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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003782-28 | EudraCT Number |
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The main objective of the trial is to evaluate the efficacy of fasinumab compared to placebo as measured by the change from baseline in the average daily Low Back Pain Intensity (LBPI) Numerical Rating Scale (NRS).
Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo as measured by:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasinumab 6 mg SC Q4W and Placebo IV Q8W | Experimental | Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8. |
|
| Fasinumab 9 mg SC Q4W and Placebo IV Q8W | Experimental | Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8. |
|
| Fasinumab 9 mg IV Q8W and Placebo SC Q4W | Experimental | Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12. |
|
| Placebo SC Q4W and Placebo IV Q8W | Experimental | Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasinumab | Drug | Participants received fasinumab SC or IV, Q4W or Q8W. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score | Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS) | Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
The study consisted of a screening period of up to 30 days & a 7-day pre-randomization period during which pain medication, except study-provided rescue medication, was discontinued. Confirmation of no exclusionary findings on joint on which imaging was performed during screening must have been received before a participant could be randomized.
The study was conducted at 105 sites in US, CA & EU from 26Jan2016 - 13Sep2017. Of 1,783 participants screened, 563 randomized to 1 of 4 groups stratified by baseline low back pain numerical rating scale (LBP NRS) score (<7, ≥7), duration of chronic LBP (<5, ≥5yrs) & max. Kellgren-Lawrence (K-L) score (≤2, >2) at any knee/ hip joint at screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo SC Q4W and Placebo IV Q8W | Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 26, 2016 | May 11, 2019 |
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|
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| placebo | Drug | Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W. |
|
| Baseline to Weeks 2, 4, 8, and 12 |
| Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score | The RMDQ is a self-administered, widely used health status measure for lower back pain (LBP). It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked - that is from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores indicative of better function. | Baseline to Week 16 |
| Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score | The PGA of LBP is a participant assessed 5 point Likert scale of LBP ranging from 0-5 where 1=very well; 2=well; 3=fair; 4=poor; and 5=very poor. | Baseline to Week 16 |
| Chandler |
| Arizona |
| United States |
| Glendale | Arizona | United States |
| Mesa | Arizona | United States |
| Phoenix | Arizona | United States |
| Scottsdale | Arizona | United States |
| Tucson | Arizona | United States |
| Little Rock | Arkansas | United States |
| Beverly Hills | California | United States |
| Carlsbad | California | United States |
| Lakewood | California | United States |
| Long Beach | California | United States |
| Sacramento | California | United States |
| San Diego | California | United States |
| Santa Rosa | California | United States |
| Vista | California | United States |
| Aurora | Colorado | United States |
| Colorado Springs | Colorado | United States |
| Littleton | Colorado | United States |
| Washington D.C. | District of Columbia | United States |
| Clearwater | Florida | United States |
| Fort Myers | Florida | United States |
| Leesburg | Florida | United States |
| Miami | Florida | United States |
| Orlando | Florida | United States |
| Chicago | Illinois | United States |
| Evansville | Indiana | United States |
| Council Bluffs | Iowa | United States |
| Worcester | Massachusetts | United States |
| Edina | Minnesota | United States |
| Kansas City | Missouri | United States |
| St Louis | Missouri | United States |
| Elkhorn | Nebraska | United States |
| Henderson | Nevada | United States |
| Las Vegas | Nevada | United States |
| Jamaica | New York | United States |
| New York | New York | United States |
| Williamsville | New York | United States |
| Cary | North Carolina | United States |
| High Point | North Carolina | United States |
| Raleigh | North Carolina | United States |
| Salisbury | North Carolina | United States |
| Wilmington | North Carolina | United States |
| Akron | Ohio | United States |
| Cincinnati | Ohio | United States |
| Columbus | Ohio | United States |
| Oklahoma City | Oklahoma | United States |
| Duncansville | Pennsylvania | United States |
| Anderson | South Carolina | United States |
| Greer | South Carolina | United States |
| Bristol | Tennessee | United States |
| Knoxville | Tennessee | United States |
| Cypress | Texas | United States |
| Dallas | Texas | United States |
| Lubbock | Texas | United States |
| Plano | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| London | Ontario | Canada |
| Toronto | Ontario | Canada |
| Prague | Czechia |
| Rychnov nad Kněžnou | Czechia |
| Aalborg | Denmark |
| Ballerup Municipality | Denmark |
| Tallinn | Estonia |
| Budapest | Hungary |
| Gyula | Hungary |
| Szolnok | Hungary |
| Bialystok | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Rzeszów | Poland |
| Warsaw | Poland |
| Zgierz | Poland |
| FG001 | Fasinumab 6 mg SC Q4W and Placebo IV Q8W | Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8. |
| FG002 | Fasinumab 9 mg SC Q4W and Placebo IV Q8W | Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8. |
| FG003 | Fasinumab 9 mg IV Q8W and Placebo SC Q4W | Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12. |
|
| Modified Intent to Treat Set (mITT) | mITT: Participants who received at least 1 dose of study drug & data up to 5 wks after last dose |
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| COMPLETED |
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| NOT COMPLETED |
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The full analysis set (FAS) included all randomized patients per Interactive voice response system (IVRS) and was based on the treatment allocated (as randomized).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo SC Q4W and Placebo IV Q8W | Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8. |
| BG001 | Fasinumab 6 mg SC Q4W and Placebo IV Q8W | Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8. |
| BG002 | Fasinumab 9 mg SC Q4W and Placebo IV Q8W | Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8. |
| BG003 | Fasinumab 9 mg IV Q8W and Placebo SC Q4W | Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Number | Participants |
| |||||||||||
| Low Back Pain Intensity Numerical Rating Scale (LBPI NRS) Baseline Score | Pre-randomization visit: Investigator recorded LBPI NRS score indicating pain intensity over past 24 hrs. per participant's report; Eligibility confirmed; LBPI NRS scores were reported by participant into electronic diary (EDiary) every day from pre-randomization to week 16; Avg. daily LBP: assessed on an 11-point numeric rating scale (NRS) defined as avg. of non-missing daily LBPI NRS scores for 7 days before, including nominal visit; Participants described avg. LBP during past 24 hrs. on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. | Full analysis set (FAS): included all randomized patients per IVRS and was based on the treatment allocated (as randomized). Baseline number analyzed = number of participants in FAS; number analyzed here = number of participants within a specified category. EDiary NRS data were missing for some participants at Baseline. | Mean | Standard Deviation | Scores on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score | Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. | Analysis performed on modified intent to treat set (mITT) included all randomized participants who received at least one dose of study drug based on the treatment allocated (as randomized) including data up to 5 weeks after the last dose of study drug. Number of participants analyzed = participants with available data for specified time point. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline to Week 16 |
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| Secondary | Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS) | Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. | Analysis performed on modified intent to treat set (mITT) included all randomized participants who received at least one dose of study drug based on the treatment allocated (as randomized) including data up to 5 weeks after the last dose of study drug. Number of participants analyzed = participants with available data for specified time point. | Posted | Least Squares Mean | Standard Error | Scores on a scale | Baseline to Weeks 2, 4, 8, and 12 |
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| Secondary | Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score | The RMDQ is a self-administered, widely used health status measure for lower back pain (LBP). It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked - that is from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores indicative of better function. | Analysis was performed on mITT population. Here, number of participants analyzed = participants with available data for specified time point. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline to Week 16 |
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| Secondary | Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score | The PGA of LBP is a participant assessed 5 point Likert scale of LBP ranging from 0-5 where 1=very well; 2=well; 3=fair; 4=poor; and 5=very poor. | Analysis was performed on mITT population. Here, number of participants analyzed=participants with available data for specified time point. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline to Week 16 |
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All Adverse Events (AEs) were collected from signature of the informed consent form up to the final visit (Week 36) regardless of seriousness or relationship to investigational product.
Safety analysis set (SAF): All randomized participants who received any study drug (based on treatment received [as treated]). Reported AEs & deaths are treatment emergent: AEs that developed/worsened & deaths that occurred during 'treatment emergent period' (from 1st dose of study drug up to 4 wks after last dose of SC drug, or 8 wks after last dose of IV study drug, whichever is later). Reported death occurred during post-treatment follow-up period in fasinumab 6 mg SC Q4W & placebo IV Q8W arm
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo SC Q4W and Placebo IV Q8W | Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8. Patients randomized to the 'Placebo SC Q4W and Placebo IV Q8W" treatment arm who wrongly received at least one dose of active treatment were classified in the active treatment group in the SAF. | 0 | 140 | 4 | 140 | 44 | 140 |
| EG001 | Fasinumab 6 mg SC Q4W and Placebo IV Q8W | Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8. Participants randomized to any of the active treatment groups receiving active fasinumab doses who wrongly received another dose of fasinumab were classified to the arm of the lowest dose of fasinumab received. For example, a participant randomized to the 'fasinumab 9 mg SC Q4W and placebo 9 mg IV Q8W' who wrongly received treatment with fasinumab 6 mg SC at least once was classified under the 'fasinumab 6 mg SC Q4W and placebo IV Q8W' treatment arm. | 1 | 139 | 2 | 139 | 35 | 139 |
| EG002 | Fasinumab 9 mg SC Q4W and Placebo IV Q8W | Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8. Participants randomized to any of the active treatment groups receiving active fasinumab doses who wrongly received another dose of fasinumab were classified to the arm of the lowest dose of fasinumab received. For example, a participant randomized to the 'fasinumab 9 mg SC Q4W and placebo 9 mg IV Q8W' who wrongly received treatment with fasinumab 6 mg SC at least once was classified under the 'fasinumab 6 mg SC Q4W and placebo IV Q8W' treatment arm. | 0 | 139 | 3 | 139 | 52 | 139 |
| EG003 | Fasinumab 9 mg IV Q8W and Placebo SC Q4W | Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12. Participants randomized to any of the active treatment groups receiving active fasinumab doses who wrongly received another dose of fasinumab were classified to the arm of the lowest dose of fasinumab received. For example, a participant randomized to the 'fasinumab 9 mg SC Q4W and placebo 9 mg IV Q8W' who wrongly received treatment with fasinumab 6 mg SC at least once was classified under the 'fasinumab 6 mg SC Q4W and placebo IV Q8W' treatment arm. | 0 | 140 | 5 | 140 | 49 | 140 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Craniocerebral injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Eye injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Skull fracture | Injury, poisoning and procedural complications | MedDRA 18.0 | Systematic Assessment |
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| Blood creatine phosphokinase increased | Investigations | MedDRA 18.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
| |
| Adenocarcinoma of colon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Tongue carcinoma stage IV | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Haemorrhagic stroke | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA 18.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA 18.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 18.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 18.0 | Systematic Assessment |
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FDA placed study on partial clinical hold. Sponsor did not amend the protocol and enrollment and dosing were not resumed. However randomized participants completed all remaining study visits/procedures per protocol except for dosing.
The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Administrator | Regeneron Pharmaceuticals | 844-734-6643 | clinicaltrials@regeneron.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 20, 2017 | May 11, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000626997 | fasinumab |
Not provided
Not provided
Not provided
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| ≥ 65 years |
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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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| 0.0180 |
Nominal p-value |
| LS Mean Difference |
| -0.7 |
| Standard Error of the Mean |
| 0.3 |
| 2-Sided |
| 95 |
| -1.32 |
| -0.12 |
| Superiority |
| Mixed Models Analysis | 0.0288 | Nominal p-value | LS Mean Difference | -0.7 | Standard Error of the Mean | 0.3 | 2-Sided | 95 | -1.26 | -0.07 | Superiority |
Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.
| OG002 | Fasinumab 9 mg SC Q4W and Placebo IV Q8W | Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8. |
| OG003 | Fasinumab 9 mg IV Q8W and Placebo SC Q4W | Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12. |
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| OG002 | Fasinumab 9 mg SC Q4W and Placebo IV Q8W | Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8. |
| OG003 | Fasinumab 9 mg IV Q8W and Placebo SC Q4W | Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12. |
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Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8. |
| OG003 | Fasinumab 9 mg IV Q8W and Placebo SC Q4W | Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12. |
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