A study to determine the safety and the efficacy of fasinumab compared to placebo and naproxen for treatment of adults with pain from osteoarthritis of the knee or hip

Phase 1

Conditions: Pain due to osteoarthritis of the knee or hip
MedDRA version: 21.1Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859
MedDRA version: 21.1Level: LLTClassification code 10020108Term: Hips osteoarthritisSystem Organ Class: 100000004859
Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Registration Number: EUCTR2016-005020-29-BG

Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 2845

Inclusion Criteria

Key Inclusion Criteria for Year 1:
1. Male and female patients, at least 18 years of age, at screening
2. A 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 at both the
screening and randomization visits
4.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])
5. A history of at least 12 weeks of analgesics use for pain due to OA of
the knee or hip, as defined by
a.Inadequate pain relief from acetaminophen/paracetamol AND
b.Intolerance to or inadequate pain relief from opioid or tramadol
therapy, unwillingness to take opioid or tramadol therapy for a medically
acceptable reason, or lack of access to an opioid or to tramadol
6. Currently using a stable dose of NSAID, defined as using oral NSAIDs
at regularly prescribed doses for approximately 4 days per week over
the last 4 weeks (patients who are screen failures prior to the
randomization visit but who met the NSAID use criterion at screening
would still meet this criterion if they are eligible for rescreening)
7. Willing to discontinue glucosamine sulfate and chondroitin sulfate
treatments during the initial 16 weeks of treatment
8. Stable treatment with glucosamine sulfate and chondroitin sulfate
treatments must be stopped during the pre-randomization period
9. Consent to allow all radiographs and medical/surgical/hospitalization
records of care received elsewhere prior to and during the study period
to be shared with the investigator
10. Willing to maintain current activity and exercise levels throughout
the study
11. Willing and able to comply with clinic visits and study-related
procedures and willing to provide follow-up information related to any
JR surgery that occurs within the period of time covered by their
intended participation in the study
12. Able to understand and complete study-related questionnaires
Key Inclusion Criteria for Year 2
Note: Any Year 1 patient attending their week 52 visit on or after 26
March 2020 will no longer have the option to enroll into Year 2.
1. Completed the treatment period of Year 1
2. Did not permanently discontinue study drug during Year 1
3. Received no less than 10 of the 13 planned doses of SC study drug
during the treatment period of Year 1
4. Provide informed consent for Year 2
5. Willing to continue to maintain current activity and exercise levels
throughout Year 2
6. Willing and able to comply with clinic visits and study-related
procedures and willing to provide follow-up information related to any
JR surgery that occurs within the period of
time covered by their intended participation in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1645
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1200

Exclusion Criteria

Key Exclusion Criteria for Year 1:
1. Non-compliance with the NRS recording during the pre-randomization
period (4 or more
consecutive missed diary entries)
2. History or presence at the screening visit of non-OA inflammatory
joint disease (eg,
rheumatoid arthritis, lupus erythematosus, psoriatic arthritis, pseudogout,
gout,
spondyloarthropathy,
polymyalgia rheumatica, joint infections within the
past
5 years),
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 (osteonecrosis,
subchondral
insufficiency fracture, rapidly progressive OA type 1 or type
2),
stress fracture, recent stress fracture, neuropathic joint arthropathy,
hip
dislocation (prosthetic hip dislocation is eligible), knee dislocation
(patella
dislocation is eligible), 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 fractures during the screening
period
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 visit
6. Patient is not a candidate for 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 one eventually became
necessary
8. History or presence at the screening visit of autonomic neuropathy,
diabetic neuropathy, or other peripheral neuropathy, including reflex
sympathetic dystrophy
9. History or diagnosis of chronic autonomic failure syndrome including
pure autonomic failure, multiple system atrophy (Shy-Drager syndrome)
10.History of naproxen intolerance, or existence of a medical condition
that is high risk for naproxen-associated complications (eg, high risk of
gastrointestinal bleed, previous ulcer, condition requiring use of anticoagulants
or anti-platelet therapy, or acute coronary syndrome)
11.
Known allergy or sensitivity to doxycycline or related compounds, or
monoclonal
antibodies
12.
Poorly controlled diabetes (defined as any single value of
hemoglobin
A1c [HbA1c] >9.0%) at the screening visit
13.
Known history of human immunodeficiency virus infection
14.
Known history of ocular herpes simplex virus, herpes simplex virus
pneumonia,
or herpes
simplex
virus encephalitis
15.
History of sickle cell disease, including sickle cell anemia and ßthalassemia
16.
Confirmed elevated screening alanine aminotransferase (ALT) or
aspartate
aminotransferase (AST) =2.5 times the upper limit of normal
(ULN)
17.
Resting heart rate of <50 beats per minute (bpm) or >100 bpm (by
vital
sign assessment
or
as captured during electrocardiogram [ECG] assessment) at the
screening
or randomization visits
18.
History or presence of 2nd or 3rd degree heart block, 1st degree
heart
block with abnormal QRS complex, or bifascicular block by ECG
assessment
at the screening visit
19.
History or presence of orthostatic hypotension, as defined in Section
8.2.3.4,
at the screening, pre-randomization, or randomization visits
20.History
of poorly controlled hypertension
21.Congestive
heart failure with NY Heart Classification of stage III or
IV

22.History
of peripheral vascular disease, transient ischemic attack,
cerebrovascular
accident, myocardial infarction, unstable angina, or
documented
ath

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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