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

• Register: ClinicalTrials.gov
• Last refreshed on: 23 October 2023
• Main ID: NCT02683239
• Date of registration: 28/01/2016
• Prospective Registration: Yes
• Primary sponsor: Regeneron Pharmaceuticals
• Public title: Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip FACT LTS & OA
• Scientific title: A Phase 3 Randomized, Double-blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip
• Date of first enrolment: February 17, 2016
• Target sample size: 5331
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT02683239
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Bulgaria, Chile, Colombia, Denmark, Estonia, Germany, Hong Kong, Hungary, Italy, Lithuania, Mexico, Peru, Poland, Romania, Russian Federation, South Africa, Spain, Sweden, Ukraine, United Kingdom, United States

Contacts

• Name: Clinical Trial Management
• Affiliation: Regeneron Pharmaceuticals

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Osteoarthritis of the Knee or Hip

Intervention(s)

Drug: Fasinumab

Drug: Placebo

Primary Outcome(s)

Number of Participants With Adjudicated Arthropathy (AA) Meeting Destructive Arthropathy (DA) Criteria [Time Frame: Baseline up to week 52 and week 72]

Number of Participants With Any Serious TEAE [Time Frame: Baseline up to week 52]

Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values Post-Treatment up to Week 72 [Time Frame: End of treatment up to week 72]

Number of Participants With Any Treatment-Emergent Adverse Event (TEAE) [Time Frame: Baseline up to week 52]

Number of Participants With Any Serious AE up to Week 72 [Time Frame: Baseline up to week 72]

Number of Participants With Any Adverse Event (AE) up to Week 72 [Time Frame: Baseline up to week 72]

Number of Participants With at Least One Peripheral Sensory Event That Required a Neurology Consultation [Time Frame: Baseline up to week 72]

Change From Baseline to Week 16 in WOMAC Physical Function Subscale Score [Time Frame: Baseline to Week 16]

Number of Participants With Adjudicated Arthropathy (AA) [Time Frame: Baseline up to week 52 and week 72]

Number of Participants With Potentially Clinically Significant Abnormal Laboratory Values up to Week 52 [Time Frame: Baseline to week 52]

Number of Participants With Sympathetic Nervous System (SNS) Dysfunction [Time Frame: Baseline up to week 72]

Number of Participants With Anti-drug Antibody (ADA) up to Week 72 [Time Frame: Baseline up to week 72]

Change From Baseline to Week 16 in the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Pain Subscale Score [Time Frame: Baseline to Week 16]

Number of Participants With at Least One All-Cause Joint Replacement (JR) Surgery [Time Frame: Baseline up to weeks 52, 72, and end of study (52 weeks post last dose)]

Secondary Outcome(s)

Number of Participants With =30% Reduction From Baseline to Week 16 in the WOMAC Pain Subscale Score [Time Frame: Baseline to Week 16]

Change From Baseline to Week 16 in Patient Global Assessment (PGA) Score of Osteoarthritis [Time Frame: Baseline to Week 16]

Secondary ID(s)

R475-PN-1523

2015-003783-36

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Teva Pharmaceutical Industries, Ltd.

Results

• Results available: Yes
• Date Posted: 13/10/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02683239