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

Primary Purpose

Migraine

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Fremanezumab
Placebo
Sponsored by
Teva Branded Pharmaceutical Products R&D, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 hepatitis B or C virus, or a known or suspected active infection of coronavirus disease 2019 (COVID-19).
  • 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.

Sites / Locations

  • Teva Investigational Site 88004Recruiting
  • Teva Investigational Site 88001Recruiting
  • Teva Investigational Site 88019Recruiting
  • Teva Investigational Site 88020Recruiting
  • Teva Investigational Site 88031Recruiting
  • Teva Investigational Site 88013Recruiting
  • Teva Investigational Site 88011Recruiting
  • Teva Investigational Site 88026Recruiting
  • Teva Investigational Site 88005Recruiting
  • Teva Investigational Site 88030Recruiting
  • Teva Investigational Site 88015Recruiting
  • Teva Investigational Site 88008Recruiting
  • Teva Investigational Site 88009Recruiting
  • Teva Investigational Site 88032Recruiting
  • Teva Investigational Site 88021Recruiting
  • Teva Investigational Site 88025Recruiting
  • Teva Investigational Site 88003Recruiting
  • Teva Investigational Site 88033Recruiting
  • Teva Investigational Site 88024Recruiting
  • Teva Investigational Site 88023Recruiting
  • Teva Investigational Site 88017Recruiting
  • Teva Investigational Site 88028Recruiting
  • Teva Investigational Site 88029Recruiting
  • Teva Investigational Site 88010Recruiting
  • Teva Investigational Site 88012Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Fremanezumab Monthly

Fremanezumab Quarterly

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

DB Period: Change From Baseline in the Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab
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
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
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
Number of Participants Who Experience Adverse Events (AEs)
Number of Participants Who Do Not Complete the Study Due to Adverse Events
Number of Participants Who Receive Concomitant Medications
Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA)
Assessment of Anti-Drug Antibodies in Plasma Level by Titer
Assessment of Anti-Drug Antibodies in Plasma Level by Kinetics
Assessment of Anti-Drug Antibodies in Plasma Level by Neutralizing Activities

Full Information

First Posted
July 11, 2022
Last Updated
June 2, 2023
Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05458011
Brief Title
A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period on Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2022 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Teva Branded Pharmaceutical Products R&D, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
372 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fremanezumab Monthly
Arm Type
Experimental
Arm Description
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.
Arm Title
Fremanezumab Quarterly
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fremanezumab
Other Intervention Name(s)
TEV-48125, Ajovy
Intervention Description
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
Primary Outcome Measure Information:
Title
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
Time Frame
Baseline Period (Day -28 to Day -1), Week 12
Secondary Outcome Measure Information:
Title
DB Period: Change From Baseline in the Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab
Time Frame
Baseline Period (Day -28 to Day -1), Up to Week 4
Title
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
Time Frame
Baseline Period (Day -28 to Day -1), Up to Week 12
Title
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
Time Frame
Baseline Period (Day -28 to Day-1), Up to Week 12
Title
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
Time Frame
Baseline Period (Day -28 to Day -1), Up to Week 12
Title
Number of Participants Who Experience Adverse Events (AEs)
Time Frame
Baseline Visit (Day 1), Up to Week 32
Title
Number of Participants Who Do Not Complete the Study Due to Adverse Events
Time Frame
Up to Week 32
Title
Number of Participants Who Receive Concomitant Medications
Time Frame
Baseline Visit (Day 1), Up to Week 32
Title
Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA)
Time Frame
Baseline Visit (Day 1), Day 57, Day 169, Day 225
Title
Assessment of Anti-Drug Antibodies in Plasma Level by Titer
Time Frame
Baseline Visit (Day 1), Day 57, Day 169, Day 225
Title
Assessment of Anti-Drug Antibodies in Plasma Level by Kinetics
Time Frame
Baseline Visit (Day 1), Day 57, Day 169, Day 225
Title
Assessment of Anti-Drug Antibodies in Plasma Level by Neutralizing Activities
Time Frame
Baseline Visit (Day 1), Day 57, Day 169, Day 225

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 hepatitis B or C virus, or a known or suspected active infection of coronavirus disease 2019 (COVID-19). 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Teva U.S. Medical Information
Phone
1-888-483-8279
Email
USMedInfo@tevapharm.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Teva Medical Expert, MD
Organizational Affiliation
Teva Branded Pharmaceutical Products R&D, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Teva Investigational Site 88004
City
Beijing Shi
State/Province
Beijing Sheng
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88001
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88019
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88020
City
Guangzhou Shi
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88031
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524008
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88013
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550004
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88011
City
Shijiazhuang Shi
State/Province
Hebei
ZIP/Postal Code
50073
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88026
City
Harbin Shi
State/Province
Heilongjiang
ZIP/Postal Code
150001
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88005
City
Luoyang
State/Province
Henan
ZIP/Postal Code
4710039
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88030
City
Changsha Shi
State/Province
Hunan Sheng
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88015
City
Suzhou Shi
State/Province
Jiangsu
ZIP/Postal Code
215004
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88008
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130021
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88009
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130041
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88032
City
Xining Shi
State/Province
Qinghai
ZIP/Postal Code
810007
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88021
City
Shanghaishi
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88025
City
Shanghaishi
State/Province
Shanghai
ZIP/Postal Code
200120
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88003
City
Chengdu Shi
State/Province
Sichuan Sheng
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88033
City
Rizhao
State/Province
Sichuan
ZIP/Postal Code
276800
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88024
City
Tianjin Shi
State/Province
Tianjin Sheng
ZIP/Postal Code
300052
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88023
City
Tianjin Shi
State/Province
Tianjin Sheng
ZIP/Postal Code
300120
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88017
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88028
City
Baotou Shi
ZIP/Postal Code
014060
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88029
City
Chongqing
ZIP/Postal Code
400700
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88010
City
Lianyungang
ZIP/Postal Code
222002
Country
China
Individual Site Status
Recruiting
Facility Name
Teva Investigational Site 88012
City
Wuhan Shi
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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