A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period on Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study With an Open-Label Treatment Period of Fremanezumab Administered Subcutaneously Monthly or Quarterly for the Preventive Treatment of Migraine in Adult Chinese Patients

Primary Objective:

To demonstrate the efficacy of fremanezumab administered as monthly and quarterly subcutaneous (sc) injections to adult Chinese participants with migraine.

Secondary Objectives:

• To further demonstrate the efficacy of fremanezumab administered as monthly and quarterly sc injections.
• To evaluate the safety and tolerability of fremanezumab administered as monthly and quarterly sc injections.

The total study duration for participants is planned to be approximately 9 months. The study will consist of a screening visit, a baseline period (4 weeks), a 12-week double-blind treatment period, a 12-week open-label treatment period, and a follow-up period lasting approximately 3 months after the last dose of treatment.

Inclusion Criteria:

• The participant has a diagnosis of migraine with onset at ≤50 years of age.
• The participant has a body weight ≥45 kg and body mass index within the range 17.5 to 34.9 kg/m2 (inclusive).
• The participant has a history of migraine for ≥12 months prior to screening.
• Women of childbearing potential (WOCBP) whose male partners are potentially fertile (that is; no vasectomy) must use highly effective birth control methods for the duration of the study and for 6.0 months after discontinuation of investigational medicinal product (IMP).
• Men must be sterile or, if they are potentially fertile/reproductively competent (not congenitally sterile) and their female partners are of childbearing potential, should use highly effective birth control for the duration of the study.
• Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

• Use of medications containing opioids (including codeine), barbiturates (including butalbital), or any combination product containing opioids or barbiturates (including butalbital) on more than 4 days during the screening period for the treatment of migraine or for any other reason.
• Has used an intervention/device (eg, scheduled nerve blocks or transcranial magnetic stimulation) for migraine, or in the head or neck area, during the 2 months prior to screening (visit 1).
• History of clinically significant cardiovascular disease or vascular ischemia (such as myocardial, neurological [eg, cerebral ischemia], or peripheral extremity ischemia or other ischemic event) or thromboembolic events (arterial or venous thrombotic or embolic events), such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis, or pulmonary embolism.
• History of human immunodeficiency virus, tuberculosis, Lyme disease, or a known or suspected active infection of coronavirus disease 2019 (COVID-19).
• Known current infection or history of infection in the past 6 months with hepatitis B or C viruses.
• History of cancer in the past 5 years, except for appropriately treated non-melanoma skin carcinoma.
• History of hypersensitivity reactions to injected proteins, including monoclonal antibodies (mAbs), or a history of Stevens-Johnson Syndrome or toxic epidermal necrolysis syndrome, or is concomitantly using lamotrigine.
• Any clinically significant uncontrolled medical condition (treated or untreated).
• History of alcohol or drug abuse during the past 2 years or drug dependence during the past 5 years.
• Additional criteria apply, please contact the investigator for more information.