A Study in Children and Young People With Migraine to Learn What the Body Does to Eptinezumab

Study Overview
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Brief Summary
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The purpose of the study is to investigate how the body absorbs, distributes, and get rid of eptinezumab when given directly into a vein.

Detailed Description
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This is an interventional, open-label pharmacokinetic study with eptinezumab, consisting of a single-dose, 20-week main study period (Part A) and an optional 44-week multiple-dose extension period (Part B). The main study period includes a single IV infusion of eptinezumab. The optional extension period includes 3 additional eptinezumab infusions 12 weeks apart (reflecting recommended dosing interval in adults), for a total of up to 4 infusions over the course of the study. At least 32 patients with migraine will be enrolled: 16 patients aged 6 to 11 years, and 16 patients aged 12 to 17 years, inclusive.

Official Title
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An Open-label, Single-dose, Pharmacokinetic Study to Evaluate IV Eptinezumab in Children and Adolescents With Migraine, Followed by an Optional, Multiple-dose, Open-label Extension Period

Conditions
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Migraine in Children, Migraine

Intervention / Treatment
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* Drug: Eptinezumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient has a diagnosis of migraine with or without aura according to international classification of headache disorders (ICHD)-3 (in the opinion of the investigator) for ≥6 months prior to the Screening Visit and has a frequency of migraine ≥4 migraine days per month for at least 3 months prior to the Screening Visit. Exclusion Criteria: The patient has been exposed to any monoclonal antibody treatment (including exposure in a study) <6 months prior to the Screening Visit. Other in- and exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eptinezumab<br> | Drug: Eptinezumab<br>* up to four iv infusions of eptinezumab<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under curve (AUC) (0-infinity) eptinezumab | Area under the plasma concentration curve for eptinezumab from zero to infinity | From dosing to week 20 | 
| Cmax eptinezumab | Maximum observed plasma concentration of eptinezumab | From dosing to week 20 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance (CL) | Plasma clearance | From dosing to week 20 | 
| Volume of distribution (Vz) |  | From dosing to week 20 | 
| Development of anti-eptinezumab antibodies (ADA) |  | From screening to week 12 | 
| Characterization of anti-eptinezumab antibodies for neutralizing activity (NAb) |  | From screening to week 12 |