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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03240809
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : September 30, 2021
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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

Condition or disease Intervention/treatment Phase
Psoriasis Biological: Brodalumab Phase 4

Detailed Description:
An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects (6 to < 18 Years Old) With Severe Plaque Psoriasis
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Brodalumab in Pediatric Subjects (6 to < 18 Years Old) With Severe Plaque Psoriasis
Actual Study Start Date : January 24, 2020
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Brodalumab

Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
(ages 12 to <18 years): 140 mg SC dose of brodalumab
 Biological: Brodalumab
140 mg SC dose
Experimental: Cohort 2
(ages 6 to <12 years): 70 mg SC dose of brodalumab
 Biological: Brodalumab
70 mg SC dose


Outcome Measures
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Primary Outcome Measures :
  1. maximum observed concentration (Cmax) [ Time Frame: 29 Days ]
    maximum (or peak) serum concentration that drug achieves in the body after drug has been administrated and prior to the administration of a second dose


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subject's parent(s) or legally acceptable representative has provided informed consent, using an Independent Ethics Committee (IEC) or Institutional Review Board (IRB) approved Informed Consent Form (ICF), when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated, or when the subject has any kind of condition that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
  2. Males and females ages 6 to <18 years of age, inclusive, at the time of screening
  3. Subjects must have up-to-date immunizations according to the relevant local country guideline. Subjects must not be scheduled to be vaccinated while on study.
  4. 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.

Exclusion Criteria:

  1. Received conventional systemic therapies or phototherapy for treatment of psoriasis within the last 4 weeks. Topical corticosteroids are allowed.
  2. 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.
  3. Female subjects who are lactating/breastfeeding or who plan to breastfeed while on study through 5 weeks after receiving the dose of study drug.
  4. Female subjects with a positive pregnancy test.
  5. Female subjects who are pregnant or planning to become pregnant while on study through 5 weeks after receiving the dose of study drug.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240809


Contacts
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Contact: Raquel Rojas 908.927.0643 Raquel.Rojas@bauschhealth.com

Locations
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United States, California
Bausch Site 003 Recruiting
San Diego, California, United States, 92123
United States, Florida
Bausch Site 002 Recruiting
Miami, Florida, United States, 33155
Bausch Site 004 Recruiting
Miami, Florida, United States, 33155
United States, Nevada
Bausch Site 005 Recruiting
Henderson, Nevada, United States, 89052
Bausch Site 001 Recruiting
Las Vegas, Nevada, United States, 45242
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Anya Loncaric Bausch Health
More Information
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT03240809    
Other Study ID Numbers: V01-BROA-401
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: September 30, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Brodalumab
 Antibodies, Monoclonal
Dermatologic Agents
Immunologic Factors
Physiological Effects of Drugs