A Study to Test the Effectiveness and Safety of Fremanezumab on Patients With Fibromyalgia

Study Purpose

The primary objective of the study is to estimate the treatment effect of fremanezumab administered subcutaneously in reducing pain in adult patients with FM. A secondary objective is to evaluate the effect of fremanezumab on other efficacy measures, including pain, quality of life, sleep, fatigue, improvement in health, physical functioning, and mood. Another secondary objective is to evaluate the safety and tolerability of fremanezumab administered subcutaneously in adult patients with FM. The total duration of patient participation in the study is planned to be 21 weeks, consisting of a screening period of up to 5 weeks (ranging from 17 to 35 days), and a double-blind treatment period of 16 weeks.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- approved for study participation by the Fibromyalgia Eligibility Review Committee.

- body mass index of 18.5 to 45 kg/m2 and a body weight ≥45 kg.

- agree to use only acetaminophen as rescue medication for FM-related pain (up to 1000 mg per dose and not to exceed 3000 mg/day for any indication throughout the study period) - non-pharmacologic interventions (including normal daily exercise routines, chiropractic care, physical therapy, psychotherapy, and massage therapy) are unchanged for a minimum of 30 days prior to screening and will remain unchanged throughout the study.

- agree to maintain a usual and unchanged physical exercise regimen.

- must be of nonchildbearing potential or , defined as: - women surgically sterile by documented complete hysterectomy, bilateral oophorectomy, or.

- bitubal ligations or confirmed to be postmenopausal (at least 1 year since last menstrual period) and.

- menopausal women confirmed by a follicle-stimulating hormone >35 U/L.

- men surgically sterile by documented vasectomy OR.

If of childbearing potential, patients must meet any of the following criteria:

- must use highly effective contraception method (Appendix G) with their partners during the entire study period and for 5 months after the last dose of the IMP.

- sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period.

- female patients of childbearing potential must have a negative serum beta-human chorionic gonadotropin (β-HCG) pregnancy test at screening (confirmed by urine dipstick β-HCG pregnancy test at baseline).

- must agree not to participate in another interventional study from the screening period through the EOS Visit o Additional criteria apply, please contact the investigator for more information.

Exclusion Criteria:

- unable or unwilling to discontinue/washout of prohibited medications.

- ongoing pain that would confound or interfere with the assessment of the patient's FM pain or require excluded therapies during the patient's participation in this study.

- surgery planned during the study period.

- receiving prophylactic treatment for migraine-related disorders, including topiramate, valproic acid, onabotulinumtoxinA, amitriptyline, and nortriptyline.

- known history of clinically significant or unstable hematologic, cardiac, or thromboembolic events.

- known history of suicide attempt, suicidal behavior, or suicidal ideation within the last 12 months.

- lifetime history of any psychotic and/or bipolar disorder.

- current, untreated, moderate or severe major depressive disorder and/or anxiety.

- known history of hypersensitivity reactions to injected proteins, including mAbs and animal venoms, or a history of Stevens-Johnson Syndrome/toxic epidermal necrolysis syndrome o Additional criteria apply, please contact the investigator for more information

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03965091
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Teva Branded Pharmaceutical Products R&D, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Teva Medical Expert, MD
Principal Investigator Affiliation	Teva Branded Pharmaceutical Products R&D, Inc.
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Fibromyalgia

Arms & Interventions

Arms

Experimental: Fremanezumab - Dose A

Experimental: Fremanezumab - Dose B

Placebo Comparator: Placebo

Interventions

Drug: - Fremanezumab - Dose A

Administered subcutaneously (sc) for 4 monthly doses at Visits 3, 4, 5, and 6.

Drug: - Fremanezumab - Dose B

Administered subcutaneously (sc) for 4 monthly doses at Visits 3, 4, 5, and 6.

Drug: - Placebo

Administered subcutaneously (sc) for 4 monthly doses at Visits 3, 4, 5, and 6.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Teva Investigational Site 14159, Birmingham, Alabama

Status

Recruiting

Address

Teva Investigational Site 14159

Birmingham, Alabama, 35216

Site Contact

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