Phase 3
N=365
A Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Period on Efficacy and Safety of Fremanezumab in Chinese Adults With Migraine
Migraine
Bottom Line
View on ClinicalTrials.gov: NCT05458011 ↗Enrolled (actual)
365
Serious AEs
1.0%
Results posted
Jan 2025
Primary outcome: Primary: 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 — -2.8; -4.6 days/month — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fremanezumab (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
-2.8; -4.6 | <0.0001 sig |
| SECONDARY DB Period: Mean Change From Baseline in the Average Number of Migraine Days During the 4-Week Period After the First Dose of Fremanezumab |
-2.2; -4.5 | — |
| SECONDARY 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 |
-1.1; -3.0 | — |
| SECONDARY 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 |
63; 103 | — |
| SECONDARY 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 |
-2.4; -4.5 | — |
| SECONDARY DB Period: Number of Participants With At Least One Treatment-Emergent Adverse Event (TEAE) |
79; 48; 37 | — |
| SECONDARY DB Period: Number of Participants Who Did Not Complete the Study Due to AEs |
2; 1; 1 | — |
| SECONDARY OL Period: Number of Participants With at Least One TEAE |
78; 40; 38 | — |
| SECONDARY OL Period: Number of Participants Who Did Not Complete the Study Due to AEs |
1; 1; 1 | — |
| SECONDARY DB Period: Number of Participants Who Received Concomitant Medications for AEs |
51; 28; 23 | — |
| SECONDARY OL Period: Number of Participants Who Received Concomitant Medications for AEs |
46; 26; 30 | — |
| SECONDARY Number of Participants With Treatment Emergent Anti-Drug Antibodies (ADA) |
28; 11; 9 | — |
| SECONDARY Number of Participants With Treatment-Emergent Neutralizing Antibodies (NAbs) |
27; 11; 9 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05458011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.