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

NCT05458011 | Completed Phase 3 Results

• 1 other identifier: TV48125-CNS-30088
• Study Type: interventional
• Target: 365
• Locations: 1 country
• Sites: 29

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.

Conditions

Migraine

Outcome Measures

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

  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).

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

Secondary Outcomes (12)

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

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

• 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

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

• 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

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

• 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

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

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

  Week 0 up to Week 12

Study Arms (3)

Fremanezumab Monthly

EXPERIMENTAL

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; Drug: Placebo

Fremanezumab Quarterly

EXPERIMENTAL

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; Drug: Placebo

Placebo

PLACEBO COMPARATOR

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

Interventions

Fremanezumab DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Also known as: TEV-48125, Ajovy

Fremanezumab Monthly; Fremanezumab Quarterly

Placebo DRUG

Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Fremanezumab Monthly; Fremanezumab Quarterly; Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (29)

Teva Investigational Site 88028

Baotou Shi, 014060, China

Location

Teva Investigational Site 88004

Beijing, 100044, China

Location

Teva Investigational Site 88001

Beijing, 100853, China

Location

Teva Investigational Site 88008

Changchun, 130021, China

Location

Teva Investigational Site 88009

Changchun, 130041, China

Location

Teva Investigational Site 88022

Changsha Shi, 410008, China

Location

Teva Investigational Site 88030

Changsha Shi, 410013, China

Location

Teva Investigational Site 88003

Chengdu, 610041, China

Location

Teva Investigational Site 88029

Chongqing, 400700, China

Location

Teva Investigational Site 88019

Fuzhou, 350001, China

Location

Teva Investigational Site 88020

Guangzhou, 510260, China

Location

Teva Investigational Site 88013

Guiyang, 550004, China

Location

Teva Investigational Site 88026

Harbin, 150001, China

Location

Teva Investigational Site 88010

Lianyungang, 222002, China

Location

Teva Investigational Site 88005

Luoyang, 4710039, China

Location

Teva Investigational Site 88033

Rizhao, 276800, China

Location

Teva Investigational Site 88021

Shanghaishi, 200040, China

Location

Teva Investigational Site 88025

Shanghaishi, 200120, China

Location

Teva Investigational Site 88016

Shenyang, 110016, China

Location

Teva Investigational Site 88011

Shijiazhuang, 50073, China

Location

Teva Investigational Site 88015

Suzhou, 215004, China

Location

Teva Investigational Site 88024

Tianjin, 300052, China

Location

Teva Investigational Site 88023

Tianjin, 300120, China

Location

Teva Investigational Site 88017

Wenzhou, 325000, China

Location

Teva Investigational Site 88012

Wuhan, 430030, China

Location

Teva Investigational Site 88006

Wuhan, 430071, China

Location

Teva Investigational Site 88032

Xining, 810007, China

Location

Teva Investigational Site 88031

Zhanjiang, 524008, China

Location

Teva Investigational Site 88034

Zhengzhou, 450003, China

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

fremanezumab; erenumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

USMedInfo@tevapharm.com

888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 14, 2022
• Study Start: September 30, 2022
• Primary Completion: January 31, 2024
• Study Completion: June 13, 2024
• Last Updated: November 26, 2025
• Results First Posted: January 31, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (29)