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

Lundbeck

Status and phase: Enrolling; Phase 2

Conditions: Migraine

Treatments: Drug: Placebo; Drug: Lu AG09222

Study type: Interventional

Funder types: Industry

Identifiers

NCT06323928

2023-508821-28-00 (Other Identifier)

20297A

Details and patient eligibility

About

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.

Enrollment: 845 estimated 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 ≥ 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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845 participants in 9 patient groups, including a placebo group

Group A: Placebo SC (closed for recruitment)

Placebo Comparator group

Description:

Participants will receive 2 injections of placebo.

Treatment:

Drug: Placebo

Group B: Lu AG09222 SC (closed for recruitment)

Experimental group

Description:

Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.

Treatment:

Drug: Lu AG09222

Drug: Placebo

Group C: Lu AG09222 SC (closed for recruitment)

Experimental group

Description:

Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.

Treatment:

Drug: Lu AG09222

Drug: Placebo

Group D: Lu AG09222 SC (closed for recruitment)

Experimental group

Description:

Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.

Treatment:

Drug: Lu AG09222

Drug: Placebo

Group E: Lu AG09222 SC (closed for recruitment)

Experimental group

Description:

Participants will receive 2 injections, each containing Lu AG09222.

Treatment:

Drug: Lu AG09222

Group F: Placebo IV

Placebo Comparator group

Description:

Participants will receive placebo by intravenous (IV) infusion.

Treatment:

Drug: Placebo

Group G: Lu AG09222 IV

Experimental group

Description:

Participants will receive Lu AG09222 by IV infusion.

Treatment:

Drug: Lu AG09222

Group H: Lu AG09222 IV

Experimental group

Description:

Participants will receive Lu AG09222 by IV infusion.

Treatment:

Drug: Lu AG09222

Group I: Lu AG09222 IV

Experimental group

Description:

Participants will receive Lu AG09222 by IV infusion.

Treatment:

Drug: Lu AG09222