Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee
Public ClinicalTrials.gov record NCT03285646. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The primary objective of the study is to evaluate the efficacy of fasinumab in relieving Chronic low back pain (CLBP) as compared to placebo in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and Osteoarthritis (OA) of the knee or hip when treated for up to 16 weeks. The secondary objectives of the study are: To evaluate the safety and tolerability of fasinumab compared to placebo when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To characterize the concentrations of fasinumab in serum over time when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To evaluate the immunogenicity of fasinumab when treated for up to 16 weeks in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip.
Study identification
- NCT ID
- NCT03285646
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 63 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 29, 2017
- Primary completion
- May 4, 2018
- Completion
- May 1, 2019
- Last update posted
- Jun 29, 2021
2017 – 2019
United States locations
- U.S. sites
- 56
- U.S. states
- 27
- U.S. cities
- 50
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Regeneron Research Site | Phoenix | Arizona | 85053 | — |
| Regeneron Research Site | Tucson | Arizona | 85704 | — |
| Regeneron Research Site | Tucson | Arizona | 85712 | — |
| Regeneron Research Site | Anaheim | California | 92801 | — |
| Regeneron Research Site | Anaheim | California | 92805 | — |
| Regeneron Research Site | La Mesa | California | 91942 | — |
| Regeneron Research Site | North Hollywood | California | 91606 | — |
| Regeneron Research Site | San Diego | California | 92103 | — |
| Regeneron Research Site | San Marcos | California | 92078 | — |
| Regeneron Research Site | Santa Ana | California | 92703 | — |
| Regeneron Research Site | Spring Valley | California | 91978 | — |
| Regeneron Research Site | Whittier | California | 90602 | — |
| Regeneron Research Site | Stamford | Connecticut | 06905 | — |
| Regeneron Research Site | Waterbury | Connecticut | 06708 | — |
| Regeneron Research Site | Clearwater | Florida | 33756 | — |
| Regeneron Research Site | Hialeah | Florida | 33012 | — |
| Regeneron Research Site | Jacksonville | Florida | 32256 | — |
| Regeneron Research Site | Lauderdale Lakes | Florida | 33319 | — |
| Regeneron Research Site | Miami | Florida | 33155 | — |
| Regeneron Research Site | Ocoee | Florida | 34761 | — |
| Regeneron Research Site | Orlando | Florida | 32801 | — |
| Regeneron Research Site | Orlando | Florida | 32806 | — |
| Regeneron Research Site | Port Orange | Florida | 32127 | — |
| Regeneron Research Site | Sarasota | Florida | 34232 | — |
| Regeneron Research Site | Atlanta | Georgia | 30189 | — |
| Regeneron Research Site | Columbus | Georgia | 31904 | — |
| Regeneron Research Site #1 | Marietta | Georgia | 30060 | — |
| Regeneron Research Site #2 | Marietta | Georgia | 30060 | — |
| Regeneron Research Site | Newnan | Georgia | 30265 | — |
| Regeneron Research Site | Idaho Falls | Idaho | 83404 | — |
| Regeneron Research Site | Chicago | Illinois | 60602 | — |
| Regeneron Research Site | Chicago | Illinois | 60607 | — |
| Regeneron Research Site | Valparaiso | Indiana | 46383 | — |
| Regeneron Research Site | West Des Moines | Iowa | 50265 | — |
| Regeneron Research Site | Edgewood | Kentucky | 41017 | — |
| Regeneron Research Site | New Orleans | Louisiana | 70115 | — |
| Regeneron Research Site | Bay City | Michigan | 48706 | — |
| Regeneron Research Site | St Louis | Missouri | 63117 | — |
| Regeneron Research Site | Lincoln | Nebraska | 68516 | — |
| Regeneron Research Site | Las Vegas | Nevada | 89144 | — |
| Regeneron Research Site | Berlin | New Jersey | 08009 | — |
| Regeneron Research Site | Albuquerque | New Mexico | 87102 | — |
| Regeneron Research Site | Hartsdale | New York | 10530 | — |
| Regeneron Research Site | New York | New York | 10036 | — |
| Regeneron Research Site | High Point | North Carolina | 27262 | — |
| Regeneron Research Site | Fargo | North Dakota | 58105 | — |
| Regeneron Research Site | Beavercreek | Ohio | 45431 | — |
| Regeneron Research Site | Oklahoma City | Oklahoma | 73103 | — |
| Regeneron Research Site | Duncansville | Pennsylvania | 16635 | — |
| Regeneron Research Site | Rapid City | South Dakota | 57702 | — |
| Regeneron Research Site #1 | Memphis | Tennessee | 38119 | — |
| Regeneron Research Site #2 | Memphis | Tennessee | 38119 | — |
| Regeneron Research Site | Houston | Texas | 77058 | — |
| Regeneron Research Site | Katy | Texas | 77498 | — |
| Regeneron Research Site | Plano | Texas | 75075 | — |
| Regeneron Research Site | Kenosha | Wisconsin | 53144 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03285646, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 29, 2021 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT03285646 live on ClinicalTrials.gov.