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.

Study Overview

• Status: Active, not recruiting
• Conditions: Migraine
• Intervention / Treatment: Drug: Fremanezumab; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 365
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Teva U.S. Medical Information; Phone Number: 1-888-483-8279; Email: USMedInfo@tevapharm.com

Study Locations

• China
  • Baotou Shi, China, 014060
    • Teva Investigational Site 88028
  • Beijing, China, 100853
    • Teva Investigational Site 88001
  • Beijing Shi, China, 100044
    • Teva Investigational Site 88004
  • Changchun, China, 130021
    • Teva Investigational Site 88008
  • Changchun, China, 130041
    • Teva Investigational Site 88009
  • Changsha Shi, China, 410008
    • Teva Investigational Site 88022
  • Changsha Shi, China, 410013
    • Teva Investigational Site 88030
  • Chengdu Shi, China, 610041
    • Teva Investigational Site 88003
  • Chongqing, China, 400700
    • Teva Investigational Site 88029
  • Fuzhou, China, 350001
    • Teva Investigational Site 88019
  • Guangzhou Shi, China, 510260
    • Teva Investigational Site 88020
  • Guiyang, China, 550004
    • Teva Investigational Site 88013
  • Harbin Shi, China, 150001
    • Teva Investigational Site 88026
  • Lianyungang, China, 222002
    • Teva Investigational Site 88010
  • Luoyang, China, 4710039
    • Teva Investigational Site 88005
  • Rizhao, China, 276800
    • Teva Investigational Site 88033
  • Shanghaishi, China, 200040
    • Teva Investigational Site 88021
  • Shanghaishi, China, 200120
    • Teva Investigational Site 88025
  • Shenyang Shi, China, 110016
    • Teva Investigational Site 88016
  • Shijiazhuang Shi, China, 50073
    • Teva Investigational Site 88011
  • Suzhou Shi, China, 215004
    • Teva Investigational Site 88015
  • Tianjin Shi, China, 300052
    • Teva Investigational Site 88024
  • Tianjin Shi, China, 300120
    • Teva Investigational Site 88023
  • Wenzhou, China, 325000
    • Teva Investigational Site 88017
  • Wuhan Shi, China, 430030
    • Teva Investigational Site 88012
  • Wuhan Shi, China, 430071
    • Teva Investigational Site 88006
  • Xining Shi, China, 810007
    • Teva Investigational Site 88032
  • Zhanjiang, China, 524008
    • Teva Investigational Site 88031
  • Zhengzhou Shi, China, 450003
    • Teva Investigational Site 88034

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fremanezumab Monthly; Double Blind (DB) Period: Participants will receive fremanezumab once a month (approximately every 4 weeks). Participants will receive a single injection of fremanezumab and two placebo injections on Day 1, and a single injection of fremanezumab on Days 29 and 57. Open Label (OL) Period: Participants will receive fremanezumab once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.	Drug: Fremanezumab; Pharmaceutical form: solution for injection Route of administration: subcutaneous injection; Other Names: TEV-48125; Ajovy; Drug: Placebo; Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
Experimental: Fremanezumab Quarterly; DB Period: Participants will receive fremanezumab once a quarter (once at the beginning of the 12-week double-blind treatment period). Participants will receive 3 injections of fremanezumab on Day 1, and a single placebo injection on Days 29 and 57. OL Period: Participants will receive fremanezumab once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.	Drug: Fremanezumab; Pharmaceutical form: solution for injection Route of administration: subcutaneous injection; Other Names: TEV-48125; Ajovy; Drug: Placebo; Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
Placebo Comparator: Placebo; DB Period: Participants will receive placebo once a month (approximately every 4 weeks). Participants will receive 3 placebo injections on Day 1, and a single injection of placebo on Days 29 and 57. OL Period: Participants will receive fremanezumab once a month (approximately every 4 weeks) administered as a single injection on Days 85, 113, and 141.	Drug: Placebo; Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Double Blind (DB) Period: Change From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab	Baseline Period (Day -28 to Day -1), Week 12

Secondary Outcome Measures

Outcome Measure	Time Frame
DB Period: Change From Baseline in the Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab	Baseline Period (Day -28 to Day -1), Up to Week 4
DB Period: 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	Baseline Period (Day -28 to Day -1), Up to Week 12
DB Period: Percentage of Participants Reaching at Least 50 Percent (%) Reduction From Baseline in Monthly Average Number of Migraine Days During the 12-Week Period After the First Dose of Fremanezumab	Baseline Period (Day -28 to Day-1), Up to Week 12
DB Period: 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	Baseline Period (Day -28 to Day -1), Up to Week 12
Number of Participants Who Experience Adverse Events (AEs)	Baseline Visit (Day 1), Up to Week 32
Number of Participants Who Do Not Complete the Study Due to Adverse Events	Up to Week 32
Number of Participants Who Receive Concomitant Medications	Baseline Visit (Day 1), Up to Week 32
Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA)	Baseline Visit (Day 1), Day 57, Day 169, Day 225
Assessment of Anti-Drug Antibodies in Plasma Level by Titer	Baseline Visit (Day 1), Day 57, Day 169, Day 225
Assessment of Anti-Drug Antibodies in Plasma Level by Kinetics	Baseline Visit (Day 1), Day 57, Day 169, Day 225
Assessment of Anti-Drug Antibodies in Plasma Level by Neutralizing Activities	Baseline Visit (Day 1), Day 57, Day 169, Day 225

Collaborators and Investigators

• Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
• Investigators: Study Director: Teva Medical Expert, MD, Teva Branded Pharmaceutical Products R&D, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Actual): January 31, 2024
• Study Completion (Estimated): July 3, 2024

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 7, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: TV48125-CNS-30088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No