Study of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip

Phase 2

Completed

• Conditions: Osteoarthritis, Hip; Osteoarthritis, Knee
• Interventions: Drug: REGN475; Drug: Placebo

• Registration Number: NCT02447276
• Lead Sponsor: Regeneron Pharmaceuticals

Brief Summary

The primary objective of this study is to evaluate the effectiveness of REGN475 compared to placebo in participants with pain due to osteoarthritis (OA) of the knee or hip and a history of inadequate joint pain relief or intolerance to current analgesic therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-05-14
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-18
• Primary Completion: 2016-03
• Status Verified: 2016-10
• Study Completion: 2016-11
• Disposition First Submitted: 2017-03-24
• Disposition First Submitted QC: 2017-03-24
• Last Update Submitted: 2017-03-24
• Disposition First Posted: 2017-03-27
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 421

Inclusion Criteria

1. Body mass index ≤39
2. Clinical diagnosis of OA of the knee or hip
3. History of inadequate pain relief or intolerance to analgesics used for OA
4. Moderate to severe pain in the index joint
5. History of regular use of analgesic medications for OA pain
6. Willing to discontinue current non-steroidal anti-inflammatory drug (NSAID) and opioid pain medications

Key

Exclusion Criteria

1. Other diseases that may involve index knee or hip, including inflammatory joint diseases, crystalline disease (gout or pseudogout), endocrinopathies, metabolic joint disease, lupus erythematosus, rheumatoid arthritis, joint infections, neuropathic disorders, avascular necrosis, Paget's disease, renal osteodystrophy or tumors
2. History of osteonecrosis, destructive arthropathy (RPOA), hip dislocation, pathologic fractures, neuropathic joint arthropathy, knee dislocation or hip dislocation
3. Trauma to the index joint in the 30 days before screening
4. Active fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA
5. Prior to the start of the study has received a recommendation for, or is scheduled for joint replacement surgery to be performed during the study period
6. Presence of subchondral insufficiency fracture on screening films or MRI
7. Received an intra-articular injection of hyaluronic acid in the affected index joint within 90 days prior to the screening visit
8. Systemic (ie, oral or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks of the screening visit, or to any other joint within 30 days prior to the screening visit.
9. History of autonomic neuropathy, diabetic neuropathy, or presence of clinically relevant peripheral neuropathy at the time of screening
10. Women of childbearing potential who have a positive pregnancy test result, or who do not have their pregnancy test results at baseline
11. Pregnant or breastfeeding women

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	REGN475	Group B will receive REGN475 dosing regimen 2
Group D	REGN475	Group D will receive REGN475 dosing regimen 4
Group A	REGN475	Group A will receive REGN475 dosing regimen 1
Group C	REGN475	Group C will receive REGN475 dosing regimen 3
Group E	Placebo	Group E will receive matching placebo

Primary Outcome Measures

Name	Time	Method
The primary endpoint in the study is the change from baseline to week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score.	Baseline to week 16

Secondary Outcome Measures

Name	Time	Method
Change from baseline to week 16 in the WOMAC physical function subscale score	Baseline to week 16
Change from baseline to week 16 in the Patient Global Assessment score	Baseline to week 16
Incidence of anti-REGN475 antibody development	Baseline to week 36 (end of study)
Incidence of treatment-emergent adverse events (TEAEs)	Baseline to week 36 (end of study)