Clinical trial NCT03956550: A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee
Official title: A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis of the Knee
Pain
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-05-20
Enrollment: 259
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to evaluate the efficacy of REGN5069 compared to placebo in patients with pain due to radiographically-confirmed OA of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy.

The secondary objectives of the study are:

* To characterize the concentrations of functional REGN5069 in serum over time when patients are treated for up to 12 weeks
* To assess the safety and tolerability of REGN5069 compared with placebo when patients are treated for up to 12 weeks
* To measure levels of anti-drug antibodies (ADAs) against REGN5069 following multiple IV administrations


Eligibility criteria: Key Inclusion Criteria:

* Generally in good health at the screening visit
* Body mass index (BMI) ≤39 kg/m2 at the screening visit
* Clinical diagnosis of OA of the knee on the American College of Rheumatology criteria (Altman, 1986) with radiologic evidence of OA (K-L score ≥2) at the index joint at the screening visit
* Moderate-to-severe pain in the index joint
* A history of inadequate pain relief from or intolerance to analgesics used for OA

Key Exclusion Criteria:

* Diagnosis of systemic diseases that may affect joints
* History or presence of osteonecrosis, destructive arthropathy, neuropathic joint arthropathy, pathologic fractures in any shoulder, hip, or knee joint(s), hip dislocation (prosthetic hip dislocation is eligible), or knee dislocation (patella dislocation is eligible) at the screening visit. Presence of subchondral insufficiency fracture on screening films or MRI as assessed by the central imaging reader.
* Is scheduled for a joint replacement surgery to be performed during the study period
* Received an intra-articular injection of hyaluronic acid in any joint within 90 days prior to the screening visit
* Systemic (ie, IV, oral, or intramuscular) 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 (topical, intranasal, or inhaled corticosteroids are permitted).
* History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy
* Significant concomitant illness including, but not limited to, psychiatric, cardiac, renal, hepatic, neurological, endocrinological, metabolic, or lymphatic disease that, in the opinion of the investigator, would adversely affect the patient's participation in the study
* History of myocardial infarction, acute coronary syndromes, transient ischemic attack, or cerebrovascular accident within 12 months prior to the screening visit

Note: Other protocol defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Change From Baseline to Week 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Change From Baseline to Week 12 in WOMAC Total Score
timeFrame: Week 12
measure: Change From Baseline to Week 12 in WOMAC Physical Function Subscale Score
timeFrame: Week 12
measure: Change From Baseline to Week 12 in Patient Global Assessment (PGA) Score
timeFrame: Week 12
measure: Change From Baseline to Week 12 in WOMAC Stiffness Subscale Score
timeFrame: Week 12
measure: Percentage of Participants With ≥30% Improvement in WOMAC Pain Subscale Score
timeFrame: Week 12
measure: Number of Non-Serious and Serious Treatment-Emergent Adverse Events (TEAEs) Through End of Study
timeFrame: Baseline to Week 36
measure: Number of Imaging Abnormalities Consistent With Adjudicated Arthropathies Through End of Study
timeFrame: Baseline to Week 36
measure: Number of Participants With Presence of Anti-REGN5049 Antibody Development Through End of Study
timeFrame: Baseline to Week 36
Other outcomes:
Locations:
city: DeLand
country: United States
facility: Regeneron Study Site
state: Florida
city: Jupiter
country: United States
facility: Regeneron Study Site
state: Florida
city: Miami
country: United States
facility: Regeneron Study Site
state: Florida
city: Charleston
country: United States
facility: Regeneron Study Site
state: South Carolina
city: Tbilisi
country: Georgia
facility: Regeneron Study Site
city: Chisinau
country: Moldova, Republic of
facility: Regeneron Study Site
city: Zgierz
country: Poland
facility: Regeneron Study Site
state: Lodzkie
city: Lublin
country: Poland
facility: Regeneron Study Site
state: Lubelskie
city: Zamosc
country: Poland
facility: Regeneron Study Site
state: Lubelskie
city: Warsaw
country: Poland
facility: Regeneron Study Site
state: Mazowieckie
city: Bialystok
country: Poland
facility: Regeneron Study Site
state: Podlaskie
city: Kyiv
country: Ukraine
facility: Regeneron Study Site
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: