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IRCT20150303021315N41 IRCT 2026-03-08 Cinnagen company Non-inferiority evaluation of Galcanezumab (CinnaGen) VS. Emgality ® (Galcanezumab produced by Eli Lilly Co.) A phase III, randomized, two-armed, double-blind, single-center, parallel, active-controlled, non-inferiority clinical trial to compare efficacy and safety of Galcanezumab (CinnaGen Co.) versus Emgality® (Eli Lilly Co.) in adults with treatment-resistant migraine 2026-02-21 anticipated 226 Recruiting https://irct.ir/trial/88859 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients will be conducted using R-CRAN software version 4.4.0, utilizing block randomization (with sizes of 2 and 4) stratified by the type of migraine (chronic/episodic), receiving concomitant prophylactic medication (yes/no) and number of previous failure to migraine preventive medication categories (two / more than two) for a total of 226 patients (with a 1:1 ratio). The randomization process will be performed centrally, meaning that each patient will be allocated to one of these strata upon entering the study based on their conditions. Then, by contacting the unit responsible for randomization, they will be assigned to a treatment group using the random list corresponding to that stratum. Once randomization is completed, each patient will be assigned a code that will identify them throughout the study. The assigned code will consist of four letters (the first two letters of the first name and the first two letters of the last name), three numbers (the center code), three letters representing the generic drug name (which is GLC), and three digits (corresponding to the randomization code), forming the patient code. For example: ABCD001GLC-001. The randomization numbers will be assigned sequentially, Blinding description: Due to the identical appearance of the syringes in both products, the information about the type of drug is indistinguishable for patients and healthcare professionals. The same research label will be designed for both study drugs. The content of the labels is based on EMA regulation. The therapeutic drug galcanezumab (CinnaGen Research and Manufacturing Company) compared to Emgality® (galcanezumab manufactured by Eli Lilly) are relabelled and packaged completely identically before the study begins. Blinding codes will be included on the drug label and each drug will be linked to a patient through this unique code, ensuring that the patient, healthcare staff, and other personnel remain unaware of the drug type. The randomization of patients and their treatment arm will not be disclosed to the study administrators and the relevant information for each patient will be provided to the investigator at the center in sealed opaque envelopes. Furthermore, individuals reviewing results and analyzing data will not be aware of the patient group classifications. A nurse will be assigned at the center for this study, responsible for administering the medication throughout the entire study duration. For the nurse injecting the drug, due to the similarity of the pharmaceutical form, according to the developed executive process, the drug is injected exclusively by the nurse and it is not possible to identify the drug type. The route of administration of the drug is subcutaneous and is done through the identical syringes. After ensuring the patient's eligibility and signing the informed consent form, according to the randomization list, patients are placed in a specific treatment group and the randomization code is announced to the nurse responsible for injecting the drug via telephone call. Decoding or breaking the blinding of the entire study based on grouping is under special conditions and is the responsibility of the DSMB committee. A request for decoding for a specific patient by the center's researcher is made when all possible cases of a specific event have been examined and, by ruling out all cases, the type of brand of drug used is identified as the most important factor in the occurrence of an event or the management of its complications, and knowing the brand name leads to specific treatment for that patient and making a decision that is not possible without decoding. 3 treatment-resistant migraine. Intervention 1: Group 1: Galcanezumab (CinnaGen Co.), Galcanezumab 240 mg (2 PFSs of 120 mg/ml) at day 0 and 120 mg (one PFS) at days 30 and 60 administered by subcutaneous injection. Intervention 2: Group 2: Emgality® (Galcanezumab produced by Eli Lilly Co.), Galcanezumab 240 mg (2 PFSs of 120 mg/ml) at day 0 and 120 mg (one PFS) at days 30 and 60 administered by subcutaneous injection. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Dr. Hamidreza Kafi
No 42, Attar St., Vanak Sq
Tehran Iran (Islamic Republic of) 1994766411 +98 21 4347 3000 Kafi.H@orchidpharmed.com Orchid Pharmed Co. scientific Dr. Mansoureh Togha
Imam Khomeini Street, next to Hasan Abad square, Imam Khomeini Street, Sina Hospital
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6634 8500 toghae@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients are 18 to 60 years of age (inclusive) at the time of signing the informed consent form Have a diagnosis of migraine as defined by International Headache Society (IHS) International Classification of Headache Disorders (ICHD-3 2018) (migraine with or without aura), with a history of migraine of at least 1 year prior to screening, and migraine onset prior to age 50 Prior to screening, have a history of at least 4 migraine headache days and at least 1 headache-free day per month on average within the past 3 months Prior to screening, have previous failure to 2 to 4 migraine preventive medication categories in the past 10 years from the following list: a) propranolol or metoprolol, b) topiramate, c) valproate or divalproex, d) amitriptyline or nortriptyline, e) venlafaxine or duloxetine, f) flunarizine, g) botulinum toxin A or B During prospective baseline period, have a frequency of 4 or more migraine headache days and at least 1 headache-free day in the 30-day run-in period Ability to comprehend and willingness to sign the informed consent form for this study and adherence to the study protocol principles 18 years 60 years Both Treatment with any investigational agent in the last 30 days prior to screening visit or passing less than five half-lives of the investigational agent (whichever is longer) or participating in clinical studies consisting of any investigational agent or procedure Prior exposure to Galcanezumab or another CGRP (Calcitonin gene-related peptide) antibody Have a history of known serious allergies to any components of the formulation Receiving more than one medication or other treatments for the prevention of migraine in the run-in visit. Patients must have discontinued such treatment(s) at least 30 days prior to entering the run-in period. Botulinum toxin A and B that has been administered in the head or neck area for therapeutic use must be discontinued at least 3 months prior to entering the run-in period. Failure to respond to more than 4 migraine preventive medication categories from the list in Inclusion Criterion [4]. Previous failures to medications not on the above list will not count toward this exclusion. History of other types of headaches besides migraine, tension type headache, or medication overuse headache (MOH) as defined by IHS ICHD-3 in the 3 months prior to randomization (In other words, patients can have migraine, tension type headache, or MOH in the 3 months prior to randomization, but they cannot have other types of headaches in that time.) History of cluster headache or migraine subtypes including hemiplegic (sporadic or familial) migraine, ophthalmoplegic migraine, and migraine with brainstem aura (basilar-type migraine) defined by IHS ICHD-3 History of head or neck injury within 6 months prior to screening History of traumatic head injury associated with a significant change in the quality or frequency of headaches History of myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft, deep vein thrombosis/pulmonary embolism, or stroke within 6 months of screening, or have planned cardiovascular surgery or percutaneous coronary intervention Patients who have used opioids or barbiturate >4 days per month for the treatment of pain in more than 2 of the past 3 months Alanine aminotransferase (ALT) >3-fold upper limit of normal (ULN), or total bilirubin (TBL) >2-fold ULN, or alkaline phosphatase (ALP) >3-fold ULN at the screening visit History of significant psychiatric disease, such as bipolar disorder, schizophrenia, personality disorders, or other serious mood or anxiety disorders. Note: Patients with major depressive disorder (MDD) or generalized anxiety disorder (GAD) whose disease state is considered stable and expected to remain stable throughout the course of the study, in the opinion of the investigator, may be considered for inclusion if they are not on excluded medications. Women who are pregnant, nursing, or planning a pregnancy during the study History of drug or alcohol abuse/dependence within 1 year prior to screening judged by the investigator Having any other condition such as major neurologic diseases which, in the opinion of the investigator, will make the subject inappropriate for enrolling the study G43.9 Migraine, unspecified Treatment - Drugs Treatment - Drugs Group 1: Galcanezumab (CinnaGen Co.), Galcanezumab 240 mg (2 PFSs of 120 mg/ml) at day 0 and 120 mg (one PFS) at days 30 and 60 administered by subcutaneous injection Group 2: Emgality® (Galcanezumab produced by Eli Lilly Co.), Galcanezumab 240 mg (2 PFSs of 120 mg/ml) at day 0 and 120 mg (one PFS) at days 30 and 60 administered by subcutaneous injection The overall proportion of patients with ≥50% reduction from run-in in monthly Migraine Headache days (MHDs) during the 3-month study period. Timepoint: Beginning of study, 90 days after intervention. Method of measurement: Assessment based on electronic Patient Reported Outcome (ePRO) questionnaire. The overall mean change from run-in in the number of monthly Migraine Headache Days (MHDs) during the 3-month study period. Timepoint: Beginning of the study, 90 days after intervention. Method of measurement: Assessment based on electronic Patient Reported Outcome (ePRO) questionnaire. The overall mean change from run-in in the number of monthly MHDs leading to taking medication for the acute treatment of headache during the 3-month study period. Timepoint: Beginning of the study, during 90 days after intervention. Method of measurement: Assessment based on ePRO questionnaire. The overall mean change from run-in in the number of monthly headache days during the 3-month study period. Timepoint: Beginning of the study, during 90 days after intervention. Method of measurement: Assessment based on ePRO questionnaire. The proportion of patients who maintain 50% response criteria for all 3 months of study period. Timepoint: Beginning of the study, during 90 days after intervention. Method of measurement: Assessment based on ePRO questionnaire. Overall mean change from run-in in the migraine attacks monthly measures (during the 3-month study period) in patients with episodic migraine. Timepoint: Beginning of the study, during 90 days after intervention. Method of measurement: Assessment based on ePRO questionnaire. The overall mean change from run-in in the number of monthly moderate to severe headache days during the 3-month study period. Timepoint: Beginning of the study, during 90 days after intervention. Method of measurement: Assessment based on ePRO questionnaire. Change from run-in in the number of monthly MHDs with: •Nausea and/or vomiting •Photophobia and/or phonophobia. Timepoint: Beginning of the study, during 90 days after intervention. Method of measurement: Assessment based on ePRO questionnaire. Assessment of adverse events. Timepoint: During all scheduled visits. Method of measurement: Clinical monitoring. Assessment of immunogenicity (Assessment of anti-drug antibody (ADA) development in patients). Timepoint: Screening, Day 90. Method of measurement: Affinity capture elusion Enzyme-linked immunosorbent assay (ELISA) technique. Cinnagen company Approved 2026-02-16 Research Ethics Committees of Neuroscience Institute Neuroscience Institute, Imam Khomeini Hospital, The end of Keshavarz Boulevard, Tehran Tehran Tehran Iran (Islamic Republic of)