Clinical trial • Phase II • Neurology
MEDI0618 for Migraine | Episodic migraine
Phase II trial of MEDI0618 for Migraine | Episodic migraine.
Overview
- Trial Therapeutic Area
- Neurology
- Trial Disease
- Migraine | Episodic migraine
- Trial Stage
- Phase II
- Drug Modality
- Peptide/protein/enzyme
Key dates
- Initial CTIS Submission Date
- 29-07-2024
- First CTIS Authorization Date
- 19-11-2024
Trial design
Randomised, placebo to match medi0618 (placebo arm). dose and schedule not specified in the ctis metadata.-controlled Phase II trial in Poland, Denmark, Germany and others.
- Randomised
- Yes
- Comparator
- Placebo to match MEDI0618 (placebo arm). Dose and schedule not specified in the CTIS metadata.
- Target Sample Size
- 772
- Trial Duration For Participant
- 112
Eligibility
Recruits 772 CTIS metadata indicates isVulnerablePopulationSelected = true. Subject information and informed consent forms are provided for adult participants and specific materials for pregnant partners (examples: L1_SIS and ICF_Main, L1_SIS and ICF_Pregnancy, L1_SIS and ICF_Pregnant Partner). Consent is obtained from participants (adult participants); no assent procedures for minors are provided (study includes adults aged 18–70)..
- Pregnancy Exclusion
- 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 one highly effective method of contraception throughout the study. FOCBP must agree to comply with protocol specified guidance for safe administration of MEDI0618.
- Vulnerable Population
- CTIS metadata indicates isVulnerablePopulationSelected = true. Subject information and informed consent forms are provided for adult participants and specific materials for pregnant partners (examples: L1_SIS and ICF_Main, L1_SIS and ICF_Pregnancy, L1_SIS and ICF_Pregnant Partner). Consent is obtained from participants (adult participants); no assent procedures for minors are provided (study includes adults aged 18–70).
Inclusion criteria
- {"criterion_text":"- 18 to 70 years of age\n- Weight ≥ 40 kg and BMI ≥ 18.0 kg/m2.\n- 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.\n- At least 12 MHDs over the last 3 months prior to screening.\n- 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.\n- Participants who fulfil criteria for MOH are eligible for this study.\n- 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 at any time. (b) aCGRP-IR participants must have tried and have failed at least one aCGRP therapy.\n- Participants must be able to distinguish migraine headaches from tension-type headaches.\n- 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 one highly effective method of contraception throughout the study. FOCBP must agree to comply with protocol specified guidance for safe administration of MEDI0618."}
Exclusion criteria
- {"criterion_text":"- 1. History of migraine sub-types including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and basilar-type migraine\n- 15. Use of an intervention or device (eg, scheduled nerve block, transcranial magnetic stimulation) for treatment of migraine within 2 months of screening.\n- 16. 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.\n- 18. 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.\n- 17. 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.\n- 2. History of headache other than migraine within 3 months prior to screening.\n- 3. History of severe or ongoing allergy/hypersensitivity reactions or history of hypersensitivity to immunisations or immunoglobulins.\n- 4. History of any significant psychiatric disorder which could be detrimental to participant safety or could compromise study data interpretation.\n- 5. 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 which could be detrimental to participant safety or could compromise study data interpretation.\n- 6. 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.\n- 7. 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.\n- 9. Congenital long or short QT syndrome.\n- 8. History of QT prolongation > 450 msec (> 470 msec for participants aged ≥ 65 years) associated with other medications that required discontinuation of that medication.\n- 19. 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.\n- 10. 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.\n- 20. Known hypersensitivity to MEDI0618 or any of the excipients of the product.\n- 11. Use of migraine preventive medications within 30 days or 5 half-lives (whichever is longer) prior to screening and throughout the study\n- 12. For aCGRP-N participants only: prior use of an aCGRP therapy.\n- 13. 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).\n- 14. Use of botulinum toxin 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."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change in number of MHDs from 4-week baseline to last 4 weeks of treatment period (Week 9 to Week 12)","definition_or_measurement_approach":"Change in number of migraine headache days (MHDs) from a prospectively collected 4-week baseline period to the last 4 weeks of the treatment period (Week 9 to Week 12)."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 772
- Recruitment Window Months
- 26
- Consent Approach
- Informed consent is obtained from each adult participant using subject information and informed consent forms (L1_SIS and ICF documents). Country- and language-specific ICFs are provided (examples: Polish, Danish, German, Dutch, Italian, Hungarian, Spanish, Czech and English versions are listed). Specific ICFs for pregnant partners are available. Consent is provided by the participant (adults aged 18–70); no assent procedures for minors are provided.
Methods
- Online Outreach Text / digital adverts — country-specific online outreach materials are listed (e.g. 'K2_Recruitment material_Online Outreach Text_PL_Polish', 'K2_Recruitment material_Online Outreach Text_DE_German', 'K2_Recruitment Material_Online Outreach Text_ES_Spanish', 'K2_Recruitment material_Online Outreach Text_CZ_Czech', etc.), targeting potential participants with episodic migraine via online channels.
- Study Overview Flipchart — site-facing flipchart materials for presenting study overview to potential participants (country-specific versions: PL, DK, DE, NL, IT, HU, ES, CZ).
- Physician Fact Sheet / GP Letter — materials aimed at healthcare professionals to support referrals (examples: 'K2_Recruitment Material_Physician Fact Sheet_ES_Spanish', 'L1_GP Letter_IT_Italian').
- Site-based recruitment materials — Thank You cards, Patient ID cards and local recruitment handouts (examples present for CZ and other countries).
- K1 recruitment arrangements documents outlining recruitment and informed consent procedures (country-specific K1 files for DE, NL, IT, HU, CZ, PL, etc.).
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 477
Poland
- Earliest CTIS Part Ii Submission Date
- 21-10-2024
- Latest Decision Or Authorization Date
- 24-11-2024
- Processing Time Days
- 34
- Number Of Sites
- 10
- Number Of Participants
- 133
Sites
- Site Name
- Pratia S.A.
- Principal Investigator Name
- Jarosław Szczygiel
- Principal Investigator Email
- jwszczygiel@gmail.com
- Contact Person Name
- Jarosław Szczygiel
- Contact Person Email
- jwszczygiel@gmail.com
- Site Name
- Specjalistyczne Gabinety Sp. z o.o.
- Principal Investigator Name
- Lucyna Horodecka-Wardęga
- Principal Investigator Email
- lhwardega@specjalistycznegabinety.pl
- Contact Person Name
- Lucyna Horodecka-Wardęga
- Contact Person Email
- lhwardega@specjalistycznegabinety.pl
- Site Name
- Mtz Clinical Research Powered By Pratia
- Principal Investigator Name
- Krystyna Gospodarczyk-Szot
- Principal Investigator Email
- badacz@pratia.com
- Contact Person Name
- Krystyna Gospodarczyk-Szot
- Contact Person Email
- badacz@pratia.com
- Site Name
- Centrum Medyczne Hcp Sp. z o.o.
- Principal Investigator Name
- Przemysław Osip
- Principal Investigator Email
- przemyslaw.osip@cmhcp.pl
- Contact Person Name
- Przemysław Osip
- Contact Person Email
- przemyslaw.osip@cmhcp.pl
- Site Name
- Futuremeds Sp. z o.o.
- Principal Investigator Name
- Karolina Porębska
- Principal Investigator Email
- karolina.porebska@futuremeds.com
- Contact Person Name
- Karolina Porębska
- Contact Person Email
- karolina.porebska@futuremeds.com
- Site Name
- Pratia S.A.
- Principal Investigator Name
- Józef Kościelniak
- Principal Investigator Email
- jozef.koscielniak@pratia.pl
- Contact Person Name
- Józef Kościelniak
- Contact Person Email
- jozef.koscielniak@pratia.pl
- Site Name
- Etg Neuroscience Sp. z o.o.
- Principal Investigator Name
- Aleksandra Karbowniczek
- Principal Investigator Email
- a.karbowniczek@neuroscience.com.pl
- Contact Person Name
- Aleksandra Karbowniczek
- Contact Person Email
- a.karbowniczek@neuroscience.com.pl
- Site Name
- Solumed Sp. z o.o. sp.k.
- Principal Investigator Name
- Olgierd Stefański
- Principal Investigator Email
- olgierd_stefanski@interia.pl
- Contact Person Name
- Olgierd Stefański
- Contact Person Email
- olgierd_stefanski@interia.pl
- Site Name
- Futuremeds Sp. z o.o.
- Principal Investigator Name
- Bartosz Otak
- Principal Investigator Email
- bartosz.otak@futuremeds.com
- Contact Person Name
- Bartosz Otak
- Contact Person Email
- bartosz.otak@futuremeds.com
- Site Name
- Centrum Medyczne HOPE Clinic Sebastian Szklener
- Principal Investigator Name
- Sebastian Szklener
- Principal Investigator Email
- sebastianszklener@gmail.com
- Contact Person Name
- Sebastian Szklener
- Contact Person Email
- sebastianszklener@gmail.com
Denmark
- Earliest CTIS Part Ii Submission Date
- 08-11-2024
- Latest Decision Or Authorization Date
- 19-11-2024
- Processing Time Days
- 11
- Number Of Sites
- 1
- Number Of Participants
- 15
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Neurology
- Principal Investigator Name
- Messoud Ashina
- Principal Investigator Email
- messoud.ashina@regionh.dk
- Contact Person Name
- Messoud Ashina
- Contact Person Email
- messoud.ashina@regionh.dk
Germany
- Earliest CTIS Part Ii Submission Date
- 08-11-2024
- Latest Decision Or Authorization Date
- 22-11-2024
- Processing Time Days
- 14
- Number Of Sites
- 6
- Number Of Participants
- 61
Sites
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Bianca Raffaelli
- Principal Investigator Email
- bianca.raffaelli@charite.de
- Contact Person Name
- Bianca Raffaelli
- Contact Person Email
- bianca.raffaelli@charite.de
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Neurologie
- Principal Investigator Name
- Dagny Holle-Lee
- Principal Investigator Email
- dagny.holle-lee@uk-essen.de
- Contact Person Name
- Dagny Holle-Lee
- Contact Person Email
- dagny.holle-lee@uk-essen.de
- Site Name
- Technische Universitaet Dresden
- Department Name
- -
- Principal Investigator Name
- Gudrun Gossrau
- Principal Investigator Email
- gudrun.gossrau@ukdd.de
- Contact Person Name
- Gudrun Gossrau
- Contact Person Email
- gudrun.gossrau@ukdd.de
- Site Name
- Klinikum der Universitaet Muenchen AöR
- Department Name
- Neurologie Klinkum Grosshadern
- Principal Investigator Name
- Ruth Ruscheweyh
- Principal Investigator Email
- ruth.ruscheweyh@med.uni-muenchen.de
- Contact Person Name
- Ruth Ruscheweyh
- Contact Person Email
- ruth.ruscheweyh@med.uni-muenchen.de
- Site Name
- Kopfschmerzzentrum Frankfurt
- Department Name
- Interdisziplinäres Universitätsschmerzcentrum
- Principal Investigator Name
- Charly Gaul
- Principal Investigator Email
- c.gaul@kopfschmerz-frankfurt.de
- Contact Person Name
- Charly Gaul
- Contact Person Email
- c.gaul@kopfschmerz-frankfurt.de
- Site Name
- Pharmakologisches Studienzentrum Chemnitz GmbH
- Principal Investigator Name
- Ralf Bodenschatz
- Principal Investigator Email
- ralf.bodenschatz@studienzentrum-chemnitz.de
- Contact Person Name
- Ralf Bodenschatz
- Contact Person Email
- ralf.bodenschatz@studienzentrum-chemnitz.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 22-10-2024
- Latest Decision Or Authorization Date
- 21-11-2024
- Processing Time Days
- 30
- Number Of Sites
- 1
- Number Of Participants
- 59
Sites
- Site Name
- Leids Universitair Medisch Centrum (LUMC)
- Department Name
- Neurology
- Principal Investigator Name
- Gisela.M Terwindt
- Principal Investigator Email
- G.M.Terwindt@lumc.nl
- Contact Person Name
- Gisela.M Terwindt
- Contact Person Email
- G.M.Terwindt@lumc.nl
Italy
- Earliest CTIS Part Ii Submission Date
- 12-09-2024
- Latest Decision Or Authorization Date
- 21-11-2024
- Processing Time Days
- 70
- Number Of Sites
- 4
- Number Of Participants
- 62
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Dipartimento di Neurobiologia
- Principal Investigator Name
- Massimo Filippi
- Principal Investigator Email
- filippi.massimo@unisr.it
- Contact Person Name
- Massimo Filippi
- Contact Person Email
- filippi.massimo@unisr.it
- Site Name
- Universita' Campus Bio-medico Di Roma
- Department Name
- HEADACHE UNIT, NEUROLOGY UNIT
- Principal Investigator Name
- Fabrizio Vernieri
- Principal Investigator Email
- f.vernieri@unicampus.it
- Contact Person Name
- Fabrizio Vernieri
- Contact Person Email
- f.vernieri@unicampus.it
- Site Name
- Fondazione Istituto Neurologico Nazionale Casimiro Mondino
- Department Name
- U.O. Neuroriabilitazione
- Principal Investigator Name
- Cristina Tassorelli
- Principal Investigator Email
- cristina.tassorelli@mondino.it
- Contact Person Name
- Cristina Tassorelli
- Contact Person Email
- cristina.tassorelli@mondino.it
- Site Name
- Irccs San Raffaele Roma S.r.l.
- Department Name
- Dipartimento di Neurologia -Unità per la cura e la ricerca su cefalee e dolore
- Principal Investigator Name
- Piero Barbanti
- Principal Investigator Email
- piero.barbanti@sanraffaele.it
- Contact Person Name
- Piero Barbanti
- Contact Person Email
- piero.barbanti@sanraffaele.it
Hungary
- Earliest CTIS Part Ii Submission Date
- 01-10-2024
- Latest Decision Or Authorization Date
- 22-11-2024
- Processing Time Days
- 52
- Number Of Sites
- 3
- Number Of Participants
- 37
Sites
- Site Name
- Obudai Egeszseguegyi Centrum Kft.
- Principal Investigator Name
- Gyöngyi Szabó
- Principal Investigator Email
- gyongyi.szabo@oec.hu
- Contact Person Name
- Gyöngyi Szabó
- Contact Person Email
- gyongyi.szabo@oec.hu
- Site Name
- Obudai Egeszseguegyi Centrum Kft.
- Principal Investigator Name
- Lehel Finta
- Principal Investigator Email
- lehel.finta@oec.hu
- Contact Person Name
- Lehel Finta
- Contact Person Email
- lehel.finta@oec.hu
- Site Name
- S-Medicon Kft.
- Principal Investigator Name
- Mária Sátori
- Principal Investigator Email
- satori.maria@gmail.com
- Contact Person Name
- Mária Sátori
- Contact Person Email
- satori.maria@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 30-09-2024
- Latest Decision Or Authorization Date
- 21-11-2024
- Processing Time Days
- 52
- Number Of Sites
- 6
- Number Of Participants
- 50
Sites
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology
- Principal Investigator Name
- Patricia Pozo Rosich
- Principal Investigator Email
- patricia.pozo@vhir.org
- Contact Person Name
- Patricia Pozo Rosich
- Contact Person Email
- patricia.pozo@vhir.org
- Site Name
- Hospital Universitario La Paz
- Department Name
- Neurology
- Principal Investigator Name
- Javier Diaz de Teran Velasco
- Principal Investigator Email
- javierddt@gmail.com
- Contact Person Name
- Javier Diaz de Teran Velasco
- Contact Person Email
- javierddt@gmail.com
- Site Name
- Hospital Universitario De Badajoz
- Department Name
- Neurology
- Principal Investigator Name
- José Maria Ramirez-Moreno
- Principal Investigator Email
- josemaria.ramirez@salud-juntaex.es
- Contact Person Name
- José Maria Ramirez-Moreno
- Contact Person Email
- josemaria.ramirez@salud-juntaex.es
- Site Name
- Hospital Del Mar
- Department Name
- Neurology
- Principal Investigator Name
- Elisa Cuadrado Godia
- Principal Investigator Email
- ecuadrado@psmar.cat
- Contact Person Name
- Elisa Cuadrado Godia
- Contact Person Email
- ecuadrado@psmar.cat
- Site Name
- Hospital Clinico Universitario De Valencia
- Department Name
- Neurology
- Principal Investigator Name
- Maria Eugenia Bosca Blasco
- Principal Investigator Email
- maria.boscablasco@uchceu.es
- Contact Person Name
- Maria Eugenia Bosca Blasco
- Contact Person Email
- maria.boscablasco@uchceu.es
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Neurology
- Principal Investigator Name
- Samuel Díaz Insa
- Principal Investigator Email
- sdiazinsa@yahoo.es
- Contact Person Name
- Samuel Díaz Insa
- Contact Person Email
- sdiazinsa@yahoo.es
Czechia
- Earliest CTIS Part Ii Submission Date
- 26-08-2024
- Latest Decision Or Authorization Date
- 20-11-2024
- Processing Time Days
- 86
- Number Of Sites
- 9
- Number Of Participants
- 60
Sites
- Site Name
- Axon Clinical s.r.o.
- Department Name
- Neurology
- Principal Investigator Name
- Zuzana Matousova
- Principal Investigator Email
- zuzana.matousova@axon-clinical.com
- Contact Person Name
- Zuzana Matousova
- Contact Person Email
- zuzana.matousova@axon-clinical.com
- Site Name
- Brain-Soultherapy s.r.o.
- Department Name
- neurologicko-psychiatrická ambulance
- Principal Investigator Name
- Klaudia Vodickova-Borzova
- Principal Investigator Email
- cborzova@seznam.cz
- Contact Person Name
- Klaudia Vodickova-Borzova
- Contact Person Email
- cborzova@seznam.cz
- Site Name
- Institut Neuropsychiatricke Pece (INEP)
- Department Name
- Neurology x
- Principal Investigator Name
- Tomas Nezadal
- Principal Investigator Email
- nezadal@inep.cz
- Contact Person Name
- Tomas Nezadal
- Contact Person Email
- nezadal@inep.cz
- Site Name
- Vestra Clinics s.r.o.
- Department Name
- neurology
- Principal Investigator Name
- Ladislav Pazdera
- Principal Investigator Email
- pazdera@vestraclinics.org
- Contact Person Name
- Ladislav Pazdera
- Contact Person Email
- pazdera@vestraclinics.org
- Site Name
- Praglandia s.r.o.
- Department Name
- Neurology
- Principal Investigator Name
- Luisa Bartlova
- Principal Investigator Email
- l.bartl@praglandia.cz
- Contact Person Name
- Luisa Bartlova
- Contact Person Email
- l.bartl@praglandia.cz
- Site Name
- Clintrial s.r.o.
- Department Name
- Neurology
- Principal Investigator Name
- Miroslava Chylova
- Principal Investigator Email
- m.chylova@clintrial.cz
- Contact Person Name
- Miroslava Chylova
- Contact Person Email
- m.chylova@clintrial.cz
- Site Name
- Dado Medical s.r.o.
- Department Name
- Neurology
- Principal Investigator Name
- David Dolezil
- Principal Investigator Email
- research@dadomedical.cz
- Contact Person Name
- David Dolezil
- Contact Person Email
- research@dadomedical.cz
- Site Name
- Forbeli s.r.o.
- Department Name
- Neurology
- Principal Investigator Name
- Michal Bajacek
- Principal Investigator Email
- mbajacek@yahoo.co.uk
- Contact Person Name
- Michal Bajacek
- Contact Person Email
- mbajacek@yahoo.co.uk
- Site Name
- Praglandia s.r.o. (additional site)
- Department Name
- Neurology
- Principal Investigator Name
- Luisa Bartlova
- Principal Investigator Email
- l.bartl@praglandia.cz
- Contact Person Name
- Luisa Bartlova
- Contact Person Email
- l.bartl@praglandia.cz
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Fortrea Inc.
- Responsibilities
- Multiple sponsor duties (codes: 1,12,2,5,8) as listed in CTIS third party entries
- Name
- Perceptive Eclinical Limited
- Responsibilities
- Sponsor duties (code: 3) — eClinical services
- Name
- Drug Development Solutions Limited
- Responsibilities
- PK Lab
Third parties
- {"country":"United Kingdom","full_name":"Drug Development Solutions Limited","duties_or_roles":"PK Lab","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties code: 4","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"sponsorDuties code: 3","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"sponsorDuties codes: 1, 12, 2, 5, 8","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Central ECG reader","organisation_type":"Industry"}
- {"country":"Germany","full_name":"BioAgilytix Europe GmbH","duties_or_roles":"ADA Lab","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- MEDI0618
- Active Substance
- MEDI0618
- Modality
- Peptide/protein/enzyme
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- Subcutaneous injection
- Investigational Product Name
- Placebo to match MEDI0618
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