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Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis (ONWARDS)

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: NCT04864392
Recruitment Status : Recruiting
First Posted : April 28, 2021
Last Update Posted : July 15, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The study will determine the optimal dosing regimen of LNA043 in patients with knee osteoarthritis (OA).

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: LNA043 Dosing Regimen A Drug: LNA043 Dosing Regimen B Drug: LNA043 Dosing Regimen C Drug: LNA043 Dosing Regimen D Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 5-year, Randomized, Double-blind, Placebo-controlled, Multi-center Study Assessing the Efficacy, Safety, and Tolerability of Intra-articular Regimens of LNA043 Versus Placebo in Patients With Symptomatic Knee Osteoarthritis
Actual Study Start Date : May 31, 2021
Estimated Primary Completion Date : November 7, 2024
Estimated Study Completion Date : October 25, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: LNA043 Dosing Regimen A
LNA043 injection to the knee with dosing regimen A
Drug: LNA043 Dosing Regimen A
Injection to the knee

Experimental: LNA043 Dosing Regimen B
LNA04 injection to the knee with dosing regimen B
Drug: LNA043 Dosing Regimen B
Injection to the knee

Experimental: LNA043 Dosing Regimen C
LNA043 injection to the knee with dosing regimen C
Drug: LNA043 Dosing Regimen C
Injection to the knee

Experimental: LNA043 Dosing Regimen D
LNA043 injection to the knee with dosing regimen D
Drug: LNA043 Dosing Regimen D
Injection to the knee

Placebo Comparator: Placebo
Injection to the knee
Drug: Placebo
Injection to the knee




Primary Outcome Measures :
  1. Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging. [ Time Frame: Week 0 to Week 104 ]
    To evaluate cartilage thickness changes


Secondary Outcome Measures :
  1. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index pain scale. The scale (5 questions) ranges from 0 to 50. Higher score indicates a worse outcome. [ Time Frame: Week 0 to Week 104 ]
    To evaluate changes from baseline in OA pain

  2. Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index function scale. The scale (17 questions) ranges from 0 to 170. Higher scores indicates a worse outcome. [ Time Frame: Week 0 to Week 104 ]
    To evaluate changes from baseline in physical function

  3. Change from baseline in the cartilage thickness of the knee as assessed by imaging. [ Time Frame: Week 0 to Week 104 ]
    To evaluate changes from baseline the cartilage structure

  4. Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 40-meter (4×10m) fast-paced walk test [ Time Frame: Week 0 to Week 104 ]
    To evaluate changes from baseline in physical function

  5. Change from baseline in the Osteoarthritis Research Society International physical performance-based assessments 30-second chair stand test [ Time Frame: Week 0 to Week 104 ]
  6. Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 6-minute walking test [ Time Frame: Weeek 0 to Week 104 ]
  7. Proportion of participants demonstrating structural progression [ Time Frame: Week 0 to Week 104 ]
    To evaluate structural progression

  8. Assessing percentage of participants with adverse events and serious adverse events [ Time Frame: Week 0 to Week 104 ]
    To evaluate safety and tolerability of the various LNA043 regimens



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females between 40 and 75 years of age
  • Body mass index (BMI) < 40 kg/m2
  • Diagnosis of primary tibiofemoral knee OA by standard American College of Rheumatology clinical and radiographic criteria
  • and other criteria as specified by the protocol

Exclusion Criteria:

  • Participants with radiographic knee OA K-L grade = 4 on the non-target knee
  • Arthroscopy of the target knee within the 6 months prior to Screening
  • Hemoglobin < 8.5 g/dL (85 g/L) or platelet count < 100,000/μL
  • and other criteria as specified by the protocol

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): NCT04864392


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals +41613241111

Locations
Show Show 99 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04864392    
Other Study ID Numbers: CLNA043A12202
2020-004897-22 ( EudraCT Number )
First Posted: April 28, 2021    Key Record Dates
Last Update Posted: July 15, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
LNA043
knee
arthritis
OA
knees
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases