Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability and Efficacy of Multiple Intra-articular Injections of LRX712 in Patients With Unilateral Knee OA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04097379
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will explore the preliminary efficacy of multiple intra-articular injections of LRX712 by evaluating the ability of the drug to restore structural integrity articular cartilage. Efficacy will be evaluated in face of the systemic safety and local tolerability of the investigational drug.

Condition or disease Intervention/treatment Phase
Osteoarthritis (OA) Drug: LRX712 Drug: Placebo Phase 2

Detailed Description:
The purpose of this study if to evaluate the safety, tolerability and preliminary efficacy of multiple intra-articular injections of LRX712 in the knee when treating patients with unilateral knee osteoarthritis of mild/moderate severity, in order to support the further clinical development. This study will also allow refinement of the systemic and local pharmacokinetics of LRX712 and the exploration of biomarkers of cartilage breakdown and regeneration in OA patients.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Subject and Investigator Blinded Study Investigating the Safety, Tolerability and Efficacy of 8-week Treatment With Intra-articular LRX712 in Patients With Mild/Moderate Unilateral Knee Osteoarthritis.
Estimated Study Start Date : December 9, 2019
Estimated Primary Completion Date : February 5, 2021
Estimated Study Completion Date : February 5, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: LRX712
Randomized in a 1:1 ratio: LRX712 to placebo
Drug: LRX712
LRX712 intra-articular injections

Placebo Comparator: Placebo
Randomized in a 1:1 ratio: LRX712 to placebo
Drug: Placebo
Placebo intra-articular injections




Primary Outcome Measures :
  1. Changes in articular cartilage [23Na] content from baseline compared to placebo at week 28 [ Time Frame: Baseline and Week 28 ]
    Efficacy of multiple intra-articular injections of LRX712 in regenerating cartilage as measured with 7T MRI


Secondary Outcome Measures :
  1. Changes in articular cartilage [23Na] content from baseline compared to placebo at Week 16 [ Time Frame: Baseline and Week 16 ]
    Efficacy of multiple intra-articular injections of LRX712 measured with 7T MRI

  2. Changes from baseline in cartilage morphometrics (volume and thickness) in the medial femoral condyle at Week 16 and 28 [ Time Frame: Baseline, Week 16 and week 28 ]
    Efficacy of multiple intra-articular injections of LRX712 measured with 7T MRI

  3. Time to Reach the Maximum Plasma Concentration (Tmax) [ Time Frame: Pre-dose to 28 weeks ]
    The observed time to reach max (Tmax) plasma concentration following drug administration

  4. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Pre-dose to 28 weeks ]
    The observed maximum (Cmax) plasma concentration following drug administration

  5. Minimum Observed Plasma Concentration (Cmin) [ Time Frame: Pre-dose to 28 weeks ]
    The observed minimum (Cmin) plasma concentration following drug administration

  6. Concentration in synovial fluid [ Time Frame: Day 1; week 4; week 8 ]
    The observed synovial concentration following drug administration



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Written informed consent must be obtained before any assessment is performed.

To be eligible for inclusion in this study patients must meet all of the following criteria:

  • Patient must have a BMI within 18 -32
  • Patient must have symptomatic unilateral knee osteoarthritis
  • Patient must have unilateral knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) as confirmed by radiography
  • Patient must have radiographic confirmation of a joint space width of 2 to 4 mm within the medial tibio-femoral compartment of the affected knee

Exclusion Criteria:

Subjects meeting any of the following criteria are not eligible for inclusion in this study:

  • Patient has a known autoimmune disease, inflammatory arthropathy
  • Patient had partial or complete joint replacement in one or both knees
  • Patient has symptomatic, isolated patello-femoral pain in the index knee as per the Investigator's examination
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
  • Previous use of LRX712 or use of other investigational drugs at the time of enrollment, or within 5 half-lives of enrollment, or within 30 days, whichever is longer; or longer if required by local regulations
  • Patient has malalignment (valgus- or varus-deformity) in the index knee ≥ 5° as per anatomic PA axis measured by weight-bearing short knee radiography
  • History of significant cardiac conduction/electrophysiological disorder, e.g. familial long QT syndrome or known family history of Torsades de Pointes or prolonged QT syndrome or QTcF ≥ 450 msec (Fridericia Correction) for males and ≥ 460 msec for females at screening or baseline (by local ECG reading)

Other protocol-defined inclusion/exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04097379


Contacts
Layout table for location contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
Layout table for location information
Netherlands
Novartis Investigative Site Not yet recruiting
Leiden, Netherlands, 2333 CL
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04097379     History of Changes
Other Study ID Numbers: CLRX712A12201
2019-002963-92 ( EudraCT Number )
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Knee osteoarthritis
Chondroanabolic drug
Magnetic resonance imaging
Patient Reported Outcomes
Biosensors
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases