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CompletedNCT02683239FACT LTS & OAUpdated Oct 13, 2023Results posted

Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip

A Phase 3 interventional study of Fasinumab and Placebo in Osteoarthritis of the Knee or Hip, sponsored by Regeneron Pharmaceuticals. Completed at 150 sites in 21 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-13.

Sponsored by Regeneron Pharmaceuticals · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
5,331
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of the study is to describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed OA of the knee or hip.

02

Conditions studied

  • Osteoarthritis of the Knee or Hip
03

In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 5,331 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 400 studies on the registry; 91 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  1. Male or female ≥18 years of age at the screening visit
  2. Clinical diagnosis of OA of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2) for the index joint at the screening visit
  3. Moderate to severe pain in the index joint defined as a Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) average pain subscale score of ≥4
  4. A history of 12 weeks of analgesic use for OA of the knee or hip
  5. History of regular use of analgesic medications for OA pain

Key Exclusion Criteria:

  1. History or presence at the screening visit of non OA inflammatory joint disease
  2. History or presence on imaging of arthropathy, stress fracture, recent stress fracture, neuropathic joint arthropathy, hip dislocation, knee dislocation, congenital hip dysplasia with degenerative joint disease, extensive subchondral cysts, evidence of bone fragmentation or collapse, or primary metastatic tumor with the exception of chondromas or pathologic fracture during the screening period
  3. Signs or symptoms of carpal tunnel syndrome within 6 months of screening
  4. Patient is not a candidate for MRI
  5. Is scheduled for a joint replacement surgery to be performed during the study period
  6. Systemic (i.e., oral or intramuscular) corticosteroids within 30 days prior to the screening visit.
  7. History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
  8. History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
  9. Pregnant or breast-feeding women
  10. Women of childbearing potential who have a positive pregnancy test result or do not have their pregnancy test result at baseline

Note: Other protocol defined Inclusion/Exclusion criteria apply

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
5,331 participants (actual)

Study arms

  • Experimental
    Fasinumab dosing regimen 1

    Drug: Fasinumab

  • Experimental
    Fasinumab dosing regimen 2

    Drug: Fasinumab

  • Experimental
    Placebo

    Drug: Placebo

Interventions

  • DrugFasinumab

    Participants will receive sub-cutaneous (SC) injections of fasinumab

    Also known as: REGN475

  • DrugPlacebo

    Participants will receive sub-cutaneous (SC) injections of matching placebo

06

What researchers measure

Primary outcomes

  1. Number of Participants With Any Treatment-Emergent Adverse Event (TEAE)

    Time frame: Baseline up to week 52

  2. Number of Participants With Any Serious TEAE

    Time frame: Baseline up to week 52

  3. Number of Participants With Any Adverse Event (AE) up to Week 72

    Time frame: Baseline up to week 72

  4. Number of Participants With Any Serious AE up to Week 72

    Time frame: Baseline up to week 72

  5. Number of Participants With Adjudicated Arthropathy (AA)

    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.

    Time frame: Baseline up to week 52 and week 72

  6. Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria

    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 OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.

    Time frame: Baseline up to week 52 and week 72

  7. Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation

    Any participant with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an adverse event of special interest (AESI).

    Time frame: Baseline up to week 72

  8. Number of Participants With Sympathetic Nervous System (SNS) Dysfunction

    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.

    Time frame: Baseline up to week 72

  9. Number of Participants With at Least One All-Cause Joint Replacement (JR) Surgery

    All joint replacement surgery events regardless of cause at weeks 52 and 72. An end of study phone contact was also conducted approximately 52 weeks following the last dose of study drug.

    Time frame: Baseline up to weeks 52, 72, and end of study (52 weeks post last dose)

  10. Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52

    Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the treatment period were reported. Clinical significance was determined by the investigator.

    Time frame: Baseline to week 52

  11. Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-Treatment up to Week 72

    Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the post-treatment period were reported. Clinical significance was determined by the investigator.

    Time frame: End of treatment up to week 72

  12. Number of Participants With Anti-drug Antibody (ADA) up to Week 72

    Immunogenicity was characterized by ADA responses \& titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses less than (\<) 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, greater than or equal to (≥) 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the fasinumab ADA assay post first dose when baseline results = negative or missing.

    Time frame: Baseline up to week 72

  13. Change From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Time frame: Baseline to Week 16

  14. Change From Baseline to Week 16 in WOMAC Physical Function Subscale Score

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

    Time frame: Baseline to Week 16

Secondary outcomes

  1. Change From Baseline to Week 16 in Patient Global Assessment (PGA) Score of Osteoarthritis

    The PGA of OA is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).

    Time frame: Baseline to Week 16

  2. Number of Participants With ≥30% Reduction From Baseline to Week 16 in the WOMAC Pain Subscale Score

    The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. Participants who achieved a response, where response was defined as an improvement by ≥30% in WOMAC pain subscale score

    Time frame: Baseline to Week 16

07

Results

Posted Oct 13, 2023

Participant flow

Participant flow — Overall Study
MilestoneFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4W
Started12609719752141680116115
Completed800738756949355644
Not completed4602332191207456071
Withdrew: Protocol violation35232643545
Withdrew: Adverse event6439421618999
Withdrew: Physician decision381914731431415
Withdrew: Withdrawal by subject1879991182482228
Withdrew: Lost to follow-up772425788811
Withdrew: Death95801210
Withdrew: Lack of efficacy50231222923
Withdrew: Missing data0110100

Outcome measures

PrimaryNumber of Participants With Any Treatment-Emergent Adverse Event (TEAE)
Time frame:
Baseline up to week 52
Reported as:
Count of participants · Participants
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE)
ParticipantsFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4W
Number of Participants With Any Treatment-Emergent Adverse Event (TEAE)105584088518514879392
PrimaryNumber of Participants With Any Serious TEAE
Time frame:
Baseline up to week 52
Reported as:
Count of participants · Participants
Number of Participants With Any Serious TEAE
ParticipantsFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4W
Number of Participants With Any Serious TEAE8257701310753
PrimaryNumber of Participants With Any Adverse Event (AE) up to Week 72
Time frame:
Baseline up to week 72
Reported as:
Count of participants · Participants
Number of Participants With Any Adverse Event (AE) up to Week 72
ParticipantsFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4W
Number of Participants With Any Adverse Event (AE) up to Week 7211128679021921570106106
PrimaryNumber of Participants With Any Serious AE up to Week 72
Time frame:
Baseline up to week 72
Reported as:
Count of participants · Participants
Number of Participants With Any Serious AE up to Week 72
ParticipantsFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4W
Number of Participants With Any Serious AE up to Week 72173138176444132826
PrimaryNumber of Participants With Adjudicated Arthropathy (AA)

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.

Time frame:
Baseline up to week 52 and week 72
Reported as:
Count of participants · Participants
Number of Participants With Adjudicated Arthropathy (AA)
ParticipantsFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4W
Week 5223526225238148
Week 72327189273031813
PrimaryNumber of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria

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 OA type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis confirmed by an arthropathy adjudication committee.

Time frame:
Baseline up to week 52 and week 72
Reported as:
Count of participants · Participants
Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria
ParticipantsFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4W
Week 5201312011
Week 7201513111
PrimaryNumber of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation

Any participant with a peripheral sensory event that persisted for 2 months was referred for a neurology or other specialty consultation and reported as an adverse event of special interest (AESI).

Time frame:
Baseline up to week 72
Reported as:
Count of participants · Participants
Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation
ParticipantsFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4W
Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation296562217531
PrimaryNumber of Participants With Sympathetic Nervous System (SNS) Dysfunction

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.

Time frame:
Baseline up to week 72
Reported as:
Count of participants · Participants
Number of Participants With Sympathetic Nervous System (SNS) Dysfunction
ParticipantsFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4W
Number of Participants With Sympathetic Nervous System (SNS) Dysfunction0000100
PrimaryNumber of Participants With at Least One All-Cause Joint Replacement (JR) Surgery

All joint replacement surgery events regardless of cause at weeks 52 and 72. An end of study phone contact was also conducted approximately 52 weeks following the last dose of study drug.

Time frame:
Baseline up to weeks 52, 72, and end of study (52 weeks post last dose)
Reported as:
Count of participants · Participants
Number of Participants With at Least One All-Cause Joint Replacement (JR) Surgery
ParticipantsFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4W
Week 523727371510984
Week 7255557123197119
End of Study (52 weeks post-last dose)7981118303091815
PrimaryNumber of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52

Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the treatment period were reported. Clinical significance was determined by the investigator.

Time frame:
Baseline to week 52
Reported as:
Count of participants · Participants
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52
ParticipantsFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4W
Hematology19523624128304711
Chemistry4033654031057173634
Urinalysis32424525511
PrimaryNumber of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-Treatment up to Week 72

Number of participants with potentially clinically significant abnormal values in hematology, chemistry, and urinalysis during the post-treatment period were reported. Clinical significance was determined by the investigator.

Time frame:
End of treatment up to week 72
Reported as:
Count of participants · Participants
Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-Treatment up to Week 72
ParticipantsFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4W
Hematology171149154232792932
Chemistry267228225594743640
Urinalysis16241813753
PrimaryNumber of Participants With Anti-drug Antibody (ADA) up to Week 72

Immunogenicity was characterized by ADA responses \& titers. Responses categories: Negative - ADA negative response at all time points, regardless of missing samples; Pre-existing immunoreactivity - ADA positive response at baseline with all post first dose negative results or positive response at baseline with all post first dose ADA responses less than (\<) 9-fold over baseline titer levels; Treatment-boosted response - positive response in the assay post first dose, greater than or equal to (≥) 9-fold over baseline titer levels, when baseline results are positive; Treatment-emergent response - ADA positive response in the fasinumab ADA assay post first dose when baseline results = negative or missing.

Time frame:
Baseline up to week 72
Reported as:
Count of participants · Participants
Number of Participants With Anti-drug Antibody (ADA) up to Week 72
ParticipantsFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4W
ADA Negative Status11158859072001547108104
Pre-existing Immunoreactivity22161263721
Treatment-Boosted Response0000000
Treatment-Emergent Response16101021910
PrimaryChange From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

Time frame:
Baseline to Week 16
Reported as:
Least squares mean · Score on a Scale
Change From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score
Score on a ScaleFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8W
Change From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score-1.55 ± 0.178-2.28 ± 0.175-2.77 ± 0.171-2.78 ± 0.174-2.59 ± 0.174
Statistical analysis
  • Fasinumab-matching Placebo Q4W/Q8W vs Fasinumab 1 mg SC Q8W · Mixed Models Analysis · p = = 0.0010 · Least squares mean: -0.73 · 95% CI -1.159 to -0.293
  • Fasinumab-matching Placebo Q4W/Q8W vs Fasinumab 1 mg SC Q4W · Mixed Models Analysis · p = < 0.0001 · Least squares mean: -1.22 · 95% CI -1.646 to -0.793
  • Fasinumab-matching Placebo Q4W/Q8W vs Fasinumab 3 mg SC Q4W · Mixed Models Analysis · p = < 0.0001 · Least squares mean: -1.23 · 95% CI -1.664 to -0.793
  • Fasinumab-matching Placebo Q4W/Q8W vs Fasinumab 6 mg SC Q8W · Mixed Models Analysis · p = < 0.0001 · Least squares mean: -1.04 · 95% CI -1.477 to -0.606
PrimaryChange From Baseline to Week 16 in WOMAC Physical Function Subscale Score

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

Time frame:
Baseline to Week 16
Reported as:
Least squares mean · Score on a Scale
Change From Baseline to Week 16 in WOMAC Physical Function Subscale Score
Score on a ScaleFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8W
Change From Baseline to Week 16 in WOMAC Physical Function Subscale Score-1.35 ± 0.177-2.09 ± 0.175-2.55 ± 0.173-2.61 ± 0.177-2.48 ± 0.177
Statistical analysis
  • Fasinumab-matching Placebo Q4W/Q8W vs Fasinumab 1 mg SC Q8W · Mixed Models Analysis · p = = 0.0007 · Least squares mean: -0.74 · 95% CI -1.163 to -0.309
  • Fasinumab-matching Placebo Q4W/Q8W vs Fasinumab 1 mg SC Q4W · Mixed Models Analysis · p = < 0.0001 · Least squares mean: -1.20 · 95% CI -1.624 to -0.768
  • Fasinumab-matching Placebo Q4W/Q8W vs Fasinumab 3 mg SC Q4W · Mixed Models Analysis · p = < 0.0001 · Least squares mean: -1.26 · 95% CI -1.698 to -0.822
  • Fasinumab-matching Placebo Q4W/Q8W vs Fasinumab 6 mg SC Q8W · Mixed Models Analysis · p = < 0.0001 · Least squares mean: -1.13 · 95% CI -1.564 to -0.695
SecondaryChange From Baseline to Week 16 in Patient Global Assessment (PGA) Score of Osteoarthritis

The PGA of OA is a patient-rated assessment of current disease state on a 5-point Likert scale (1 = very good; 2 = good; 3 = fair; 4 = poor; and 5 = very poor).

Time frame:
Baseline to Week 16
Reported as:
Least squares mean · Score on a Scale
Change From Baseline to Week 16 in Patient Global Assessment (PGA) Score of Osteoarthritis
Score on a ScaleFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8W
Change From Baseline to Week 16 in Patient Global Assessment (PGA) Score of Osteoarthritis-0.66 ± 0.070-0.87 ± 0.071-0.93 ± 0.069-0.99 ± 0.071-0.96 ± 0.072
Statistical analysis
  • Fasinumab-matching Placebo Q4W/Q8W vs Fasinumab 1 mg SC Q8W · Mixed Models Analysis · p = = 0.0230 · Least squares mean: -0.20 · 95% CI -0.380 to -0.028
  • Fasinumab-matching Placebo Q4W/Q8W vs Fasinumab 1 mg SC Q4W · Mixed Models Analysis · p = = 0.0025 · Least squares mean: -0.27 · 95% CI -0.437 to -0.093
  • Fasinumab-matching Placebo Q4W/Q8W vs Fasinumab 3 mg SC Q4W · Mixed Models Analysis · p = = 0.0003 · Least squares mean: -0.32 · 95% CI -0.496 to -0.145
  • Fasinumab-matching Placebo Q4W/Q8W vs Fasinumab 6 mg SC Q8W · Mixed Models Analysis · p = = 0.0010 · Least squares mean: -0.29 · 95% CI -0.466 to -0.118
SecondaryNumber of Participants With ≥30% Reduction From Baseline to Week 16 in the WOMAC Pain Subscale Score

The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations. Participants who achieved a response, where response was defined as an improvement by ≥30% in WOMAC pain subscale score

Time frame:
Baseline to Week 16
Reported as:
Count of participants · Participants
Number of Participants With ≥30% Reduction From Baseline to Week 16 in the WOMAC Pain Subscale Score
ParticipantsFasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8W
Number of Participants With ≥30% Reduction From Baseline to Week 16 in the WOMAC Pain Subscale Score76108126118114

Adverse events

Collected over From time of randomization to end of post follow-up period (Week 100). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fasinumab-matching Placebo Q4W/Q8W9/1,257 (0.7%)183/1,257 (14.6%)988/1,257 (78.6%)
Fasinumab 1mg SC Q8W5/966 (0.5%)146/966 (15.1%)793/966 (82.1%)
Fasinumab 1mg SC Q4W8/974 (0.8%)186/974 (19.1%)817/974 (83.9%)
Fasinumab 3mg SC Q4W0/214 (0%)51/214 (23.8%)181/214 (84.6%)
Fasinumab 6mg SC Q8W12/1,677 (0.7%)441/1,677 (26.3%)1,447/1,677 (86.3%)
Fasinumab 6mg SC Q4W1/116 (0.9%)29/116 (25%)95/116 (81.9%)
Fasinumab 9mg SC Q4W0/115 (0%)26/115 (22.6%)88/115 (76.5%)
Most frequent serious events
Showing 10 of 428
Most frequent serious events
EventFasinumab-matching Placebo Q4W/Q8WFasinumab 1mg SC Q8WFasinumab 1mg SC Q4WFasinumab 3mg SC Q4WFasinumab 6mg SC Q8WFasinumab 6mg SC Q4WFasinumab 9mg SC Q4W
Rapidly progressive osteoarthritisMusculoskeletal and connective tissue disorders8/125723/96627/97410/214157/16778/1166/115
OsteoarthritisMusculoskeletal and connective tissue disorders12/125711/96618/9748/21443/16774/1161/115
ArthralgiaMusculoskeletal and connective tissue disorders17/125716/96623/9745/21457/16773/1162/115
Knee arthroplastySurgical and medical procedures14/125714/96614/9745/21430/16771/1161/115
Carpal tunnel syndromeNervous system disorders2/12572/9662/9740/2145/16770/1162/115
Subchondral insufficiency fractureMusculoskeletal and connective tissue disorders0/12571/9661/9740/21421/16772/1161/115
Ischaemic strokeNervous system disorders0/12571/9661/9740/2141/16772/1160/115
Hip arthroplastySurgical and medical procedures9/12578/9669/9741/2144/16772/1160/115
Atrial fibrillationCardiac disorders3/12571/9662/9743/2146/16770/1160/115
Muscular weaknessMusculoskeletal and connective tissue disorders1/12570/9660/9742/2141/16770/1160/115
Most frequent other events
Showing 10 of 28
Most frequent other events
EventFasinumab-matching Placebo Q4W/Q8WFasinumab 1mg SC Q8WFasinumab 1mg SC Q4WFasinumab 3mg SC Q4WFasinumab 6mg SC Q8WFasinumab 6mg SC Q4WFasinumab 9mg SC Q4W
ArthralgiaMusculoskeletal and connective tissue disorders413/1257347/966350/97469/214710/167753/11645/115
HeadacheNervous system disorders395/1257370/966418/97476/214554/167734/11630/115
NasopharyngitisInfections and infestations184/1257189/966211/97443/214224/167712/11618/115
Back painMusculoskeletal and connective tissue disorders204/1257207/966185/97430/214283/167714/11613/115
Pain in extremityMusculoskeletal and connective tissue disorders113/1257114/966124/97416/214151/167720/11612/115
OsteoarthritisMusculoskeletal and connective tissue disorders74/125760/96675/97430/214116/16777/1166/115
Upper respiratory tract infectionInfections and infestations142/125782/96689/97417/214220/167715/11610/115
Urinary tract infectionInfections and infestations126/125784/966125/97421/214160/16779/1166/115
ToothacheGastrointestinal disorders110/125791/966118/97411/214118/16775/1163/115
DiarrhoeaGastrointestinal disorders58/125755/96646/97410/21481/167713/1164/115

Baseline characteristics

The full analysis set for the evaluation of long-term safety (FAS-LTS) included all randomized participants in the study.

Age, Continuous
Age, Continuous(Years)Fasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4WTotal
Mean63.7 ± 9.2465.0 ± 9.2465.1 ± 8.5765.3 ± 9.1962.9 ± 9.6162.4 ± 8.3863.4 ± 9.8964.0 ± 9.28
Sex: Female, Male
Sex: Female, Male(Participants)Fasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4WTotal
Female913723705149123783763886
Male3472482706544333391445
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Fasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4WTotal
Hispanic or Latino117177182612488622
Not Hispanic or Latino113979178720715471081074686
Unknown or Not Reported436190023
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Fasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4WTotal
American Indian or Alaska Native1950530801131
Asian25790520093
Native Hawaiian or Other Pacific Islander10000102
Black or African American1566466162131512542
White9967597381901352991024236
More than one race00000000
Unknown or Not Reported639110985510327
Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Subscale Score
Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Subscale Score(Score on a Scale)Fasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4WTotal
Mean6.6 ± 1.556.70 ± 1.446.6 ± 1.496.5 ± 1.476.6 ± 1.41——6.6 ± 1.47
WOMAC Physical Function Subscale Score
WOMAC Physical Function Subscale Score(Score on a Scale)Fasinumab-matching Placebo Q4W/Q8WFasinumab 1 mg SC Q8WFasinumab 1 mg SC Q4WFasinumab 3 mg SC Q4WFasinumab 6 mg SC Q8WFasinumab 6 mg SC Q4WFasinumab 9 mg SC Q4WTotal
Mean6.47 ± 1.5836.56 ± 1.6316.41 ± 1.4956.27 ± 1.6996.38 ± 1.598——6.42 ± 1.602
08

Study locations

150 sites
  • Regeneron Investigational Site
    Birmingham, Alabama 35211, United States
  • Regeneron Investigational Site #1
    Chandler, Arizona 85224, United States
  • Regeneron Investigational Site #2
    Chandler, Arizona 85224, United States
  • Regeneron Investigational Site
    Glendale, Arizona 85308, United States
  • Regeneron Investigational Site
    Mesa, Arizona 85213, United States
  • Regeneron Investigational Site (4 locations)
    Phoenix, Arizona 85018, United States
  • Regeneron Investigational Site
    Tempe, Arizona 85224, United States
  • Regeneron Investigational Site (2 locations)
    Tucson, Arizona 85712, United States
  • Regeneron Investigational Site
    Little Rock, Arkansas 72205, United States
  • Regeneron Investigational Site
    Beverly Hills, California 90211, United States
  • Regeneron Investigational Site
    Carlsbad, California 92008, United States
  • Regeneron Investigational Site
    San Diego, California 92103, United States
  • Regeneron Investigational Site
    San Marcos, California 92078, United States
  • Regeneron Investigational Site
    Vista, California 92083, United States
  • Regeneron Investigational Site
    Aurora, Colorado 80014, United States
  • Regeneron Investigational Site
    Colorado Springs, Colorado 80909, United States
  • Regeneron Investigational Site
    Golden, Colorado 80401, United States
  • Regeneron Investigational Site
    Littleton, Colorado 80127, United States
  • Regeneron Investigational Site
    Clearwater, Florida 33765, United States
  • Regeneron Investigational Site
    Orlando, Florida 32801, United States
  • Regeneron Investigational Site
    Pinellas Park, Florida 33781, United States
  • Regeneron Investigational Site
    Atlanta, Georgia 30328, United States
  • Regeneron Investigational Site (3 locations)
    Chicago, Illinois 60602, United States
  • Regeneron Investigational Site
    Evansville, Illinois 47714, United States
  • Regeneron Investigational Site
    Kansas City, Kansas 64114, United States
  • Regeneron Investigational Site
    Frederick, Maryland 21702, United States
  • Regeneron Investigational Site
    Worcester, Massachusetts 01605, United States
  • Regeneron Investigational Site
    Richfield, Minnesota 55423, United States
  • Regeneron Investigational Site #1
    Saint Louis, Missouri 63141, United States
  • Regeneron Investigational Site #2
    Saint Louis, Missouri 63141, United States
  • Regeneron Investigational Site
    Elkhorn, Nebraska 68022, United States
  • Regeneron Investigational Site
    Fremont, Nebraska 68025, United States
  • Regeneron Investigational Site
    Omaha, Nebraska 68144, United States
  • Regeneron Investigational Site
    Las Vegas, Nevada 89128, United States
  • Regeneron Investigational Site
    Jamaica, New York 11432, United States
  • Regeneron Investigational Site
    New York, New York 10036, United States
  • Regeneron Investigational Site
    High Point, North Carolina 27262, United States
  • Regeneron Investigational Site
    Akron, Ohio 44311, United States
  • Regeneron Investigational Site
    Cincinnati, Ohio 45219, United States
  • Regeneron Investigational Site
    Columbus, Ohio 43212, United States
  • Regeneron Investigational Site
    Oklahoma City, Oklahoma 73119, United States
  • Regeneron Investigational Site
    Duncansville, Pennsylvania 16635, United States
  • Regeneron Investigational Site
    Anderson, South Carolina 29621, United States
  • Regeneron Investigational Site
    Greer, South Carolina 29651, United States
  • Regeneron Investigational Site #1
    Dallas, Texas 75234, United States
  • Regeneron Investigational Site #2
    Dallas, Texas 75234, United States
  • Regeneron Investigational Site
    Houston, Texas 77008, United States
  • Regeneron Investigational Site
    Lubbock, Texas 79424, United States
  • Regeneron Investigational Site
    Plano, Texas 75093, United States
  • Regeneron Investigational Site
    San Antonio, Texas 78229, United States
  • Regeneron Investigational Site
    Burgas, 8000, Bulgaria
  • Regeneron Investigational Site #1
    Plovdiv, 4000, Bulgaria
  • Regeneron Investigational Site #2
    Plovdiv, 4002, Bulgaria
  • Regeneron Investigational Site #3
    Plovdiv, 4004, Bulgaria
  • Regeneron Investigational Site #1
    Sofia, 1000, Bulgaria
  • Regeneron Investigational Site #2
    Sofia, 1612, Bulgaria
  • Regeneron Investigational Site
    Stara Zagora, 6000, Bulgaria
  • Regeneron Investigational Site
    Santiago, 8331143, Chile
  • Regeneron Investigational Site
    Bogota, 110221, Colombia
  • Regeneron Investigational Site
    Medellin, 50003, Colombia
  • Regeneron Investigational Site
    Aalborg, 9000, Denmark
  • Regeneron Investigational Site
    Ballerup, 2750, Denmark
  • Regeneron Investigational Site
    Vejle, DK 7100, Denmark
  • Regeneron Investigational Site
    Paide, 72713, Estonia
  • Regeneron Investigational Site
    Tallinn, 10128, Estonia
  • Regeneron Investigational Site
    Leipzig, Sachsen 04103, Germany
  • Regeneron Investigational Site
    Berlin, 1267, Germany
  • Regeneron Investigational Sites
    Bochum, 44787, Germany
  • Regeneron Investigational Site
    Frankfurt, 60313, Germany
  • Regeneron Investigational Site
    Magdeburg, 39120, Germany
  • Regeneron Investigational Site
    Central, Hong Kong
  • Regeneron Investigational Site
    Budapest, 1036, Hungary
  • Regeneron Investigational Site
    Debrecen, 4025, Hungary
  • Regeneron Investigational Site
    Gyula, 5700, Hungary
  • Regeneron Investigational Site
    Hatvan, 3000, Hungary
  • Regeneron Investigational Site
    Zalaegerszeg, 8900, Hungary
  • Regeneron Investigational Site
    Firenze, 50139, Italy
  • Regeneron Investigational Site
    Naples, 80138, Italy
  • Regeneron Investigational Site
    Alytus, LT-62114, Lithuania
  • Regeneron Investigational Site
    Kaunas, 48259, Lithuania
  • Regeneron Investigational Site
    Vilnius, 10323, Lithuania
  • Regeneron Investigational Site
    Šiauliai, LT-76231, Lithuania
  • Regeneron Investigational Site
    Mexicali, Baja Californina 21100, Mexico
  • Regeneron Investigational Site
    Cuauhtemoc, Ciudad De Mexico 06700, Mexico
  • Regeneron Investigational Site
    Cuauhtémoc, Ciudad De Mexico 06700, Mexico
  • Regeneron Investigational Site
    Distrito Federal, DF 03100, Mexico
  • Regeneron Investigational Site
    Mexico, Distrito Federal 11850, Mexico
  • Regeneron Investigational Site
    Guadalajara, Jalisco 44160, Mexico
  • Regeneron Investigational Site
    Guadalajara, Jalisco 44660, Mexico
  • Regeneron Investigational Site
    Cuauhtemoc, Mexico City 06100, Mexico
  • Regeneron Investigational Site
    Cuernavaca, Morelos 62290, Mexico
  • Regeneron Investigational Site
    Culiacan, Sinaloa 80000, Mexico
  • Regeneron Investigational Site
    Merida, Yucatan 97000, Mexico
  • Regeneron Investigational Site
    Merida, Yucatan C.P. 97070, Mexico
  • Regeneron Investigational Site
    Lima, 27, Peru
  • Regeneron Investigational Site
    Gdańsk, 80-382, Poland
  • Regeneron Investigational Site
    Gdynia, 81-537, Poland
  • Regeneron Investigational Site
    Katowice, 40-040, Poland
  • Regeneron Investigational Site
    Kraków, 31-501, Poland
  • Regeneron Investigational Site
    Poznań, 60-702, Poland

Showing the first 100 of 150 sites across 21 countries.

09

References and documents

Study documents

  • Study protocol · Apr 22, 2019
  • Statistical analysis plan · Apr 13, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 13, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02683239
Lead sponsor
Regeneron Pharmaceuticals
Collaborators
Teva Pharmaceutical Industries, Ltd.
Responsible party
Sponsor
First posted
Feb 17, 2016
Start date
Feb 17, 2016
Primary completion
Dec 1, 2020
Completion
Jun 15, 2021
Results posted
Oct 13, 2023
Last update
Oct 13, 2023

Study contacts

Clinical Trial Management
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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