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Monoclonal Antibodies

Brodalumab for Pediatric Psoriasis

Q: Are there any other empirical investigations involving Brodalumab?

As of now, there are seven ongoing clinical trials assessing the efficacy and safety of Brodalumab. Two of these studies have progressed to phase 3; they originate from Almere, RL Almere but span 105 different sites.

Q: Are there still openings in this clinical study?

Yes, the records on clinicaltrials.gov show that this experiment is in a current recruitment phase. It was initially posted on January 24th 2020 and its latest update occurred on September 7th 2022. 16 individuals are needed to take part at 5 distinct medical centres.

Q: Does this research involve participants aged 65 or older?

Our research indicates that this trial mainly seeks subjects aged 6 to 18. For minors or adults over 65, there are respectively 33 and 147 studies available for them.

Q: How many participants are currently enrolled in this experiment?

To begin the trial, 16 participants fulfilling the requirements must be enlisted. The two main locations for this study are Bausch Site 004 in Miami and Bausch Site 002 located in Henderson, NV.

Q: How many health care facilities are participating in this experiment?

Patients interested in this trial can access 5 designated sites, such as Bausch Site 004 located in Miami, or Bausch Site 002 based in Henderson; there are also 3 other sites found across Las Vegas and two additional locations.

Q: Does this investigation constitute a pioneering attempt?

Presently, 7 clinical trials for Brodalumab are running across 39 cities in 16 countries. This drug was first tested in 2017 by Kyowa Kirin Co., Ltd., with an initial sample size of 8 individuals and has since completed 20 studies. The original research concluded its Phase 1 approval stage that year.

Q: Am I eligible to participate in this clinical exploration?

This <a href="https://www.withpower.com/clinical-trials/psoriasis">psoriasis</a> trial requires 16 participants ranging from 6 to 18 years old. The minimum eligibility criteria for inclusion are as follows: gender neutrality, up-to-date immunizations relative to the country's regulations, and no scheduled vaccinations during the study period.

Q: Has the FDA given its blessing to Brodalumab?

Brodalumab has been approved, leading to a safety rating of 3 on our team's scale. This is due to the fact that Phase 4 trials are in progress for this medication.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 29 days

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am between 6 and 17 years old.

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 29 days

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

maximum observed concentration (Cmax)

Side effects data

From 2019 Phase 4 trial • 210 Patients • NCT03331835

34%

Viral upper respiratory tract infection

13%

Headache

Arthralgia

Overdose

Back pain

Nausea

Oropharyngeal pain

Pruritus

Fatigue

Depressive symptom

Diarrhoea

Abdominal pain upper

Abdominal pain

Lymphopenia

Reactive gastropathy

Pancreatic carcinoma metastatic

Stasis dermatitis

100%

80%

60%

40%

20%

Study treatment Arm

Brodalumab 210 mg

Fumaric Acid Ester

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bausch Health Americas, Inc.Lead Sponsor

262 Previous Clinical Trials

82,012 Total Patients Enrolled

24 Trials studying Psoriasis

11,541 Patients Enrolled for Psoriasis

Anya LoncaricStudy DirectorBausch Health

39 Previous Clinical Trials

20,815 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any other empirical investigations involving Brodalumab?

"As of now, there are seven ongoing clinical trials assessing the efficacy and safety of Brodalumab. Two of these studies have progressed to phase 3; they originate from Almere, RL Almere but span 105 different sites."

Answered by AI

Are there still openings in this clinical study?

"Yes, the records on clinicaltrials.gov show that this experiment is in a current recruitment phase. It was initially posted on January 24th 2020 and its latest update occurred on September 7th 2022. 16 individuals are needed to take part at 5 distinct medical centres."

Answered by AI

Does this research involve participants aged 65 or older?

"Our research indicates that this trial mainly seeks subjects aged 6 to 18. For minors or adults over 65, there are respectively 33 and 147 studies available for them."

Answered by AI

How many participants are currently enrolled in this experiment?

"To begin the trial, 16 participants fulfilling the requirements must be enlisted. The two main locations for this study are Bausch Site 004 in Miami and Bausch Site 002 located in Henderson, NV."

Answered by AI

How many health care facilities are participating in this experiment?

"Patients interested in this trial can access 5 designated sites, such as Bausch Site 004 located in Miami, or Bausch Site 002 based in Henderson; there are also 3 other sites found across Las Vegas and two additional locations."

Answered by AI

Does this investigation constitute a pioneering attempt?

"Presently, 7 clinical trials for Brodalumab are running across 39 cities in 16 countries. This drug was first tested in 2017 by Kyowa Kirin Co., Ltd., with an initial sample size of 8 individuals and has since completed 20 studies. The original research concluded its Phase 1 approval stage that year."

Answered by AI

Am I eligible to participate in this clinical exploration?

"This psoriasis trial requires 16 participants ranging from 6 to 18 years old. The minimum eligibility criteria for inclusion are as follows: gender neutrality, up-to-date immunizations relative to the country's regulations, and no scheduled vaccinations during the study period."

Answered by AI

Has the FDA given its blessing to Brodalumab?

"Brodalumab has been approved, leading to a safety rating of 3 on our team's scale. This is due to the fact that Phase 4 trials are in progress for this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects

2020. "An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03240809.

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