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

Interventional, Randomized, Double-blind, Parallel-group, Placebo-controlled, Dose-finding Trial of Lu AG09222 for the Prevention of Migraine in Participants With Unsuccessful Prior Preventive Treatments

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: Placebo; Drug: Lu AG09222

• Study Type: Interventional
• Enrollment (Actual): 874
• Phase: Phase 2

Contacts and Locations

Study Locations

• Bulgaria
  • Plovdiv, Bulgaria, 4000
    • MC Nevrocentrum
  • Plovdiv, Bulgaria, 4002
    • University Multiprofile Hospital for Active Treatment Sveti Georgi
  • Rousse, Bulgaria, 7000
    • MC Rusemed-OOD
  • Sofiiska
    • Sofia, Sofiiska, Bulgaria, 1680
      • Diagnostic Consultative Center Convex Ltd
• Czechia
  • Hradec Králové, Czechia, 500 03
    • Dr. Radomir Talab MD, Office of
  • Pilsen, Czechia, 30100
    • Neuros s.r.o
  • Prague, Czechia, 18600
    • Institut neuropsychiatricke pece
  • Prague, Czechia, 150 00
    • Praglandia s.r.o
  • Prague, Czechia, 100 00
    • Clintrial s. r. o.
  • Prague, Czechia, 12000
    • DADO Medical s.r.o.
  • Prague, Czechia, 15500
    • Axon Clinical s r.o
  • Prague, Czechia, 160 00
    • Neurologicka ordinace FORBELI sro
  • Slezská Ostrava, Czechia, 710 00
    • Neurologicka ambulance
  • Zlín, Czechia, 76001
    • NeuroMed Zlin s.r.o.
  • Pardubický kraj
    • Litomyšl, Pardubický kraj, Czechia, 57001
      • Neurosanatio s.r.o.
• Denmark
  • Copenhagen, Denmark, 2400
    • Bispebjerg Hospital - Region Capital
  • Glostrup Municipality, Denmark, 2600
    • Glostrup Hospital
• France
  • Bron, France, 69500
    • Centre Hospitalier Universitaire de Lyon, Hopital Pierre Wertheimer
  • Clermont-Ferrand Cedex1, France, 63003
    • Centre Hospitalier Universitaire de Clermont Ferrand - Gabriel Montpied
  • Lille, France, 59037
    • Centre Hospitalier Régional Universitaire de Lille - Hôpital Roger Salengro
  • Marseille, France, 13385
    • Assistance Publique Hopitaux de Marseille (AP-HM) - Hopital de La Timone
  • Paris, France, 75010
    • Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Lariboisiere
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Pierre-Paul Riquet
• Georgia
  • Tbilisi, Georgia, 0179
    • S. Khechinashvili University Hospital
  • Tbilisi, Georgia, 0159
    • JSC K. Eristavi National Center of Experimental and Clinical Surgery
  • Tbilisi, Georgia, 0160
    • Aversi Clinic
  • Tbilisi, Georgia, 0101
    • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
  • Tbilisi, Georgia, 0102
    • Caucasus Medical Center Ltd
  • Tbilisi, Georgia, 0159
    • Archangel St Michael Multiprofile Clinical Hospital
  • Tbilisi, Georgia, 0159
    • Jo Ann Medical Center
  • Tbilisi, Georgia, 0160
    • MD Georgia Staff Physician MediClub Georgia
• Germany
  • Berlin, Germany, 10117
    • Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
  • Böblingen, Germany, 71034
    • Studienzentrum Dr. Bischof GmbH
  • Ebersberg, Germany, 85560
    • Klinik Haag i. OB
  • Frankfurt, Germany, 65929
    • Headache Center Frankfurt
  • Hanover, Germany, 30449
    • Siteworks - Hannover
  • Heidelberg, Germany, 69115
    • Siteworks - Heidelberg
• Hungary
  • Tatabánya, Hungary, 2800
    • Komarom-Esztergom Varmegyei Szent Borbala Korhaz
  • Central Hungary (Közép-Magyarország)
    • Budapest, Central Hungary (Közép-Magyarország), Hungary, 1044
      • S-Medicon Kft.
• Japan
  • Tokyo, Japan, 160-8582
    • Keio University Hospital
  • Fukuoka
    • Kasuga-shi, Fukuoka, Japan, 816-0802
      • Jinnouchi Neurosurgery Clinic
    • Kasuga-shi, Fukuoka, Japan, 816-0824
      • Ikeda Neurosurgery Clinic
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 060-0061
      • Nakamura Memorial Hospital
  • Ibaraki
    • Mito, Ibaraki, Japan, 310-0015
      • Mito Kyodo General Hospital
  • Iwate
    • Morioka, Iwate, Japan, 020-8505
      • Iwate Medical University Uchimaru Medical Center
  • Kagoshima-ken
    • Kagoshima, Kagoshima-ken, Japan, 890-0052
      • Tanaka Neurosurgery & Headache Clinic
    • Kagoshima, Kagoshima-ken, Japan, 892-0842
      • Atsuchi Neurosurgical Hospital
  • Kanagawa
    • Fujisawa-shi, Kanagawa, Japan, 252-0816
      • Shonan Keiiku Hospital
  • Miyagi
    • Sendai, Miyagi, Japan, 982-0014
      • Sendai Headache and Neurology Clinic Medical Corporation
  • Osaka
    • Osaka, Osaka, Japan, 556-0017
      • Tominaga Hospital
  • Saitama
    • Iruma-gun, Saitama, Japan, 350-0495
      • Saitama Medical University Hospital
  • Shizuoka
    • Shizuoka, Shizuoka, Japan, 420-0853
      • Japanese Red Cross Shizuoka Hospital
  • Tochigi
    • Shimotsuga-Gun, Tochigi, Japan, 321-0293
      • Dokkyo Medical University Hospital
  • Tokyo
    • Minato-ku, Tokyo, Japan, 108-8642
      • Kitasato University Kitasato Institute Hospital
    • Minato-ku, Tokyo, Japan, 108-0075
      • Shinagawa Strings Clinic
• Lithuania
  • Kaunas, Lithuania, 50161
    • Hospital of Lithuanian University of Health Sciences Kaunas
  • Klaipėda, Lithuania, LT-92288
    • Klaipeda¿s University Hospital
  • Tauragė, Lithuania, 72250
    • Medicum Centrum
  • Vilnius, Lithuania, 08661
    • Vilniaus Universiteto Medicinos Fakultetas - Neurologijos ir Neurochirurgijos Klinika - Neurologi...
• Poland
  • Bydgoszcz, Poland, 85-796
    • Centrum Medczyne Pratia Bydgoszcz
  • Elblag, Poland, 82-300
    • Centrum Kliniczno-Badawcze J.Brzezicki, B.Gornikiewicz-Brzezicka Lekarze Spolka partnerska
  • Krakow, Poland, 30-727
    • Pratia MCM Kraków
  • Ksawerów, Poland, 95-054
    • Centrum Opieki Zdrowotnej OrkanMed
  • Lodz, Poland, 90-347
    • AppleTreeClinics Network Sp. z o.o.
  • Lublin, Poland, 20-701
    • Centrum Medyczne Hope Clinic Sebastian Szklener
  • Lublin, Poland, 20-064
    • Clinirem Sp. z o.o.
  • Lublin, Poland, 20-582
    • Indywidualna Praktyka Lekarska Dr hab. n. med. Anna Szczepanska-Szerej
  • Nowa Sól, Poland, 67-100
    • Twoja Przychodnia NCM
  • Oświęcim, Poland, 32-600
    • Instytut Zdrowia dr Boczarska-Jedynak
  • Plewiska, Poland, 62-064
    • Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Badan Klinicznych im. dr n. med. Hanki...
  • Sochaczew, Poland, 96-500
    • RCMed Oddzial Sochaczew
  • Warsaw, Poland, 02-172
    • MTZ Clinical Research Powered by Pratia
  • Wroclaw, Poland, 52-210
    • MIGRE Polskie Centrum Leczenia Migreny
  • Zabrze, Poland, 41-807
    • ClinHouse Centrum Medyczne
  • Greater Poland Voivodeship
    • Poznan, Greater Poland Voivodeship, Poland, 61-485
      • Centrum Medyczne HCP sp. z o.o
  • Lesser Poland Voivodeship
    • Krakow, Lesser Poland Voivodeship, Poland, 31-156
      • LANDA Specjalistyczne Gabinety Lekarskie
  • Masovian Voivodeship
    • Warsaw, Masovian Voivodeship, Poland, 01-684
      • Centrum Medyczne NeuroProtect
  • Silesian Voivodeship
    • Katowice, Silesian Voivodeship, Poland, 40-749
      • NEURO-CARE Sp. z o.o. Sp. Komandytowa
• Romania
  • Bucharest, Romania, 30463
    • Policlinica CCBR S.R.L.
  • Constanța, Romania, 900591
    • The Emergency County Clinical Hospital St. Andrew Constanta
  • Judet Arges
    • Campulung Muscel, Judet Arges, Romania, 115100
      • Sc Clubul Sanatatii S.R.L.
• Slovakia
  • Banská Bystrica, Slovakia, 974 04
    • Private Practice - Dr. Beáta Dupejová
  • Bardejov, Slovakia, 085 01
    • IN MEDIC s.r.o
  • Dubnica nad Váhom, Slovakia, 018 41
    • KONZILIUM s.r.o.
  • Prešov, Slovakia, 08001
    • SANERA, s.r.o.
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08035
    • Hospital Universitario Vall d'Hebron
  • Barcelona, Spain, 08003
    • Parc de Salut Mar - Hospital del Mar
  • Madrid, Spain, 28022
    • Clinica Universidad de Navarra
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra
  • Valencia, Spain, 46026
    • Hospital Universitario La Fe de Valencia
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia (Instituto de Investigacion Sanitaria Incliva)
• United States
  • Alabama
    • Hoover, Alabama, United States, 35244-5700
      • Accel Research Sites Network - Neurology and Neurodiagnostic of Alabama
  • California
    • Carlsbad, California, United States, 92011
      • Profound Research - Neurology Center of Southern California
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • Los Alamitos, California, United States, 90720
      • CenExel CNS
    • Sherman Oaks, California, United States, 91403
      • Asclepes Research Centers
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Ki Health Partners LLC DBA New England Institute for Clinical Research
  • Florida
    • Clermont, Florida, United States, 34711
      • K2 Medical Research - Winter Garden
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc.
    • Maitland, Florida, United States, 32751
      • K2 Medical Research, LLC - Maitland
    • Naples, Florida, United States, 34105
      • Aqualane Clinical Research
    • Tampa, Florida, United States, 33607
      • K2 Medical Research Tampa LLC
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute Palm Beach
  • Iowa
    • Ames, Iowa, United States, 50010
      • Accellacare and McFarland Clinic
  • Missouri
    • Chesterfield, Missouri, United States, 63005
      • Clinical Research Professionals
    • Hazelwood, Missouri, United States, 63042
      • Healthcare Research Network
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center, Inc.
    • Port Jefferson Station, New York, United States, 11776
      • North Suffolk Neurology, PC.
  • North Carolina
    • Cary, North Carolina, United States, 27518
      • Accellacare of Cary - Cary Medical Group
    • Greensboro, North Carolina, United States, 27405
      • Headache Wellness Center
    • Raleigh, North Carolina, United States, 27612
      • M3 Wake Research, Inc
    • Raleigh, North Carolina, United States, 27609
      • Raleigh Medical Group
    • Rocky Mount, North Carolina, United States, 27804
      • Accellacare of Rocky Mount
    • Winston-Salem, North Carolina, United States, 27103
      • Triad Neurological Associates
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
      • Accellacare of Charleston
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Internal Medicine and Pediatric Associates of Bristol, PC
  • Texas
    • Dallas, Texas, United States, 75251
      • Cedar Health Research, LLC
    • Sugar Land, Texas, United States, 77478
      • Mercury Clinical Research
  • Virginia
    • McLean, Virginia, United States, 22101
      • MedStar Health - Neurology Clinic at McLean

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group A: Placebo SC (closed for recruitment); Participants will receive 2 injections of placebo.	Drug: Placebo; Placebo matching to Lu AG09222 will be administered per the arm description
Experimental: Group B: Lu AG09222 SC (closed for recruitment); Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.	Drug: Placebo; Placebo matching to Lu AG09222 will be administered per the arm description; Drug: Lu AG09222; Lu AG09222 will be administered per the arm description.
Experimental: Group C: Lu AG09222 SC (closed for recruitment); Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.	Drug: Placebo; Placebo matching to Lu AG09222 will be administered per the arm description; Drug: Lu AG09222; Lu AG09222 will be administered per the arm description.
Experimental: Group D: Lu AG09222 SC (closed for recruitment); Participants will receive 1 injection of placebo and 1 injection containing Lu AG09222.	Drug: Placebo; Placebo matching to Lu AG09222 will be administered per the arm description; Drug: Lu AG09222; Lu AG09222 will be administered per the arm description.
Experimental: Group E: Lu AG09222 SC (closed for recruitment); Participants will receive 2 injections, each containing Lu AG09222.	Drug: Lu AG09222; Lu AG09222 will be administered per the arm description.
Placebo Comparator: Group F: Placebo IV; Participants will receive placebo by intravenous (IV) infusion.	Drug: Placebo; Placebo matching to Lu AG09222 will be administered per the arm description
Experimental: Group G: Lu AG09222 IV; Participants will receive Lu AG09222 by IV infusion.	Drug: Lu AG09222; Lu AG09222 will be administered per the arm description.
Experimental: Group H: Lu AG09222 IV; Participants will receive Lu AG09222 by IV infusion.	Drug: Lu AG09222; Lu AG09222 will be administered per the arm description.
Experimental: Group I: Lu AG09222 IV; Participants will receive Lu AG09222 by IV infusion.	Drug: Lu AG09222; Lu AG09222 will be administered per the arm description.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
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
Number of Participants with Anti-drug Antibodies (ADA)	Up to Week 20

Collaborators and Investigators

• Sponsor: H. Lundbeck A/S
• Investigators: Study Director: Email contact via H. Lundbeck A/S, H. Lundbeck A/S

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Actual): January 16, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: March 15, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Headache; Episodic Migraine; Chronic Migraine
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Migraine Disorders; Headache; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: 20297A; 2023-508821-28-00 (Other Identifier: EU Trial)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No