Severe Psoriasis Clinical trial data consistently demonstrate its rapid onset of action, high rates of skin clearance, and durability of response. Real-world ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2017/761032Orig1s000MedR.pdf

761032Orig1s000 - accessdata.fda.gov DISCUSSION: Discuss the safety data for brodalumab. A. DISCUSSION: Do the safety data for brodalumab suggest a signal for: i. Suicide ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT01708629

NCT01708629 | Efficacy and Safety of Brodalumab ... This study assess the safety and efficacy of brodalumab at two different doses compared with placebo in participants with moderate to severe plaque psoriasis.

9. nejm.org nejm.org/doi/full/10.1056/NEJMoa1109017

Brodalumab, an Anti–Interleukin-17–Receptor Antibody for ... In this phase 2, randomized, double-blind, placebo-controlled, dose-ranging study, we assessed the efficacy and safety of brodalumab (AMG 827) ...

10. investors.amgen.com investors.amgen.com/news-releases/news-release-details/amgen-announces-moderate-severe-plaque-psoriasis-data-be

Amgen Announces Moderate-To-Severe Plaque Psoriasis ... ... psoriasis." Brodalumab data to be presented include an exploratory analysis of the Phase 2 trial evaluating efficacy and safety of brodalumab in moderate-to ...