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Monoclonal Antibodies

Brodalumab for Pediatric Psoriasis

Phase 4
Recruiting
Research Sponsored by Bausch Health Americas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Males and females ages 6 to <18 years of age, inclusive, at the time of screening
Female subjects of childbearing potential must have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test at Baseline (Day 1). A female of childbearing potential is defined as a female who is fertile, following menarche.
Must not have
Female subjects who are pregnant or planning to become pregnant while on study through 5 weeks after receiving the dose of study drug.
Female subjects who have reached puberty and are sexually active and are unwilling to use acceptable methods of effective birth control for the duration of the study and continuing for 5 weeks after receiving the dose of study drug. Acceptable methods of effective birth control include sexual abstinence (males and females); double barrier method (male condom with spermicide in combination with one female barrier method [diaphragm, cervical cap, or contraceptive sponge)]; or hormonal birth control; or intra-uterine device.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 29 days
Awards & highlights
All Individual Drugs Already Approved
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will test the safety and tolerability of a new medication called brodalumab in children. It will also look at how this medication is processed by the body.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects of Brodalumab may include common cold symptoms, headache, fatigue, injection site reactions like redness or pain, diarrhea or nausea. More serious risks could involve infections or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 6 and 17 years old.
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I am a woman who can have children and have tested negative for pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not pregnant nor planning to become pregnant during the study and for 5 weeks after the last dose.
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I am willing to use effective birth control during and 5 weeks after the study.
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I am pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~29 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 29 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
maximum observed concentration (Cmax)

Side effects data

From 2019 Phase 4 trial • 210 Patients • NCT03331835
34%
Viral upper respiratory tract infection
13%
Headache
9%
Arthralgia
8%
Overdose
6%
Back pain
6%
Nausea
6%
Oropharyngeal pain
6%
Pruritus
5%
Fatigue
5%
Depressive symptom
4%
Diarrhoea
2%
Abdominal pain
2%
Abdominal pain upper
2%
Lymphopenia
1%
Reactive gastropathy
1%
Pancreatic carcinoma metastatic
1%
Stasis dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brodalumab 210 mg
Fumaric Acid Ester

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
(ages 6 to \<12 years): 70 mg SC dose of brodalumab
Group II: Cohort 1Experimental Treatment1 Intervention
(ages 12 to \<18 years): 140 mg SC dose of brodalumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brodalumab
FDA approved

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor
262 Previous Clinical Trials
81,914 Total Patients Enrolled
24 Trials studying Psoriasis
11,435 Patients Enrolled for Psoriasis
Anya LoncaricStudy DirectorBausch Health
39 Previous Clinical Trials
20,647 Total Patients Enrolled
4 Trials studying Psoriasis
3,842 Patients Enrolled for Psoriasis
Varsha BhattStudy DirectorBausch Health
8 Previous Clinical Trials
1,023 Total Patients Enrolled
2 Trials studying Psoriasis
90 Patients Enrolled for Psoriasis

Media Library

Brodalumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03240809 — Phase 4
Psoriasis Research Study Groups: Cohort 1, Cohort 2
Psoriasis Clinical Trial 2023: Brodalumab Highlights & Side Effects. Trial Name: NCT03240809 — Phase 4
Brodalumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03240809 — Phase 4
~3 spots leftby Nov 2025
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