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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05458011
• Other study ID #: TV48125-CNS-30088
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: August 23, 2022
• Est. completion date: July 3, 2024

Study information

• Verified date: February 2024
• Source: Teva Branded Pharmaceutical Products R&D, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 365
• Est. completion date: July 3, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Fremanezumab
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection
• Placebo
Pharmaceutical form: solution for injection Route of administration: subcutaneous injection

Locations

Country	Name	City	State
China	Teva Investigational Site 88028	Baotou Shi
China	Teva Investigational Site 88001	Beijing
China	Teva Investigational Site 88004	Beijing Shi
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 Shi
China	Teva Investigational Site 88029	Chongqing
China	Teva Investigational Site 88019	Fuzhou
China	Teva Investigational Site 88020	Guangzhou Shi
China	Teva Investigational Site 88013	Guiyang
China	Teva Investigational Site 88026	Harbin Shi
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 Shi
China	Teva Investigational Site 88011	Shijiazhuang Shi
China	Teva Investigational Site 88015	Suzhou Shi
China	Teva Investigational Site 88023	Tianjin Shi
China	Teva Investigational Site 88024	Tianjin Shi
China	Teva Investigational Site 88017	Wenzhou
China	Teva Investigational Site 88006	Wuhan Shi
China	Teva Investigational Site 88012	Wuhan Shi
China	Teva Investigational Site 88032	Xining Shi
China	Teva Investigational Site 88031	Zhanjiang
China	Teva Investigational Site 88034	Zhengzhou Shi

Sponsors (1)

Lead Sponsor	Collaborator
Teva Branded Pharmaceutical Products R&D, Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Number of Participants Who Experience Adverse Events (AEs)		Baseline Visit (Day 1), Up to Week 32
Secondary	Number of Participants Who Do Not Complete the Study Due to Adverse Events		Up to Week 32
Secondary	Number of Participants Who Receive Concomitant Medications		Baseline Visit (Day 1), Up to Week 32
Secondary	Number of Participants with Treatment Emergent Anti-Drug Antibodies (ADA)		Baseline Visit (Day 1), Day 57, Day 169, Day 225
Secondary	Assessment of Anti-Drug Antibodies in Plasma Level by Titer		Baseline Visit (Day 1), Day 57, Day 169, Day 225
Secondary	Assessment of Anti-Drug Antibodies in Plasma Level by Kinetics		Baseline Visit (Day 1), Day 57, Day 169, Day 225
Secondary	Assessment of Anti-Drug Antibodies in Plasma Level by Neutralizing Activities		Baseline Visit (Day 1), Day 57, Day 169, Day 225