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:
Condition or disease | Intervention/treatment | Phase |
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Osteoarthritis of the Knee Pain | Drug: REGN5069 Drug: Matching Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 259 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | May 21, 2019 |
Actual Primary Completion Date : | May 1, 2020 |
Actual Study Completion Date : | October 29, 2020 |
Arm | Intervention/treatment |
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Experimental: REGN5069 Low Dose
Randomized in a 1:1:1 ratio
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Drug: REGN5069
Intravenous (IV) Dose every 4 weeks (Q4W)
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Experimental: REGN5069 High Dose
Randomized in a 1:1:1 ratio
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Drug: REGN5069
Intravenous (IV) Dose every 4 weeks (Q4W)
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Experimental: Matching Placebo
Randomized in a 1:1:1 ratio
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Drug: Matching Placebo
Intravenous (IV) Dose every 4 weeks (QW4)
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Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined inclusion/exclusion criteria apply.
United States, Florida | |
Regeneron Study Site | |
DeLand, Florida, United States, 32720 | |
Regeneron Study Site | |
Jupiter, Florida, United States, 33458 | |
Regeneron Study Site | |
Miami, Florida, United States, 33143 | |
United States, South Carolina | |
Regeneron Study Site | |
Charleston, South Carolina, United States, 29406 | |
Georgia | |
Regeneron Study Site | |
Tbilisi, Georgia, 112 | |
Moldova, Republic of | |
Regeneron Study Site | |
Chisinau, Moldova, Republic of, MD2025 | |
Poland | |
Regeneron Study Site | |
Zgierz, Lodzkie, Poland, 95-100 | |
Regeneron Study Site | |
Lublin, Lubelskie, Poland, 20-412 | |
Regeneron Study Site | |
Zamosc, Lubelskie, Poland, 22-400 | |
Regeneron Study Site | |
Warsaw, Mazowieckie, Poland, 02 - 777 | |
Regeneron Study Site | |
Bialystok, Podlaskie, Poland, 15-879 | |
Ukraine | |
Regeneron Study Site | |
Kyiv, Ukraine, 1135 |
Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
Tracking Information | |||||||||||||||||||||
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First Submitted Date ICMJE | May 16, 2019 | ||||||||||||||||||||
First Posted Date ICMJE | May 20, 2019 | ||||||||||||||||||||
Last Update Posted Date | November 23, 2020 | ||||||||||||||||||||
Actual Study Start Date ICMJE | May 21, 2019 | ||||||||||||||||||||
Actual Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||||||
Current Primary Outcome Measures ICMJE |
Change from baseline to week 12 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score in patients treated with REGN5069 compared to patients treated with placebo [ Time Frame: Baseline to Week 12 ] The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||||||
Change History | |||||||||||||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||||
Descriptive Information | |||||||||||||||||||||
Brief Title ICMJE | A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee | ||||||||||||||||||||
Official Title ICMJE | 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 | ||||||||||||||||||||
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:
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Detailed Description | Not Provided | ||||||||||||||||||||
Study Type ICMJE | Interventional | ||||||||||||||||||||
Study Phase ICMJE | Phase 2 | ||||||||||||||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||||||||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||||||||||||||
Recruitment Status ICMJE | Terminated | ||||||||||||||||||||
Actual Enrollment ICMJE |
259 | ||||||||||||||||||||
Original Estimated Enrollment ICMJE |
240 | ||||||||||||||||||||
Actual Study Completion Date ICMJE | October 29, 2020 | ||||||||||||||||||||
Actual Primary Completion Date | May 1, 2020 (Final data collection date for primary outcome measure) | ||||||||||||||||||||
Eligibility Criteria ICMJE |
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined inclusion/exclusion criteria apply. |
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years and older (Adult, Older Adult) | ||||||||||||||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||
Listed Location Countries ICMJE | Georgia, Moldova, Republic of, Poland, Ukraine, United States | ||||||||||||||||||||
Removed Location Countries | |||||||||||||||||||||
Administrative Information | |||||||||||||||||||||
NCT Number ICMJE | NCT03956550 | ||||||||||||||||||||
Other Study ID Numbers ICMJE | R5069-OA-1849 | ||||||||||||||||||||
Has Data Monitoring Committee | Yes | ||||||||||||||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Regeneron Pharmaceuticals | ||||||||||||||||||||
Study Sponsor ICMJE | Regeneron Pharmaceuticals | ||||||||||||||||||||
Collaborators ICMJE | Not Provided | ||||||||||||||||||||
Investigators ICMJE |
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PRS Account | Regeneron Pharmaceuticals | ||||||||||||||||||||
Verification Date | November 2020 | ||||||||||||||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |