A Study With Lu AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to learn whether a drug called Lu AG09222 can help prevent migraine headaches for people who have not been helped by other treatments that are used to prevent migraines. People who join this trial have tried 2 to 4 other medications to prevent their migraines, but these medications have not helped them. When the trial is over, researchers will use this information to find out if the number of migraine days decreased more for the participants who got either dose of Lu AG09222 than for the participants who got the placebo.

Detailed Description
-----------------
Participants will be randomly allocated to one of 3 treatment groups: Lu AG09222 high dose, Lu AG09222 low dose, or placebo, in a ratio of 2:1:2.

Official Title
-----------------
Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lu AG09222 for the Prevention of Migraine in Patients With Unsuccessful Prior Preventive Treatments

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: Lu AG09222
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: The participant has a diagnosis of migraine as defined by International Classification of Headache Disorders Third Edition (ICHD-3) guidelines confirmed at the Screening Visit. The participant has a history of migraine onset at least 12 months prior to the Screening Visit. The participant has a migraine onset at ≤50 years of age. The participant has documented evidence of treatment failure in the past 10 years of at least 2 to 4 (maximum) different migraine preventive medications. Key Exclusion Criteria: The participant has been previously dosed with an anti-pituitary adenylate cyclase-activating polypeptide (anti-PACAP) ligand-targeting antibody. The participant has confounding and clinically significant pain syndromes. The participant has a diagnosis of acute or active temporomandibular disorder. The participant has a history or diagnosis of confounding headaches.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lu AG09222 High Dose<br>Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion. | Drug: Lu AG09222<br>* Lu AG09222 will be administered per schedule specified in the arm.<br>|
| Experimental: Lu AG09222 Low Dose<br>Participants will receive a single low dose of Lu AG09222 by IV infusion. | Drug: Lu AG09222<br>* Lu AG09222 will be administered per schedule specified in the arm.<br>|
| Placebo Comparator: Placebo<br>Participants will receive a single dose of placebo matching to Lu AG09222 by IV infusion. | Drug: Placebo<br>* Placebo matching to Lu AG09222 will be administered per schedule specified in the arm.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in the Number of Monthly Migraine Days (MMDs) at Month 1 (Weeks 1-4) |  | Baseline, Month 1 (Weeks 1-4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With ≥50% Reduction From Baseline in MMDs |  | Baseline up to Month 1 (Weeks 1-4) | 
| Change From Baseline in the Number of Monthly Headache Days (MHDs) at Month 1 (Weeks 1-4) |  | Baseline, Month 1 (Weeks 1-4) |