Clinical trial NCT05458011: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-14
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: 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
timeFrame: Baseline (Day -28 to Day -1), up to Week 12
Secondary outcomes:
measure: DB Period: Mean Change From Baseline in the Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab
timeFrame: Baseline (Day -28 to Day -1), Up to Week 4
measure: 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
timeFrame: Baseline (Day -28 to Day -1), Up to Week 12
measure: 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
timeFrame: Baseline (Day -28 to Day-1), Up to Week 12
measure: 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
timeFrame: Baseline (Day -28 to Day -1), Up to Week 12
measure: DB Period: Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: Week 0 up to Week 12
measure: DB Period: Number of Participants Who Did Not Complete the Study Due to AEs
timeFrame: Week 0 up to Week 12
measure: OL Period: Number of Participants With at Least One TEAE
timeFrame: Week 12 up to Week 24
measure: OL Period: Number of Participants Who Did Not Complete the Study Due to AEs
timeFrame: Week 12 up to Week 24
measure: DB Period: Number of Participants Who Received Concomitant Medications for AEs
timeFrame: Week 0 up to Week 12
measure: OL Period: Number of Participants Who Received Concomitant Medications for AEs
timeFrame: Week 12 up to Week 24
measure: Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADA)
timeFrame: Day 1 up to Day 225
measure: Number of Participants With Treatment-Emergent Neutralizing Antibodies (NAbs)
timeFrame: Day 1 up to Day 225
Other outcomes:
Locations:
city: Baotou Shi
country: China
facility: Teva Investigational Site 88028
city: Beijing Shi
country: China
facility: Teva Investigational Site 88004
city: Beijing
country: China
facility: Teva Investigational Site 88001
city: Changchun
country: China
facility: Teva Investigational Site 88008
city: Changchun
country: China
facility: Teva Investigational Site 88009
city: Changsha Shi
country: China
facility: Teva Investigational Site 88022
city: Changsha Shi
country: China
facility: Teva Investigational Site 88030
city: Chengdu Shi
country: China
facility: Teva Investigational Site 88003
city: Chongqing
country: China
facility: Teva Investigational Site 88029
city: Fuzhou
country: China
facility: Teva Investigational Site 88019
city: Guangzhou Shi
country: China
facility: Teva Investigational Site 88020
city: Guiyang
country: China
facility: Teva Investigational Site 88013
city: Harbin Shi
country: China
facility: Teva Investigational Site 88026
city: Lianyungang
country: China
facility: Teva Investigational Site 88010
city: Luoyang
country: China
facility: Teva Investigational Site 88005
city: Rizhao
country: China
facility: Teva Investigational Site 88033
city: Shanghaishi
country: China
facility: Teva Investigational Site 88021
city: Shanghaishi
country: China
facility: Teva Investigational Site 88025
city: Shenyang Shi
country: China
facility: Teva Investigational Site 88016
city: Shijiazhuang Shi
country: China
facility: Teva Investigational Site 88011
city: Suzhou Shi
country: China
facility: Teva Investigational Site 88015
city: Tianjin Shi
country: China
facility: Teva Investigational Site 88024
city: Tianjin Shi
country: China
facility: Teva Investigational Site 88023
city: Wenzhou
country: China
facility: Teva Investigational Site 88017
city: Wuhan Shi
country: China
facility: Teva Investigational Site 88012
city: Wuhan Shi
country: China
facility: Teva Investigational Site 88006
city: Xining Shi
country: China
facility: Teva Investigational Site 88032
city: Zhanjiang
country: China
facility: Teva Investigational Site 88031
city: Zhengzhou Shi
country: China
facility: Teva Investigational Site 88034
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: