A Study to Investigate the Safety and Efficacy of MEDI0618 Compared to Placebo in Adult Participants With Episodic Migraine (AURORA)

A Phase 2, Randomised, Multicentre, Parallel-Group Treatment, Double-Blind Study to Investigate the Safety and Efficacy of Subcutaneous MEDI0618 in the Reduction of Migraine Headache Days Compared to Placebo in Adult Participants With Episodic Migraine

The purpose of this Phase 2 study is to evaluate the safety and efficacy of SC MEDI0618 compared to placebo in participants with episodic migraine.

Study Overview

• Status: Recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: MEDI0618; Drug: Placebo

Detailed Description

This Phase 2, randomised, multicentre, parallel-group treatment, double-blind, placebo -controlled study is designed to evaluate the safety and efficacy of subcutaneous (SC) MEDI0618 in participants with episodic migraine.

The study includes a cohort of participants who have a history of unsuccessful treatment with ≥ 2 small molecule migraine preventive treatments from different classes and are eligible to receive an aCGRP therapy (aCGRP-N) but have not yet done so; The study also includes a smaller cohort of participants who have failed one or more aCGRP therapies (aCGRP-IRs) used for preventative treatment and have a history of unsuccessful treatment with ≥ 2 small molecule migraine preventive treatments from different classes.

• Study Type: Interventional
• Enrollment (Estimated): 488
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• Czechia
  • Kladno, Czechia, 272 01
    • Not yet recruiting
    • Brain-Soultherapy s.r.o.
  • Prague, Czechia, 150 00
    • Recruiting
    • Praglandia s.r.o.
  • Prague, Czechia, 160 00
    • Recruiting
    • Forbeli s.r.o
  • Prague, Czechia, 100 00
    • Not yet recruiting
    • CLINTRIAL s.r.o.
  • Prague, Czechia, 150 00
    • Recruiting
    • Axon Clinical s.r.o.
  • Prague, Czechia, 120 00
    • Recruiting
    • DADO MEDICAL s.r.o.
  • Prague, Czechia, 186 00
    • Recruiting
    • Institut Neuropsychiatricke Pece (INEP)
  • Rychnov nad Kněžnou, Czechia, 266 55
    • Recruiting
    • Vestra Clinics s.r.o.
• Denmark
  • Glostrup Municipality, Denmark, 2600
    • Not yet recruiting
    • Rigshospitalet (Copenhagen University Hospital) - Dansk Hovedpinecenter (Danish Headache Center)
• Germany
  • Berlin, Germany, 10117
    • Not yet recruiting
    • Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM) - Klinik fuer Neurologie
  • Chemnitz, Germany, 09111
    • Recruiting
    • Pharmakologisches Studienzentrum Chemnitz GmbH
  • Dresden, Germany, 01307
    • Not yet recruiting
    • Universitätsklinikum Carl Gustav Carus Dresden
  • Essen, Germany, 45147
    • Not yet recruiting
    • Universitätsklinikum Essen
  • Frankfurt am Main, Germany, 65929
    • Not yet recruiting
    • Kopfschmerzzentrum Frankfurt
  • Westerstede, Germany, 26655
    • Not yet recruiting
    • Fachuebergreifende Gemeinschaftspraxis Dr. med. Joachim Springub & Wolfgang Schwarz
• Hungary
  • Budapest, Hungary, 1036
    • Recruiting
    • Óbudai Egészségügyi Centrum
  • Budapest, Hungary, 1138
    • Recruiting
    • S-Medicon Kft.
  • Dunaújváros, Hungary, 2400
    • Not yet recruiting
    • Obudai Egeszsegugyi Centrum - Dunaujvaros
• Italy
  • Milan, Italy, 20132
    • Not yet recruiting
    • Irccs Ospedale San Raffaele
  • Pavia, Italy, 27100
    • Not yet recruiting
    • IRCCS Fondazione Istituto Neurologico Nazionale Casimiro Mondino
  • Roma, Italy, 00163
    • Not yet recruiting
    • IRCCS San Raffaele Pisana
  • Roma, Italy, 00128
    • Not yet recruiting
    • Policlinico Universitario Campus Bio-Medico
• Poland
  • Bydgoszcz, Poland, 85-796
    • Recruiting
    • Centrum Medyczne Pratia Bydgoszcz
  • Katowice, Poland, 40-081
    • Recruiting
    • Centrum Medyczne Pratia - Katowice
  • Krakow, Poland, 30-539
    • Recruiting
    • Specjalistyczne Gabinety Sp. z o.o.
  • Krakow, Poland, 31-501
    • Recruiting
    • FutureMeds Sp. z.o.o.
  • Lublin, Poland, 20-701
    • Not yet recruiting
    • Centrum Medyczne Hope Clinic
  • Poznan, Poland, 60-529
    • Not yet recruiting
    • Solumed Centrum Medyczne
  • Poznan, Poland, 61-485
    • Recruiting
    • Centrum Medyczne HCP Sp. z o.o.
  • Warsaw, Poland, 00-215
    • Recruiting
    • FutureMeds Warszawa Centrum
  • Warsaw, Poland, 02-677
    • Recruiting
    • European Trial Group (ETG) - Warszawa
  • Warsaw, Poland, 02-172
    • Recruiting
    • MTZ Clinical Research Sp. z o.o.
• Spain
  • Badajoz, Spain, 06080
    • Not yet recruiting
    • Hospital Universitario de Badajoz
  • Barcelona, Spain, 08003
    • Not yet recruiting
    • Hospital del Mar
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
  • Madrid, Spain, 28046
    • Recruiting
    • Hospital Universitario La Paz
  • Valencia, Spain, 46010
    • Recruiting
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46026
    • Recruiting
    • Hospital Universitari i Politècnic La Fe
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Recruiting
      • Flourish - Birmingham
    • Huntsville, Alabama, United States, 35801
      • Withdrawn
      • Tennessee Valley Neurological Associates PC
  • California
    • La Jolla, California, United States, 92037
      • Recruiting
      • The Neurology Center of Southern California - Carlsbad Office
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Clinical Research Institute, LCC
  • Florida
    • Homestead, Florida, United States, 33033
      • Not yet recruiting
      • Homestead Associates in Research, Inc.
    • Lake Mary, Florida, United States, 32746
      • Not yet recruiting
      • Florida Neurology - Lake Mary
    • Miami, Florida, United States, 33135
      • Recruiting
      • Flourish Research - Miami, LLC DBA Flourish Research
    • St. Petersburg, Florida, United States, 33705
      • Not yet recruiting
      • BayCare Medical Group Neurology at St. Anthony's Hospital
    • Tampa, Florida, United States, 33615
      • Recruiting
      • Santos Research Center, Corp - Tampa
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Withdrawn
      • Norton Neuroscience Institute - Headache Clinic
  • New York
    • New York, New York, United States, 10001
      • Withdrawn
      • Modern Migraine, MD
  • Rhode Island
    • East Greenwich, Rhode Island, United States, 02818
      • Not yet recruiting
      • Velocity Clinical Research, Providence (East Greenwich)
  • South Carolina
    • Summerville, South Carolina, United States, 29486
      • Recruiting
      • Palmetto Primary Care Physicians Division of Gastroenterology - Summerville
  • Texas
    • Austin, Texas, United States, 78731
      • Recruiting
      • FutureSearch Trials
  • West Virginia
    • Crab Orchard, West Virginia, United States, 25827
      • Not yet recruiting
      • Vaught Neurological Services, PLLC
  • Wisconsin
    • Mequon, Wisconsin, United States, 53092
      • Recruiting
      • The Mind+ Neurology Clinic

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 18 to 70 years of age
• Weight ≥ 40 kg and BMI ≥ 18.0 kg/m2.
• History of migraine headaches with or without aura, with migraine onset at ≤ 50 years of age and for at least 12 months prior to screening.
• At least 12 MHDs over the last 3 months prior to screening.
• Participants must fulfil the following criteria for migraine in prospectively collected baseline information during the 4 consecutive weeks of baseline migraine headache data collection prior to Day 1: (a) ≥ 4 and ≤ 14 MHDs per month. (b) On ≥ 4 days, fulfils any of the following criteria: (i) migraine without aura; (ii) migraine with an aura symptom accompanied or followed by a headache within 60 minutes; (iii) probable migraine; (iv) recurrent attacks that do not match ICHD criteria for migraine but successfully respond to migraine-specific medication.
• Participants who fulfil criteria for MOH are eligible for this study.
• History of unsuccessful treatment with ≥ 2 small molecule migraine preventive treatments from different classes (a) aCGRP-N participants are eligible to receive an aCGRP therapy but must have not yet received aCGRP therapy for acute or preventive treatment at any time. (b) aCGRP-IR participants must have tried and have failed at least one aCGRP therapy used for preventive treatment.
• Participants must be able to distinguish migraine headaches from tension-type headaches.
• Female participants who are not pregnant and do not plan to become pregnant during the study, are not lactating, or are of nonchildbearing potential. FOCBP who are sexually active with a non-sterilised male partner must use adequate contraception consisting of two highly effective methods of contraception throughout the study. FOCBP must agree to comply with protocol specified guidance for safe administration of MEDI0618. FOCBP must refrain from egg donation and in vitro fertilisation from the time of signing the ICF, throughout the study, and for 10 weeks after the last administration of investigational product (IP).

Exclusion Criteria:

• History of migraine sub-types including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine
• History of headache other than migraine within 3 months prior to screening.
• History of severe or ongoing allergy/hypersensitivity reactions or history of hypersensitivity to immunisations or immunoglobulins.
• History of any significant psychiatric disorder which could be detrimental to participant safety or could compromise study data interpretation.
• Presence of any clinically significant illness, such as cardiovascular, neurologic (except for non-exclusionary headaches in participants with migraine), pulmonary, hepatic, renal, metabolic, gastrointestinal, urologic, immunologic, or endocrine disease or disorder.
• History of cancer within 5 years of screening, or between screening and randomisation, with the exception of non-metastatic basal cell carcinoma of the skin, carcinoma in situ of the cervix, or non-progressive prostate cancer.
• Known history of drug or alcohol abuse within 1 year of screening or positive test for drugs of abuse or alcohol at screening or at Day -1.
• History of QT prolongation > 450 msec (> 470 msec for participants aged ≥ 65 years) associated with other medications that required discontinuation of that medication.
• Congenital long or short QT syndrome.
• History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication are permitted.
• Use of migraine preventive medications within 30 days or 5 half-lives (whichever is longer) prior to screening and throughout the study
• For aCGRP-N participants only: prior use of an aCGRP therapy for acute or preventive treatment.
• Use of opioids or barbiturate containing analgesic > 2 times/month on average in the 6 months prior to screening for the treatment of pain (opioid administration in an emergency setting may be an exception).
• Use of botulinum toxin (e.g., Botox ®, Dysport®, Jeuveau™, Myobloc®, Xeomin®) for migraine or for any other medical or cosmetic reasons requiring injections in the head, face, or neck during the 4 months prior to screening.
• Use of an intervention or device (eg, scheduled nerve block, transcranial magnetic stimulation) for treatment of migraine within 2 months of screening.
• Use of prescription or non-prescription, non-biologic drugs, including vitamins and herbal and dietary supplements, within 7 days or 5 half-lives (whichever is longer) prior to screening and throughout the study unless the medication will not interfere with the study procedures or compromise participant safety; the dose and regimen must have been stable for at least 3 months prior to screening and must remain stable throughout the study.
• Requires treatment with another biological therapeutic agent including IV immunoglobulin treatment during the course of the study. Prior use of therapeutic antibodies is allowed if that use was > 5 half-lives of the intervention or 3 months prior to screening, whichever is longer.
• Therapeutic vaccines are permitted during the study, but ideally, live attenuated vaccines should be administered > 30 days prior to randomisation and inactivated vaccinations (eg, inactive influenza, COVID-19) should be administered > 14 days prior to randomisation.
• Participation in another clinical study with an IP, including an experimental vaccine, or device, within 5 half-lives of the intervention or 3 months prior to screening, whichever is longer.
• Known hypersensitivity to MEDI0618 or any of the excipients of the product.

Other protocol defined inclusion and exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aCGRP-N_MEDI0618 (Dose A); In the aCGRP-N cohort, 160 participants will be randomised on a 1:1 basis to receive MEDI0618 Dose A or placebo. After 104 participants total have been randomised, 3 other dose arms with MEDI0618 will be initiated and include 56 participants each.	Drug: MEDI0618; MEDI0618 per protocol
Placebo Comparator: aCGRP-N_Placebo; In the aCGRP-N cohort, 160 participants will be randomised on a 1:1 basis to receive MEDI0618 Dose A or placebo. After 104 participants total have been randomised, 3 other dose arms with MEDI0618 will be initiated and include 56 participants each.	Drug: Placebo; Volume-matched placebo for all arms
Experimental: aCGRP-N_MEDI0618 (Dose B); After 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 56 participants each on active dose arm.	Drug: MEDI0618; MEDI0618 per protocol
Experimental: aCGRP-N_MEDI0618 (Dose C); After 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 56 participants each on active dose arm.	Drug: MEDI0618; MEDI0618 per protocol
Experimental: aCGRP-N_MEDI0618 (Dose D); After 104 participants total have been randomised on Dose A and placebo arms, MEDI0618 will be initiated and include 56 participants each on active dose arm.	Drug: MEDI0618; MEDI0618 per protocol
Experimental: aCGRP-IR_MEDI0618 (Dose A); In the aCGRP-IR cohort there will be 1:1 randomisation of participants (80 to MEDI0618 and 80 to placebo).	Drug: MEDI0618; MEDI0618 per protocol
Placebo Comparator: aCGRP-IR_Placebo; In the aCGRP-IR cohort there will be 1:1 randomisation of participants (80 to MEDI0618 and 80 to placebo).	Drug: Placebo; Volume-matched placebo for all arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of repeat doses of MEDI0618 in preventing migraine headaches in patients with episodic migraine	Change in number of MHDs from 4-week baseline to last 4 weeks of treatment period.	Week 9 to Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of repeat doses of MEDI0618 in preventing migraine headaches in patients with episodic migraine as proportion of patients	Participants with at least 50% reduction in number of MHDs in the last 4 weeks of treatment period compared to 4-week baseline.	Week 9 to Week 12
Effect of repeat doses of MEDI0618 on disability caused by migraine headaches	Change in MIDAS score from baseline to end of treatment period and to follow-up.	Day 1 to Day 85 and to Day 141
Effect of repeat doses of MEDI0618 on disability caused by migraine headaches	Change in HIT-6 score from baseline throughout the treatment period and to follow-up	Day 1, Day 29, Day 57 and Day 85 and to Day 141
Effect of repeat doses of MEDI0618 on the severity of migraine headaches	Change in number of moderate or severe MHDs from 4-week baseline to last 4 weeks of treatment period.	Week 9 to Week 12
Effect of repeat doses of MEDI0618 on the severity of migraine headaches	Change in number of moderate or severe headache days from 4-week baseline to last 4 weeks of treatment period.	Week 9 to Week 12
Effect of repeat doses of MEDI0618 on the severity of migraine headaches	Change in frequency of use of permitted acute treatment to abort migraine headaches from 4-week baseline to last 4 weeks of the treatment period.	Week 9 to Week 12

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Estimated): December 18, 2026
• Study Completion (Estimated): May 7, 2027

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: September 16, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Episodic Migraine; MEDI0618; Migraine headache day(s) - MHD
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: D7060C00003; IND 170145 (Registry Identifier: FDA); 2024-512904-21 (Other Identifier: EMA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
• IPD Sharing Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• IPD Sharing Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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