Clinical trial NCT03965091: A Study to Test the Effectiveness and Safety of Fremanezumab on Participants With Fibromyalgia
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Proof of Concept Study of the Efficacy and Safety of Fremanezumab for Treatment of Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Fibromyalgia
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-28
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to estimate the treatment effect of fremanezumab administered subcutaneously (SC) in reducing pain in adult participants with fibromyalgia (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 SC in adult participants with FM.

The total duration of participant 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.


Eligibility criteria: Inclusion Criteria:

* approved for study participation by the Fibromyalgia Eligibility Review Committee
* body mass index of 18.5 to 45 kilograms (kg)/square meter (m\^2) 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 units (U)/liter (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 with their partners during the entire study period and for 5 months after the last dose of the study drug.
* sexual abstinence is only considered a highly effective method if defined as refraining from heterosexual intercourse in the defined period.
* female participants 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 end of study (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 participant's FM pain or require excluded therapies during the participant'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 monoclonal antibodies (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

Primary outcomes:
measure: Change From Baseline in the Weekly Average of the Daily Average Pain Intensity-Numerical Rating Scale (PI-NRS) Score Over the Past 24 Hours at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in the Individual Components of the Fibromyalgia Impact Questionnaire Revised (FIQR) Score: Symptom Subscore, Impact Subscore, and Functional Subscore at Week 12
timeFrame: Baseline, Week 12
measure: Responder Rate of the Patient Global Impression of Change (PGIC) Rating: Number of Participants Who Were Much Improved or Very Much Improved at Week 12
timeFrame: Week 12
measure: Number of Participants Who Experienced ≥30% Reduction From Baseline in Weekly Average of Daily Average PI-NRS Score at Week 12
timeFrame: Week 12
measure: Number of Participants Who Experienced ≥50% Reduction From Baseline in Weekly Average of Daily Average PI-NRS Score at Week 12
timeFrame: Week 12
measure: Change From Baseline in the Weekly Average of Daily Worst PI-NRS Score Over Past 24 Hours at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form (SF) 8a T-score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in the PROMIS Physical Function SF 12a Scale Score at Week 12
timeFrame: Baseline, Week 12
measure: Change From Baseline in the PROMIS Fatigue SF 8a T-Score at Week 12
timeFrame: Baseline, Week 12
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Baseline up to Week 16
measure: Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Serum Chemistry Value
timeFrame: Baseline up to Week 16
measure: Number of Participants With at Least 1 Potentially Clinically Significant Abnormal Hematology Value
timeFrame: Baseline up to Week 16
measure: Number of Participants With at Least 1 Potentially Clinically Significant Urinalysis Abnormalities
timeFrame: Baseline up to Week 16
measure: Number of Participants With at Least 1 Clinically Significant Abnormal Vital Signs Value
timeFrame: Baseline up to Week 16
measure: Number of Participants With at Least 1 Physical Examination Abnormal Finding
timeFrame: Baseline up to Week 16
measure: Number of Participants With Shift From Baseline to Endpoint in Electrocardiogram (ECG) Parameters
timeFrame: Baseline to Week 16
measure: Number of Participants With at Least 1 Injection Site AE
timeFrame: Baseline up to Week 16
measure: Number of Participants With Hypersensitivity/Anaphylaxis Reactions
timeFrame: Baseline up to Week 16
measure: Time to Withdrawal of Treatment Due to Lack of Efficacy
timeFrame: Baseline up to Week 16
measure: Time to Withdrawal of Treatment Due to AEs
timeFrame: Baseline up to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Teva Investigational Site 14159
state: Alabama
city: Huntsville
country: United States
facility: Teva Investigational Site 14174
state: Alabama
city: Mesa
country: United States
facility: Teva Investigational Site 14431
state: Arizona
city: Oceanside
country: United States
facility: Teva Investigational Site 14166
state: California
city: Panorama City
country: United States
facility: Teva Investigational Site 14435
state: California
city: Sacramento
country: United States
facility: Teva Investigational Site 14168
state: California
city: San Diego
country: United States
facility: Teva Investigational Site 14164
state: California
city: Torrance
country: United States
facility: Teva Investigational Site 14172
state: California
city: Stamford
country: United States
facility: Teva Investigational Site 14433
state: Connecticut
city: Ocala
country: United States
facility: Teva Investigational Site 14149
state: Florida
city: Oldsmar
country: United States
facility: Teva Investigational Site 14180
state: Florida
city: Plantation
country: United States
facility: Teva Investigational Site 14182
state: Florida
city: Tampa
country: United States
facility: Teva Investigational Site 14162
state: Florida
city: Marietta
country: United States
facility: Teva Investigational Site 14434
state: Georgia
city: Chicago
country: United States
facility: Teva Investigational Site 14148
state: Illinois
city: Flossmoor
country: United States
facility: Teva Investigational Site 14436
state: Illinois
city: Evansville
country: United States
facility: Teva Investigational Site 14155
state: Indiana
city: Overland Park
country: United States
facility: Teva Investigational Site 14176
state: Kansas
city: Wichita
country: United States
facility: Teva Investigational Site 14160
state: Kansas
city: Bowling Green
country: United States
facility: Teva Investigational Site 14429
state: Kentucky
city: North Dartmouth
country: United States
facility: Teva Investigational Site 14147
state: Massachusetts
city: Quincy
country: United States
facility: Teva Investigational Site 14157
state: Massachusetts
city: Ann Arbor
country: United States
facility: Teva Investigational Site 14163
state: Michigan
city: Hazelwood
country: United States
facility: Teva Investigational Site 14183
state: Missouri
city: O'Fallon
country: United States
facility: Teva Investigational Site 14170
state: Missouri
city: Springfield
country: United States
facility: Teva Investigational Site 14430
state: Missouri
city: Las Vegas
country: United States
facility: Teva Investigational Site 14165
state: Nevada
city: Albuquerque
country: United States
facility: Teva Investigational Site 14181
state: New Mexico
city: Raleigh
country: United States
facility: Teva Investigational Site 14152
state: North Carolina
city: Raleigh
country: United States
facility: Teva Investigational Site 14185
state: North Carolina
city: Salisbury
country: United States
facility: Teva Investigational Site 14437
state: North Carolina
city: Winston-Salem
country: United States
facility: Teva Investigational Site 14167
state: North Carolina
city: Fargo
country: United States
facility: Teva Investigational Site 14161
state: North Dakota
city: Cincinnati
country: United States
facility: Teva Investigational Site 14153
state: Ohio
city: Dayton
country: United States
facility: Teva Investigational Site 14432
state: Ohio
city: Portland
country: United States
facility: Teva Investigational Site 14171
state: Oregon
city: Salem
country: United States
facility: Teva Investigational Site 14175
state: Oregon
city: Allentown
country: United States
facility: Teva Investigational Site 14158
state: Pennsylvania
city: Duncansville
country: United States
facility: Teva Investigational Site 14177
state: Pennsylvania
city: Warwick
country: United States
facility: Teva Investigational Site 14156
state: Rhode Island
city: Knoxville
country: United States
facility: Teva Investigational Site 14173
state: Tennessee
city: Memphis
country: United States
facility: Teva Investigational Site 14150
state: Tennessee
city: Memphis
country: United States
facility: Teva Investigational Site 14151
state: Tennessee
city: Memphis
country: United States
facility: Teva Investigational Site 14178
state: Tennessee
city: Austin
country: United States
facility: Teva Investigational Site 14184
state: Texas
city: Dallas
country: United States
facility: Teva Investigational Site 14179
state: Texas
city: Salt Lake City
country: United States
facility: Teva Investigational Site 14169
state: Utah
city: Charlottesville
country: United States
facility: Teva Investigational Site 14146
state: Virginia
city: Kenosha
country: United States
facility: Teva Investigational Site 14154
state: Wisconsin
Study officials:
affiliation: Teva Branded Pharmaceutical Products R&D, Inc.
name: Teva Medical Expert, MD
role: STUDY_DIRECTOR
References: