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    Summary
    EudraCT Number:2017-004351-23
    Sponsor's Protocol Code Number:I5Q-MC-CGAS
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-05-24
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-004351-23
    A.3Full title of the trial
    A Randomized, Double-Blind, Placebo-Controlled Study of Galcanezumab in Patients 6 to 17 Years of Age with Episodic Migraine – the REBUILD-1 Study
    Uno studio randomizzato, in doppio cieco, controllato verso placebo con Galcanezumab in pazienti di età compresa tra 6 e 17 anni con emicrania episodica – Studio REBUILD-1
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Galcanezumab in Patients 6 to 17 Years of Age With Episodic Migraine (REBUILD-1)
    Uno studio con Galcanezumab in pazienti di età compresa tra 6 e 17 anni con emicrania episodica – (Studio REBUILD-1)
    A.3.2Name or abbreviated title of the trial where available
    REBUILD-1
    na
    A.4.1Sponsor's protocol code numberI5Q-MC-CGAS
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/136/2020
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorELI LILLY & COMPANY, LILLY CORPORATE CENTER
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.1.1Trade name Emgality
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGalcanezumab
    D.3.2Product code [LY2951742]
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGALCANEZUMAB
    D.3.9.1CAS number 1578199-75-3
    D.3.9.2Current sponsor codeLY2951742
    D.3.9.4EV Substance CodeSUB183792
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Episodic Migraine
    Emicrania Episodica
    E.1.1.1Medical condition in easily understood language
    Migraine headache
    Emicrania
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10027602
    E.1.2Term Migraine headache
    E.1.2System Organ Class 100000004852
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the superiority of galcanezumab versus placebo in the prevention of migraine in (at least) 1 of the following populations with migraine: the overall pediatric population (6 to 17 year-olds) or the adolescent population (12 to 17 year-olds).
    Dimostrare la superiorità di galcanezumab rispetto al placebo nella prevenzione dell’emicrania in (almeno) 1 delle seguenti popolazioni con emicrania: la popolazione pediatrica complessiva (6-17 anni) o la popolazione adolescente (12-17 anni).
    E.2.2Secondary objectives of the trial
    to evaluate the efficacy and safety of galcanezumab
    valutare la sicurezza e efficacia di galcanezumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Have a diagnosis of migraine with or without aura as defined by the IHS ICHD-3 guidelines (1.1 or 1.2 according to ICHD-3 [2018]), with a history of migraine headaches of at least 6 months prior to screening.
    • Diagnosi di emicrania con o senza aura secondo la definizione delle linee guida ICHD-3 dell’IHS (1.1 o 1.2 secondo l’ICHD-3 [2018]), con anamnesi di cefalea emicranica risalente ad almeno 6 mesi prima dello screening.
    E.4Principal exclusion criteria
    • Participants who are taking, or are expected to take, therapeutic antibodies during the course of the study (adalimumab, infliximab, trastuzumab, bevacizumab, etc.). Prior use of therapeutic antibodies, other than antibodies to calcitonin gene-related peptide (CGRP) or its receptor, is allowed if that use was more than 12 months prior to baseline.
    • Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic proteins, or to galcanezumab or its excipients.
    • Current use or prior exposure to galcanezumab, another CGRP antibody, or CGRP receptor antibody, including those who have previously completed or withdrawn from this study or any other study investigating a CGRP antibody.
    • History of persistent daily headache, cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine and migraine with brainstem aura (previously basilar-type migraine) as defined by IHS ICHD-3.
    • History of significant head or neck injury within 6 months prior to screening; or traumatic head injury at any time that is associated with significant change in the quality or frequency of their headaches, including new onset of migraine following traumatic head injury.
    • Participants with a known history of intracranial tumors or developmental malformations including Chiari malformations.
    • Partecipanti che assumono, o potrebbero assumere, anticorpi terapeutici nel corso dello studio (adalimumab, infliximab, trastuzumab, bevacizumab ecc.). L’uso pregresso di anticorpi terapeutici, diversi dagli anticorpi diretti contro il peptide correlato al gene della calcitonina (CGRP) o il relativo recettore, è consentito se avvenuto a più di 12 mesi dal basale.
    • Ipersensibilità nota a più farmaci, anticorpi monoclonali o altre proteine terapeutiche, a galcanezumab o ai relativi eccipienti.
    • Uso attuale o precedente esposizione a galcanezumab, un altro anticorpo diretto contro il CGRP o il relativo recettore, compresi i soggetti che hanno completato o si sono ritirati dal presente studio o da qualsiasi altro studio su anticorpi anti-CGRP.
    • Anamnesi di cefalea giornaliera persistente, cefalea a grappolo o sottotipi di emicrania tra cui emicrania emiplegica (sporadica o familiare) ed emicrania con aura del tronco encefalico (emicrania di tipo basilare) definite dai criteri ICHD-3 dell’IHS.
    • Anamnesi di importante lesione cranica o cervicale nei 6 mesi precedenti lo screening; o trauma cranico, subito in un qualsiasi momento, che sia associato a variazioni significative della qualità o della frequenza delle cefalee, compresa la nuova insorgenza di emicrania dopo il trauma cranico.
    • Partecipanti con anamnesi nota di tumori intracranici o malformazioni dello sviluppo, comprese le malformazioni di Chiari.
    E.5 End points
    E.5.1Primary end point(s)
    1. Change from Baseline in the Number of Monthly Migraine Headache Days
    1. Variazione rispetto al basale del numero di giorni di cefalea emicranica al mese
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Time Frame: Baseline, 3 Months
    1. Time Frame: Baseline, 3 Mesi
    E.5.2Secondary end point(s)
    2. Percentage of Participants with Reduction from Baseline =50%, =75% and 100% in Monthly Migraine Headache Days
    3. Change from Baseline in the Number of Monthly Migraine Headache Days with Nausea and/or Vomiting
    4. Change from Baseline in the Number of Monthly Migraine Headache Days with Photophobia and Phonophobia
    5. Change from Baseline in the Number of Monthly Migraine Headaches with Prodromal Symptoms
    6. Change from Baseline in the Number of Migraine Headache Days on which Acute Headache Medication is Taken
    7. Patient Global Impression-Improvement (PGI-I) Rating
    8. Change from Baseline in the Severity of Remaining Migraine Headaches per Month
    9. Change from Baseline in the Number of Monthly Headache Days
    10. Change from Baseline on the Pediatric Quality of Life Inventory (PedsQL) Total Score
    11. Change from Baseline on the Pediatric Migraine Disability Assessment Test (PedMIDAS) Total Score
    12. Percentage of Participants with Suicidal Ideation and Behaviors Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS) Score
    13. Pharmacokinetics (PK): Serum Concentration of Galcanezumab
    14. Plasma Concentration of Calcitonin Gene-Related Peptide (CGRP)
    15. Percentage of Participants Developing Anti-Drug Antibodies
    16. Percentage of Participants who Initiate Migraine Prevention Medication in the Post-Treatment Follow-Up Phase
    2. Percentuale di partecipanti con una riduzione rispetto al basale =50%, =75% e 100% dei giorni di emicrania al mese
    3. Variazione rispetto al basale del numero di giorni di cefalea emicranica al mese con nausea e/o vomito
    4. Variazione rispetto al basale del numero di giorni di cefalea emicranica al mese con fotofobia e fonofobia
    5. Variazione rispetto al basale del numero di giorni di cefalea emicranica al mese, con sintomi prodromici
    6. Variazione rispetto al basale del numero di giorni di cefalea emicranica con utilizzo di medicinali per il trattamento in acuto della cefalea
    7. Valutazione secondo il questionario PGI-I (Patient Global Impression-Improvement)
    8. Variazione rispetto al basale della gravità delle cefalee emicraniche rimanenti al mese
    9. Variazione rispetto al basale del numero di giorni di cefalea al mese
    10. Variazione rispetto al basale del punteggio totale al questionario PedsQL (Pediatric Quality of Life Inventory)
    11. Variazione rispetto al basale del punteggio totale al questionario PedMIDAS (Pediatric Migraine Disability Assessment Test)
    12. Percentuale di partecipanti con ideazioni e comportamenti suicidari valutati secondo il punteggio alla Scala della Columbia University per la valutazione della gravità del rischio di suicidio (C-SSRS)
    13. Farmacocinetica (PK): concentrazioni sieriche di galcanezumab
    14. Concentrazioni plasmatiche del peptide correlato al gene della calcitonina (CGRP)
    15. Percentuale di partecipanti che sviluppano anticorpi anti-farmaco
    16. Percentuale di partecipanti che iniziano ad assumere farmaci per la prevenzione dell’emicrania nella fase di follow-up post-trattamento
    E.5.2.1Timepoint(s) of evaluation of this end point
    2. Time Frame: 3 Months
    3. Time Frame: Baseline, 3 Months
    4. Time Frame: Baseline, 3 Months
    5. Time Frame: Baseline, 3 Months
    6. Time Frame: Baseline, 3 Months
    7. Time Frame: Month 1 to Month 3
    8. Time Frame: Baseline, 3 Months
    9. Time Frame: Baseline, 3 Months
    10. Time Frame: Baseline, 3 Months
    11. Time Frame: Baseline, 3 Months
    12. Time Frame: Baseline through 3 Months
    13. Time Frame: Baseline through 3 Months
    14. Time Frame: Baseline through 3 Months
    15. Time Frame: Baseline through 3 Months
    16. Time Frame: 16 Months
    2. Time Frame: 3 Months
    3. Time Frame: Baseline, 3 Months
    4. Time Frame: Baseline, 3 Months
    5. Time Frame: Baseline, 3 Months
    6. Time Frame: Baseline, 3 Months
    7. Time Frame: Month 1 to Month 3
    8. Time Frame: Baseline, 3 Months
    9. Time Frame: Baseline, 3 Months
    10. Time Frame: Baseline, 3 Months
    11. Time Frame: Baseline, 3 Months
    12. Time Frame: Baseline through 3 Months
    13. Time Frame: Baseline through 3 Months
    14. Time Frame: Baseline through 3 Months
    15. Time Frame: Baseline through 3 Months
    16. Time Frame: 16 Months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    India
    Japan
    Mexico
    United States
    Denmark
    Germany
    Italy
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of the trial is the date of the last visit or last scheduled procedure
    La fine dello studio è la data dell'ultima visita o dell'ultima procedura programmata
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days15
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) Yes
    F.1.1.5.1Number of subjects for this age range: 60
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 240
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Subjects under age of majority must have informed consent provided by parent or legal guardian
    I soggetti di età inferiore alla maggiore età devono avere il consenso informato fornito dal genitore o tutore legale
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 64
    F.4.2.2In the whole clinical trial 300
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None.
    nessuno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-01-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-21
    P. End of Trial
    P.End of Trial StatusOngoing
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