Overview

Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip

Status:
Completed
Trial end date:
2020-11-09
Target enrollment:
0
Participant gender:
All
Summary
The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: - To evaluate the efficacy of fasinumab compared to non-steroidal anti-inflammatory drugs (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip - To assess the safety and tolerability of fasinumab compared to placebo and compared to NSAIDs, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborator:
Teva Pharmaceutical Industries, Ltd.
Treatments:
Anti-Inflammatory Agents, Non-Steroidal
Celecoxib
Diclofenac
Fasinumab
Criteria
Key Inclusion Criteria (additional criteria may apply at screening):

1. A clinical diagnosis of osteoarthritis (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.

2. Willing to discontinue current pain medications and to adhere to study requirements
for rescue treatments (acetaminophen/paracetamol to be taken as needed with a maximum
daily dose of 2500 mg [countries where 500 mg strength tablets/capsules are available]
or 2600 mg [countries where 325 mg strength tablets/capsules are available])

3. A history of at least 12 weeks of inadequate pain relief or intolerance to analgesics
used for pain due to OA of the knee or hip

4. Currently using a stable dose of NSAID

5. Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during
the 24 weeks of treatment

Key Exclusion Criteria (additional criteria may apply at screening):

1. Non-compliance with the numeric rating scale (NRS) recording during the
pre-randomization period

2. History or presence at the screening visit of non-OA inflammatory joint disease,
Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple
sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal
osteodystrophy

3. History or presence on imaging of arthropathy, hip or knee dislocation, extensive
subchondral cysts, evidence of severe structural damage, bone collapse, or primary
metastatic tumor with the exception of chondromas or pathologic fractures

4. Trauma to the index joint within 3 months prior to the screening visit

5. Signs or symptoms of carpal tunnel syndrome within 6 months of screening

6. Patient is not a candidate for magnetic resonance imaging (MRI)

7. Is scheduled for a JR surgery to be performed during the study period or who would be
unwilling or unable to undergo JR surgery if needed

8. History or presence at the screening visit of autonomic or diabetic neuropathy, or
other peripheral neuropathy, including reflex sympathetic dystrophy

9. Evidence of autonomic neuropathy as defined in the schedule of assessments (SoAs)

10. History or diagnosis of chronic autonomic failure syndrome including pure autonomic
failure, multiple system atrophy

11. Use of systemic corticosteroids within 30 days prior to the screening visit.
Intra-articular corticosteroids in the index joint within 12 weeks prior to the
screening visit, or to any other joint within 30 days prior to the screening visit

12. Exposure to an anti-NGF antibody prior to the screening visit or known sensitivity or
intolerance to anti-NGF antibodies

13. Women of childbearing potential who are unwilling to practice highly effective
contraception prior to the start of the first treatment, during the study, and for at
least 20 weeks after the last dose