NCT03285646: FACT CLBP 1

Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee

Terminated Phase 3 Results posted Last updated 30 June 2021

What this trial tests

Phase 3 trial testing Fasinumab in Chronic Low Back Pain in 63 participants. Terminated before completion.

Timeline

30 October 2017

Primary endpoint
5 May 2018

2 May 2019

Quick facts

Lead sponsor	Regeneron Pharmaceuticals
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	63
Start date	30 October 2017
Primary completion	5 May 2018
Estimated completion	2 May 2019
Sites	56 locations across United States

Drugs / interventions tested

• Fasinumab — full drug profile →
• Placebo

Conditions studied

• Chronic Low Back Pain — all drugs for Chronic Low Back Pain →
• Osteoarthritis — all drugs for Osteoarthritis →

Sponsor

Regeneron Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Chronic Low Back Pain or Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (NRS) Score Primary · Week 1, Week 2, Week 4, Week 8, Week 12, Week 16

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.

Change from Baseline to Week 1

Group	Value	95% CI
Fasinumab-matching Placebo	-0.73	± 1.424
Fasinumab 3 mg SC Q4W	-1.62	± 2.037

Change from Baseline to Week 2

Group	Value	95% CI
Fasinumab-matching Placebo	-0.98	± 1.588
Fasinumab 3 mg SC Q4W	-2.15	± 2.067

Change from Baseline to Week 4

Group	Value	95% CI
Fasinumab-matching Placebo	-1.28	± 1.878
Fasinumab 3 mg SC Q4W	-2.64	± 2.038

Change from Baseline to Week 8

Group	Value	95% CI
Fasinumab-matching Placebo	-1.21	± 1.568
Fasinumab 3 mg SC Q4W	-2.82	± 1.963

Change from Baseline to Week 12

Group	Value	95% CI
Fasinumab-matching Placebo	-2.12	± 1.582
Fasinumab 3 mg SC Q4W	-3.18	± 2.046

Change from Baseline to Week 16

Group	Value	95% CI
Fasinumab-matching Placebo	-0.77	± 1.943
Fasinumab 3 mg SC Q4W	-2.32	± 1.367

Change From Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) Total Score Secondary · Week 2, Week 4, Week 8, Week 12, Week 16

The RMDQ is a self-administered, 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 from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores are indicative of better function.

Change from Baseline to Week 2

Group	Value	95% CI
Fasinumab-matching Placebo	-2.70	± 5.120
Fasinumab 3 mg SC Q4W	-2.54	± 4.836

Change from Baseline to Week 4

Group	Value	95% CI
Fasinumab-matching Placebo	-1.92	± 4.529
Fasinumab 3 mg SC Q4W	-3.09	± 3.884

Change from Baseline to Week 8

Group	Value	95% CI
Fasinumab-matching Placebo	0.37	± 4.487
Fasinumab 3 mg SC Q4W	-4.18	± 5.015

Change from Baseline to Week 12

Group	Value	95% CI
Fasinumab-matching Placebo	0.83	± 3.061
Fasinumab 3 mg SC Q4W	-3.33	± 4.301

Change from Baseline to Week 16

Group	Value	95% CI
Fasinumab-matching Placebo	-1.00	± NA
Fasinumab 3 mg SC Q4W	-5.75	± 3.948

Change From Baseline to Week 16 in Patient Global Assessment (PGA) of Low Back Pain (LBP) Score Secondary · Week 2, Week 4, Week 8, Week 12, Week 16

The PGA of LBP is a participant assessed 5 point Likert scale of LBP ranging from 1-5 where 1 = very well; 2 = well; 3 = fair; 4 = poor; and 5 = very poor.

Change from Baseline to Week 2

Group	Value	95% CI
Fasinumab-matching Placebo	-0.44	± 0.751
Fasinumab 3 mg SC Q4W	-0.76	± 0.786

Change from Baseline to Week 4

Group	Value	95% CI
Fasinumab-matching Placebo	-0.60	± 0.957
Fasinumab 3 mg SC Q4W	-1.04	± 0.676

Change from Baseline to Week 8

Group	Value	95% CI
Fasinumab-matching Placebo	-0.55	± 0.945
Fasinumab 3 mg SC Q4W	-1.10	± 1.021

Change from Baseline to Week 12

Group	Value	95% CI
Fasinumab-matching Placebo	-0.57	± 1.134
Fasinumab 3 mg SC Q4W	-1.00	± 1.333

Change from Baseline to Week 16

Group	Value	95% CI
Fasinumab-matching Placebo	0.00	± NA
Fasinumab 3 mg SC Q4W	-0.75	± 0.500

Number of Participants Achieving ≥30% Reduction From Baseline to Week 16 in Average Daily LBPI NRS Score Secondary · Week 16

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.

Group	Value	95% CI
Fasinumab-matching Placebo	12
Fasinumab 3 mg SC Q4W	21

Change From Baseline to Week 16 in the Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Score Secondary · Week 2, Week 4, Week 8, Week 12, Week 16

The BPI-sf is a self-administered questionnaire for participants to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. With a recall period of 24 hours, the questionnaire contains the front and back body diagrams, the 4 pain severity items and 7 pain interference items rated on 0-10 scale; total interference score ranges from 0-10 (0, does not interfere; 10 completely interferes), and the question about percentage of pain relief by analgesics. The BPI pain interference is typically scored as the mean of the 7 interferen

Change from Baseline to Week 2

Group	Value	95% CI
Fasinumab-matching Placebo	-1.55	± 2.306
Fasinumab 3 mg SC Q4W	-1.94	± 2.255

Change from Baseline to Week 4

Group	Value	95% CI
Fasinumab-matching Placebo	-1.49	± 2.390
Fasinumab 3 mg SC Q4W	-2.15	± 2.157

Change from Baseline to Week 8

Group	Value	95% CI
Fasinumab-matching Placebo	-1.31	± 2.119
Fasinumab 3 mg SC Q4W	-2.70	± 2.774

Change from Baseline to Week 12

Group	Value	95% CI
Fasinumab-matching Placebo	-1.63	± 2.096
Fasinumab 3 mg SC Q4W	-1.84	± 1.978

Change from Baseline to Week 16

Group	Value	95% CI
Fasinumab-matching Placebo	-1.14	± NA
Fasinumab 3 mg SC Q4W	-1.29	± 3.017

Number of Adjudicated Arthropathy (AA) Events Secondary · Up to Week 36

Adjudicated arthropathy (AA) is a composite term that encompasses the following conditions: Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.

Group	Value	95% CI
Fasinumab-matching Placebo	0
Fasinumab 3 mg SC Q4W	2

Number of Adjudicated Arthropathy (AA) Events Meeting Destructive Arthropathy (DA) Criteria Secondary · Up to Week 36

Destructive arthropathy (DA) is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive Osteoarthritis type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis.

Group	Value	95% CI
Fasinumab-matching Placebo	0
Fasinumab 3 mg SC Q4W	0

Number of Treatment-Emergent Adverse Events (TEAEs) Secondary · Up to Week 16

Treatment-emergent adverse events (TEAEs) are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.

Group	Value	95% CI
Fasinumab-matching Placebo	33
Fasinumab 3 mg SC Q4W	14

Number of Sympathetic Nervous System (SNS) Dysfunction Events Secondary · Up to Week 36

Potential events of sympathetic nervous system (SNS) dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.

Group	Value	95% CI
Fasinumab-matching Placebo	0
Fasinumab 3 mg SC Q4W	0

Number of Peripheral Sensory Adverse Events (AEs) That Require a Neurology Consultation Secondary · Up to Week 36

Any peripheral sensory AE (eg, paraesthesia and hypoaesthesia) that required a neurology consultation.

Hypoaesthesia events

Group	Value	95% CI
Fasinumab-matching Placebo	1
Fasinumab 3 mg SC Q4W	0

Paraesthesia events

Group	Value	95% CI
Fasinumab-matching Placebo	1
Fasinumab 3 mg SC Q4W	0

Number of All-Cause Joint Replacement (JR) Surgery Events Secondary · Up to Week 36

All joint replacement surgery events regardless of cause.

Group	Value	95% CI
Fasinumab-matching Placebo	2
Fasinumab 3 mg SC Q4W	1

Number of Joint Replacement (JR) Surgery Events Reported at Telephone Survey After Last Dose of Study Drug Secondary · Up to Week 64

An end of study phone contact was conducted approximately 52 weeks following the last dose of study drug (week 12) to evaluate the number of participants who had undergone or were scheduled for JR surgery.

Group	Value	95% CI
Fasinumab-matching Placebo	0
Fasinumab 3 mg SC Q4W	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose of study drug up to 24 weeks post the last dose of study drug (up to week 36). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Fasinumab-matching Placebo

Serious: 1/32 (3%)

Deaths: 0/32

Fasinumab 3 mg SC Q4W

Serious: 2/31 (6%)

Deaths: 0/31

Serious adverse events (4 terms)

Reaction	System	Fasinumab-matching Placebo	Fasinumab 3 mg SC Q4W
Breast cancer stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Dizziness	Nervous system disorders	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Fasinumab-matching Placebo	Fasinumab 3 mg SC Q4W
Back pain	Musculoskeletal and connective tissue disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—
Blood creatine phosphokinase increased	Investigations	—	—
Neck Pain	Musculoskeletal and connective tissue disorders	—	—
Peripheral swelling	General disorders	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Breast cancer stage IV, Dizziness, Dyspnoea, Osteoarthritis.

Data from ClinicalTrials.gov NCT03285646 adverse events section.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibodies to watch in 2020.
   Kaplon H, Muralidharan M, Schneider Z, Reichert JM. · · 2020 · cited 332× · PMID 31847708 · DOI 10.1080/19420862.2019.1703531
2. Antibodies to watch in 2021.
   Kaplon H, Reichert JM. · · 2021 · cited 215× · PMID 33459118 · DOI 10.1080/19420862.2020.1860476
3. The emerging role of fibroblast-like synoviocytes-mediated synovitis in osteoarthritis: An update.
   Han D, Fang Y, Tan X, Jiang H, et al · · 2020 · cited 106× · PMID 32686306 · DOI 10.1111/jcmm.15669
4. New Trends in Pharmacological Treatments for Osteoarthritis.
   Cai X, Yuan S, Zeng Y, Wang C, et al · · 2021 · cited 68× · PMID 33935742 · DOI 10.3389/fphar.2021.645842
5. Challenges and opportunities of pharmacological interventions for osteoarthritis: A review of current clinical trials and developments.
   Vrouwe JPM, Burggraaf J, Kloppenburg M, Stuurman FE. · · 2021 · cited 16× · PMID 36474768 · DOI 10.1016/j.ocarto.2021.100212
6. An update on targets for treating osteoarthritis pain: NGF and TRPV1.
   Obeidat AM, Donner A, Miller RE. · · 2020 · cited 14× · PMID 34178580 · DOI 10.1007/s40674-020-00146-x
7. Identification of alkaline phosphatase as a putative biomarker of anti-NGF treatment-associated arthropathies: Machine learning-assisted analyses of clinical trial data.
   Wipperman MF, Ehmann PJ, McIntyre DAG, Wang CG, et al · · 2026 · PMID 41540988 · DOI 10.1016/j.ocarto.2025.100735