A Dose-finding Trial With Lu-AG09222 in Adults With Migraine Who Have Not Been Helped by Prior Preventive Treatments

Phase 2

Recruiting

• Conditions: Migraine
• Interventions: Drug: Placebo; Drug: Lu AG09222

• Registration Number: NCT06323928
• Lead Sponsor: H. Lundbeck A/S

Brief Summary

The purpose of this trial is to determine which doses of Lu AG09222 are recommended to help prevent migraines. People who join this trial have already tried 1 to 4 other available medications to prevent their migraines, but these medications have not helped them.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-21
• Study Start: 2024-04-01
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-12
• Last Update Posted: 2025-06-15
• Primary Completion: 2026-02-28
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 898

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 ≥ 12 months prior to the Screening Visit.
• The participant has a migraine onset at ≤50 years of age.
• The participant has ≥4 migraine days per month for each month within the past 3 months prior to the Screening Visit.
• The participant has documented evidence of treatment failure in the past 10 years of at least 1 to 4 (maximum) different migraine preventive medications.

Key

Exclusion Criteria

• The participant has previously been dosed with an anti-pituitary adenylate cyclase-activating peptide (anti-PACAP treatment).
• 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.

Additional protocol-defined criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Placebo SC (closed for recruitment)	Placebo	Participants will receive 2 injections of placebo.
Group B: Lu AG09222 SC (closed for recruitment)	Lu AG09222	Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Group B: Lu AG09222 SC (closed for recruitment)	Placebo	Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Group C: Lu AG09222 SC (closed for recruitment)	Lu AG09222	Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Group C: Lu AG09222 SC (closed for recruitment)	Placebo	Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Group D: Lu AG09222 SC (closed for recruitment)	Lu AG09222	Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Group D: Lu AG09222 SC (closed for recruitment)	Placebo	Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.
Group E: Lu AG09222 SC (closed for recruitment)	Lu AG09222	Participants will receive 2 injections, each containing Lu AG09222.
Group F: Placebo IV	Placebo	Participants will receive placebo by intravenous (IV) infusion.
Group G: Lu AG09222 IV	Lu AG09222	Participants will receive Lu AG09222 by IV infusion.
Group H: Lu AG09222 IV	Lu AG09222	Participants will receive Lu AG09222 by IV infusion.
Group I: Lu AG09222 IV	Lu AG09222	Participants will receive Lu AG09222 by IV infusion.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in the Number of Monthly Migraine Days (MMDs)	Baseline up to Week 12 (Weeks 1-12)

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Anti-drug Antibodies (ADA)	Up to Week 20
Percentage of Participants With ≥75% Reduction From Baseline in MMDs	Baseline up to Week 12 (Weeks 1-12)
Change from Baseline in the Number of Monthly Headache Days	Baseline up to Week 12 (Weeks 1-12)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)	Up to Week 20
Change From Baseline in MMDs	Baseline up to Week 12 (Weeks 1-12)
Percentage of Participants With ≥50% Reduction From Baseline in MMDs	Baseline up to Week 12 (Weeks 1-12)

Trial Locations

Locations (108)

North Suffolk Neurology, PC.; 🇺🇸 Commack, New York, United States

Accel Research Sites Network - Neurology and Neurodiagnostic of Alabama; 🇺🇸 Hoover, Alabama, United States

Profound Research - Neurology Center of Southern California; 🇺🇸 Carlsbad, California, United States

Neurology Center of North Orange County; 🇺🇸 Fullerton, California, United States

CenExel CNS; 🇺🇸 Los Alamitos, California, United States

Asclepes Research Centers; 🇺🇸 Sherman Oaks, California, United States

New England Institute for Clinical Research (NEICR) - Stamford; 🇺🇸 Stamford, Connecticut, United States

K2 Medical Research - Winter Garden; 🇺🇸 Clermont, Florida, United States

Clinical Neuroscience Solutions, Inc.; 🇺🇸 Jacksonville, Florida, United States

K2 Medical Research, LLC; 🇺🇸 Maitland, Florida, United States

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