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WithdrawnNCT01239017Updated Mar 18, 2015

A Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee

A Phase 2 interventional study of REGN475 and Placebo in Osteoarthritis, sponsored by Regeneron Pharmaceuticals. Withdrawn. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-03-18.

Sponsored by Regeneron Pharmaceuticals · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
40 Years to 75 Years
Sex
All
01

Study summary

This is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 5 treatment arms (4 active and 1 placebo).

Each patient will receive one SC injection of REGN475 or placebo and 1 IV infusion of either REGN475 or placebo, on day 1 (baseline) In order to preserve the blind, patients receiving REGN475 SC will also receive placebo IV, and patients receiving REGN475 IV will also receive placebo SC.

02

Conditions studied

  • Osteoarthritis
03

In context

Osteoarthritis

4,399 studies on the registry are indexed under Osteoarthritis; 583 are open to participants now.

Browse Osteoarthritis studies →

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 399 studies on the registry; 90 are open to participants now.

Of its 120 completed or terminated interventional studies of FDA-regulated products, 77 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Diagnosis of OA of the knee according to American College of Rheumatology (ACR) criteria, and experiencing moderate to severe pain in the index knee for at least 3 months prior to the screening visit.
  2. Kellgren-Lawrence grade 2-3 radiographic severity of the index knee at or within 6 months prior to Screening.

Exclusion criteria

Exclusion Criteria:

  1. Significant concomitant illness including, but not limited to, cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the patient's participation in the study.
  2. Patients with joint replacement in the affected knee.
  3. Intra-articular injection of corticosteroids or hyaluronic acid in the affected knee within the 3 months prior to the screening visit.
  4. Women who are pregnant or breast-feeding.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Dose 1

    SC REGN475 Dose 1 and IV Placebo

    Biological: REGN475

  • Experimental
    Dose 2

    SC REGN475 Dose 2 and IV Placebo

    Biological: REGN475

  • Experimental
    Dose 3

    SC REGN475 Dose 3 and IV Placebo

    Biological: REGN475

  • Experimental
    Dose 4

    SC Placebo and IV REGN475 Dose 4

    Biological: REGN475

  • Placebo comparator
    Dose 5

    SC Placebo and IV Placebo

    Other: Placebo

Interventions

  • BiologicalREGN475
  • OtherPlacebo
06

What researchers measure

Primary outcomes

  1. The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.

    Time frame: 16 weeks

Secondary outcomes

  1. Time-integrated change from baseline in walking knee pain using the Numeric Rating Scale (NRS).

    Time frame: 8 weeks

  2. Change from baseline in walking knee pain using the Numeric Rating Scale (NRS).

    Time frame: 8 weeks

  3. Time-integrated change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)

    Time frame: 8 weeks

  4. Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)

    Time frame: 8 weeks

  5. Patient assessment of response to treatment over time using the Patient Global Impression of Change.

    Time frame: 16 weeks

  6. Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).

    Time frame: 8 weeks

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01239017
Lead sponsor
Regeneron Pharmaceuticals
Collaborators
Sanofi
First posted
Nov 11, 2010
Last update
Mar 18, 2015

Study contacts

Paul J Tiseo, PhD
study director · Regeneron Pharmaceuticals

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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