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

NCT03965091 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: TV48125-PN-20028
• Study Type: interventional
• Target: 189
• Locations: 1 country
• Sites: 49

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.

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

• 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

  The PI-NRS is an 11-point pain intensity numerical rating scale where 0=no pain and 10=worst possible pain; higher scores indicating more pain. Weekly average of the daily average PI-NRS pain score over the past 24 hours was derived using formula: Summation of non-missing efficacy variable in an analysis week divided by the number of days with non-missing efficacy variable in the analysis week. Baseline was defined as the last 14 days before the first dose of study drug.

  Baseline, Week 12

Secondary Outcomes (19)

• 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

  Baseline, Week 12

• 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

  Week 12

• Number of Participants Who Experienced ≥30% Reduction From Baseline in Weekly Average of Daily Average PI-NRS Score at Week 12

  Week 12

• Number of Participants Who Experienced ≥50% Reduction From Baseline in Weekly Average of Daily Average PI-NRS Score at Week 12

  Week 12

• Change From Baseline in the Weekly Average of Daily Worst PI-NRS Score Over Past 24 Hours at Week 12

  Baseline, Week 12

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matching to fremanezumab SC on Days 1, 29, 57, and 85.

Drug: Placebo

Fremanezumab Dose A

EXPERIMENTAL

Participants will receive fremanezumab SC on Days 1, 29, and 57 and placebo matched to fremanezumab SC on Day 85.

Drug: Fremanezumab

Fremanezumab Dose B

EXPERIMENTAL

Participants will receive fremanezumab SC on Days 1, 29, and 57 and placebo matched to fremanezumab SC on Day 85.

Drug: Fremanezumab

Interventions

Fremanezumab DRUG

Fremanezumab will be administered per dose and schedule specified in the arm description.

Fremanezumab Dose A; Fremanezumab Dose B

Placebo DRUG

Placebo matching to fremanezumab will be administered per schedule specified in the arm description.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Teva Branded Pharmaceutical Products R&D, Inc.: lead

Study Sites (49)

Teva Investigational Site 14159

Birmingham, Alabama, 35216, United States

Location

Teva Investigational Site 14174

Huntsville, Alabama, 35801, United States

Location

Teva Investigational Site 14431

Mesa, Arizona, 85210, United States

Location

Teva Investigational Site 14166

Oceanside, California, 92056-4515, United States

Location

Teva Investigational Site 14435

Panorama City, California, 91402, United States

Location

Teva Investigational Site 14168

Sacramento, California, 95831, United States

Location

Teva Investigational Site 14164

San Diego, California, 92103, United States

Location

Teva Investigational Site 14172

Torrance, California, 90502, United States

Location

Teva Investigational Site 14433

Stamford, Connecticut, 06905, United States

Location

Teva Investigational Site 14149

Ocala, Florida, 34470, United States

Location

Teva Investigational Site 14180

Oldsmar, Florida, 34677, United States

Location

Teva Investigational Site 14182

Plantation, Florida, 33317, United States

Location

Teva Investigational Site 14162

Tampa, Florida, 33613-3923, United States

Location

Teva Investigational Site 14434

Marietta, Georgia, 30060, United States

Location

Teva Investigational Site 14148

Chicago, Illinois, 60634, United States

Location

Teva Investigational Site 14436

Flossmoor, Illinois, 60422, United States

Location

Teva Investigational Site 14155

Evansville, Indiana, 47714, United States

Location

Teva Investigational Site 14176

Overland Park, Kansas, 66210, United States

Location

Teva Investigational Site 14160

Wichita, Kansas, 67205, United States

Location

Teva Investigational Site 14429

Bowling Green, Kentucky, 42101, United States

Location

Teva Investigational Site 14147

North Dartmouth, Massachusetts, 02747, United States

Location

Teva Investigational Site 14157

Quincy, Massachusetts, 02169, United States

Location

Teva Investigational Site 14163

Ann Arbor, Michigan, 48104, United States

Location

Teva Investigational Site 14183

Hazelwood, Missouri, 63042, United States

Location

Teva Investigational Site 14170

O'Fallon, Missouri, 63368, United States

Location

Teva Investigational Site 14430

Springfield, Missouri, 65810, United States

Location

Teva Investigational Site 14165

Las Vegas, Nevada, 89102, United States

Location

Teva Investigational Site 14181

Albuquerque, New Mexico, 87109, United States

Location

Teva Investigational Site 14152

Raleigh, North Carolina, 27609, United States

Location

Teva Investigational Site 14185

Raleigh, North Carolina, 27612, United States

Location

Teva Investigational Site 14437

Salisbury, North Carolina, 28144, United States

Location

Teva Investigational Site 14167

Winston-Salem, North Carolina, 27103, United States

Location

Teva Investigational Site 14161

Fargo, North Dakota, 58104, United States

Location

Teva Investigational Site 14153

Cincinnati, Ohio, 45219, United States

Location

Teva Investigational Site 14432

Dayton, Ohio, 45432, United States

Location

Teva Investigational Site 14171

Portland, Oregon, 97214, United States

Location

Teva Investigational Site 14175

Salem, Oregon, 97301, United States

Location

Teva Investigational Site 14158

Allentown, Pennsylvania, 18104, United States

Location

Teva Investigational Site 14177

Duncansville, Pennsylvania, 16635, United States

Location

Teva Investigational Site 14156

Warwick, Rhode Island, 02886, United States

Location

Teva Investigational Site 14173

Knoxville, Tennessee, 37938, United States

Location

Teva Investigational Site 14150

Memphis, Tennessee, 38119, United States

Location

Teva Investigational Site 14151

Memphis, Tennessee, 38119, United States

Location

Teva Investigational Site 14178

Memphis, Tennessee, 38119, United States

Location

Teva Investigational Site 14184

Austin, Texas, 78756, United States

Location

Teva Investigational Site 14179

Dallas, Texas, 75231, United States

Location

Teva Investigational Site 14169

Salt Lake City, Utah, 84102, United States

Location

Teva Investigational Site 14146

Charlottesville, Virginia, 22911, United States

Location

Teva Investigational Site 14154

Kenosha, Wisconsin, 53144, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

fremanezumab

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Director, Clinical Research
• Organization: Teva Branded Pharmaceutical Products, R&D Inc.

USMedInfo@tevapharm.com

888-483-8279

Study Officials

• Teva Medical Expert, MD

  Teva Branded Pharmaceutical Products R&D, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: July 31, 2019
• Primary Completion: January 19, 2022
• Study Completion: January 19, 2022
• Last Updated: March 30, 2023
• Results First Posted: March 30, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

US (49)