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

Lundbeck

Status and phase: Completed; Phase 2

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Lu AG09222

Study type: Interventional

Funder types: Industry

Identifiers

NCT05133323

19678A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 237 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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237 participants in 3 patient groups, including a placebo group

Lu AG09222 High Dose

Experimental group

Description:

Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion.

Treatment:

Drug: Lu AG09222

Lu AG09222 Low Dose

Experimental group

Description:

Participants will receive a single low dose of Lu AG09222 by IV infusion.

Treatment:

Drug: Lu AG09222

Placebo

Placebo Comparator group

Description:

Participants will receive a single dose of placebo matching to Lu AG09222 by IV infusion.

Treatment:

Drug: Placebo