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

NCT ID: NCT05458011

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 365 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2024-06-13

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.

Conditions

Migraine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Fremanezumab

Intervention Type: DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Placebo

Intervention Type: DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

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.

Group Type: EXPERIMENTAL

Fremanezumab

Intervention Type: DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Placebo

Intervention Type: DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Interventions

Fremanezumab

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Intervention Type: DRUG

Placebo

Pharmaceutical form: solution for injection

Route of administration: subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

TEV-48125; Ajovy

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Teva Branded Pharmaceutical Products R&D, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Teva Medical Expert, MD

Role: STUDY_DIRECTOR

Teva Branded Pharmaceutical Products R&D, Inc.

Locations

Teva Investigational Site 88028

Baotou Shi, , China

Teva Investigational Site 88004

Beijing, , China

Teva Investigational Site 88001

Beijing, , China

Teva Investigational Site 88008

Changchun, , China

Teva Investigational Site 88009

Changchun, , China

Teva Investigational Site 88022

Changsha Shi, , China

Teva Investigational Site 88030

Changsha Shi, , China

Teva Investigational Site 88003

Chengdu, , China

Teva Investigational Site 88029

Chongqing, , China

Teva Investigational Site 88019

Fuzhou, , China

Teva Investigational Site 88020

Guangzhou, , China

Teva Investigational Site 88013

Guiyang, , China

Teva Investigational Site 88026

Harbin, , China

Teva Investigational Site 88010

Lianyungang, , China

Teva Investigational Site 88005

Luoyang, , China

Teva Investigational Site 88033

Rizhao, , China

Teva Investigational Site 88021

Shanghaishi, , China

Teva Investigational Site 88025

Shanghaishi, , China

Teva Investigational Site 88016

Shenyang, , China

Teva Investigational Site 88011

Shijiazhuang, , China

Teva Investigational Site 88015

Suzhou, , China

Teva Investigational Site 88024

Tianjin, , China

Teva Investigational Site 88023

Tianjin, , China

Teva Investigational Site 88017

Wenzhou, , China

Teva Investigational Site 88012

Wuhan, , China

Teva Investigational Site 88006

Wuhan, , China

Teva Investigational Site 88032

Xining, , China

Teva Investigational Site 88031

Zhanjiang, , China

Teva Investigational Site 88034

Zhengzhou, , China

Countries

China

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TV48125-CNS-30088

Identifier Type: -

Identifier Source: org_study_id