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Completed

NCT Number: NCT05458011

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

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.

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Key information

Conditions

Migraine Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Migraine Disorders Nervous System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Teva Investigational Site 88028, Baotou Shi, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fremanezumab

Drug

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Other names: TEV-48125, Ajovy

Placebo

Drug

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Primary outcomes

  1. Double Blind (DB) Period: Mean Change From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab

    Time frame: Baseline (Day -28 to Day -1), up to Week 12

    A migraine day was defined as a calendar day where the participant reported either of the following: A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for migraine with or without aura or; a calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) * 28. Least square (LS) mean was calculated using analysis of covariance (ANCOVA).

Secondary outcomes

  1. DB Period: Mean Change From Baseline in the Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab

    Time frame: Baseline (Day -28 to Day -1), Up to Week 4

    A migraine day was defined as a calendar day where the participant reported either of the following: A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for migraine with or without aura or; a calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 4-week period/number of days with assessments recorded in e-diary for 4-week period) * 28.

  2. DB Period: Mean Change From Baseline in the Monthly Average Number of Days of Use of Any Acute Headache Medications During the 12-Week Period After the First Dose of Fremanezumab

    Time frame: Baseline (Day -28 to Day -1), Up to Week 12

    Participants recorded any headache medications (name of drug, number of tablets/capsules, and the dose in milligrams per tablet/capsule) taken each day in their electronic headache diary device. Acute headache medication included opioids, barbiturates, triptans, ergots, non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen and their combination products. Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) * 28.

  3. DB Period: Number of Participants Reaching at Least 50% Reduction From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab

    Time frame: Baseline (Day -28 to Day-1), Up to Week 12

    A migraine day was defined as a calendar day where the participant reported either of the following: A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for migraine with or without aura or; a calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of a headache meeting the criteria for probable migraine, a migraine subtype where only 1 migraine criterion is missing; a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine specific medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) * 28.

  4. DB Period: Mean Change From Baseline in the Monthly Average Number of Headache Days of at Least Moderate Severity During the 12-Week Period After the First Dose of Fremanezumab

    Time frame: Baseline (Day -28 to Day -1), Up to Week 12

    A headache day of at least moderate severity was defined as a calendar day (00:00 to 23:59) where the participant reported either of the following: A calendar day (0:00 to 23:59) demonstrating at least 2 consecutive hours of headache of at least moderate severity; or a calendar day (0:00 to 23:59) demonstrating a headache of any duration that was treated with migraine-specific acute medications (triptans and ergot compounds). Monthly averages were derived and normalized to 28 days equivalent by formula: (number of days of efficacy variable over 12-week period/number of days with assessments recorded in e-diary for 12-week period) * 28.

  5. DB Period: Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)

    Time frame: Week 0 up to Week 12

    An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious AEs (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  6. DB Period: Number of Participants Who Did Not Complete the Study Due to AEs

    Time frame: Week 0 up to Week 12

    An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  7. OL Period: Number of Participants With at Least One TEAE

    Time frame: Week 12 up to Week 24

    An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  8. OL Period: Number of Participants Who Did Not Complete the Study Due to AEs

    Time frame: Week 12 up to Week 24

    An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs were defined as AEs that occurred after the first dose of study drug was administered through end of the trial. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  9. DB Period: Number of Participants Who Received Concomitant Medications for AEs

    Time frame: Week 0 up to Week 12

    Concomitant medications included all medications taken while the participant was treated with the study drug. Any concomitant medication received by the participant for AEs was recorded on the case report form (CRF). Concomitant medications included: butalbital for migraine/headache, ergots for migraine/headache, NSAIDs for migraine/headache, NSAIDs for other reason than migraine/headache, opioids for migraine/headache, opioids for reasons other reason than migraine/headache, preventive medication as specified in the protocol for migraine/headache, preventive medication as specified in the protocol for other reason than migraine/headache, triptans for migraine/headache.

  10. OL Period: Number of Participants Who Received Concomitant Medications for AEs

    Time frame: Week 12 up to Week 24

    Concomitant medications included all medications taken while the participant was treated with the study drug. Any concomitant medication received by the participant for AEs was recorded on the case report form (CRF). Concomitant medications included: butalbital for migraine/headache, ergots for migraine/headache, NSAIDs for migraine/headache, NSAIDs for other reason than migraine/headache, opioids for migraine/headache, opioids for reasons other reason than migraine/headache, preventive medication as specified in the protocol for migraine/headache, preventive medication as specified in the protocol for other reason than migraine/headache, triptans for migraine/headache.

  11. Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADA)

    Time frame: Day 1 up to Day 225

  12. Number of Participants With Treatment-Emergent Neutralizing Antibodies (NAbs)

    Time frame: Day 1 up to Day 225

Sponsors and collaborators

Lead sponsor

Teva Branded Pharmaceutical Products R&D, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 14, 2022
Registry last updated
Nov 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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