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

• ClinicalTrials.gov Identifier: NCT05133323
• Recruitment Status: Completed
• First Posted: November 24, 2021
• Results First Posted: February 8, 2024
• Last Update Posted: March 13, 2024
• Sponsor: H. Lundbeck A/S
• Information provided by (Responsible Party): H. Lundbeck A/S

Tracking Information

• First Submitted Date: November 15, 2021
• First Posted Date: November 24, 2021
• Results First Submitted Date: January 15, 2024
• Results First Posted Date: February 8, 2024
• Last Update Posted Date: March 13, 2024
• Actual Study Start Date: November 11, 2021
• Actual Primary Completion Date: January 19, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 15, 2024)

Change From Baseline in the Number of Monthly Migraine Days (MMDs) [ Time Frame: Baseline, Week 4 ]

The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine and episodic migraine in adults. A Migraine Day was defined as a day with a headache that:

• lasts ≥4 hours and meets International Classification of Headache Disorders Third Edition (ICHD-3) guidelines criteria C and D for migraine without aura
• or lasts ≥30 minutes and where the participant had an aura with the headache (migraine with aura),
• or lasts ≥30 minutes and meets two of the three ICHD-3 criteria B (without the condition on 72 hours), C and D for migraine without aura (probable migraine),
• or a day with a headache that is successfully treated with a triptan, ergotamine, or other migraine-specific acute medication

• Original Primary Outcome Measures (submitted: November 15, 2021): Change From Baseline in the Number of Monthly Migraine Days (MMDs) at Month 1 (Weeks 1-4) [ Time Frame: Baseline, Month 1 (Weeks 1-4) ]

Current Secondary Outcome Measures (submitted: January 15, 2024)

• Percentage of Participants With ≥50% Reduction From Baseline in MMDs [ Time Frame: Baseline, Week 4 ]
  The Migraine Day definition was based on the International Headache Society (IHS) guidelines for controlled trials of preventive treatment of chronic migraine and episodic migraine in adults. A Migraine Day was defined as a day with a headache that:

  • lasts ≥4 hours and meets International Classification of Headache Disorders Third Edition (ICHD-3) guidelines criteria C and D for migraine without aura
  • or lasts ≥30 minutes and where the participant had an aura with the headache (migraine with aura),
  • or lasts ≥30 minutes and meets two of the three ICHD-3 criteria B (without the condition on 72 hours), C and D for migraine without aura (probable migraine),
  • or a day with a headache that is successfully treated with a triptan, ergotamine, or other migraine-specific acute medication
• Change From Baseline in the Number of Monthly Headache Days (MHDs) [ Time Frame: Baseline, Week 4 ]
  A Headache Day was defined as a day with a headache that lasted ≥30 minutes or that meets the definition of a Migraine Day.

Original Secondary Outcome Measures (submitted: November 15, 2021)

• Percentage of Participants With ≥50% Reduction From Baseline in MMDs [ Time Frame: 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) [ Time Frame: Baseline, Month 1 (Weeks 1-4) ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.
• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Migraine

Intervention

• Drug: Lu AG09222
  Lu AG09222 will be administered per schedule specified in the arm.
• Drug: Placebo
  Placebo matching to Lu AG09222 will be administered per schedule specified in the arm.

Study Arms

• Experimental: Lu AG09222 High Dose
  Participants will receive a single high dose of Lu AG09222 by intravenous (IV) infusion.
  Intervention: Drug: Lu AG09222
• Experimental: Lu AG09222 Low Dose
  Participants will receive a single low dose of Lu AG09222 by IV infusion.
  Intervention: Drug: Lu AG09222
• Placebo Comparator: Placebo
  Participants will receive a single dose of placebo matching to Lu AG09222 by IV infusion.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 7, 2023): 237
• Original Estimated Enrollment (submitted: November 15, 2021): 230
• Actual Study Completion Date: March 16, 2023
• Actual Primary Completion Date: January 19, 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Czechia, Denmark, Georgia, Poland, Slovakia, United States

Administrative Information

• NCT Number: NCT05133323
• Other Study ID Numbers: 19678A
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: H. Lundbeck A/S
• Original Responsible Party: Same as current
• Current Study Sponsor: H. Lundbeck A/S
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Email contact via H. Lundbeck A/S; H. Lundbeck A/S

• PRS Account: H. Lundbeck A/S
• Verification Date: March 2024