A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee

NCT03956550 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: R5069-OA-1849
• Study Type: interventional
• Target: 259
• Locations: 5 countries
• Sites: 12

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

Conditions

Osteoarthritis of the Knee; Pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 12 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

  The WOMAC index is comprised of 24 parameters grouped in 3 subscales (pain-5 questions, physical function -17 questions and stiffness - 2 questions), with 0-10 grading of each question. The scores for each subscale are summed up, divided by number of questions, and each subscale is reported using Numerical Rating Scale score of 0-10. In addition to subscales, a total score is provided as the sum of normalized subscale scores divided by three, and reported using a Numerical Rating Scale score of 0-10. Higher scores indicate worse pain, stiffness and functional limitations.

  Baseline to Week 12

Secondary Outcomes (8)

• Change From Baseline to Week 12 in WOMAC Total Score

  Week 12

• Change From Baseline to Week 12 in WOMAC Physical Function Subscale Score

  Week 12

• Change From Baseline to Week 12 in Patient Global Assessment (PGA) Score

  Week 12

• Change From Baseline to Week 12 in WOMAC Stiffness Subscale Score

  Week 12

• Percentage of Participants With ≥30% Improvement in WOMAC Pain Subscale Score

  Week 12

Study Arms (3)

REGN5069 Low Dose

EXPERIMENTAL

Randomized in a 1:1:1 ratio

Drug: REGN5069

REGN5069 High Dose

EXPERIMENTAL

Randomized in a 1:1:1 ratio

Drug: REGN5069

Matching Placebo

EXPERIMENTAL

Randomized in a 1:1:1 ratio

Drug: Matching Placebo

Interventions

REGN5069 DRUG

Intravenous (IV) Dose every 4 weeks (Q4W)

REGN5069 High Dose; REGN5069 Low Dose

Matching Placebo DRUG

Intravenous (IV) Dose every 4 weeks (QW4)

Matching Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (12)

Regeneron Study Site

DeLand, Florida, 32720, United States

Location

Regeneron Study Site

Jupiter, Florida, 33458, United States

Location

Regeneron Study Site

Miami, Florida, 33143, United States

Location

Regeneron Study Site

Charleston, South Carolina, 29406, United States

Location

Regeneron Study Site

Tbilisi, 112, Georgia

Location

Regeneron Study Site

Chisinau, MD2025, Moldova

Location

Regeneron Study Site

Lublin, Lublin Voivodeship, 20-412, Poland

Location

Regeneron Study Site

Zamość, Lublin Voivodeship, 22-400, Poland

Location

Regeneron Study Site

Warsaw, Masovian Voivodeship, 02 - 777, Poland

Location

Regeneron Study Site

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Regeneron Study Site

Zgierz, Łódź Voivodeship, 95-100, Poland

Location

Regeneron Study Site

Kyiv, 1135, Ukraine

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trials Administrator
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 20, 2019
• Study Start: May 21, 2019
• Primary Completion: May 1, 2020
• Study Completion: October 29, 2020
• Last Updated: July 1, 2021
• Results First Posted: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Individual anonymized participant data will be considered for sharing once the indication has been approved by a regulatory body, if there is legal authority to share the data and there is not a reasonable likelihood of participant re-identification.
• Access Criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, EMA, PMDA, etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

Locations

GE (1); PL (5); US (4); UA (1); MO (1)