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A Safety and Efficacy Study of Anti-inflammatory (Canakinumab) and Cartilage Stimulating (LNA043) Drugs Injected Into the Knee Joint of Participants With Knee Osteoarthritis (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: NCT04814368
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : June 2, 2022
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The study will establish safety and efficacy of canakinumab and LNA043 in patients with knee osteoarthritis (OA).

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: canakinumab Biological: LNA043 Other: Placebo to canakinumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 138 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Masking only applies to the canakinumab treatment. LNA043 treatment is open label.
Primary Purpose: Treatment
Official Title: A Randomized, Four-arm, Canakinumab Placebo-controlled, Participant, Investigator and Sponsor-blinded Study Investigating the Safety, Tolerability and Efficacy of Intra-articular Canakinumab Followed by Intra-articular LNA043 in Patients With Knee Osteoarthritis
Actual Study Start Date : August 27, 2021
Estimated Primary Completion Date : April 15, 2024
Estimated Study Completion Date : April 15, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Canakinumab

Arm Intervention/treatment
Experimental: LNA043
Placebo to canakinumab + LNA043
Biological: LNA043
intra-articular injection (into the knee)

Other: Placebo to canakinumab
intra-articular injection (into the knee)

Placebo Comparator: Placebo
Placebo to canakinumab
Other: Placebo to canakinumab
intra-articular injection (into the knee)

Experimental: canakinumab + LNA043
canakinumab + LNA043
Biological: canakinumab
intra-articular injection (into the knee)
Other Name: ACZ885

Biological: LNA043
intra-articular injection (into the knee)

Experimental: canakinumab
canakinumab
Biological: canakinumab
intra-articular injection (into the knee)
Other Name: ACZ885




Primary Outcome Measures :
  1. Change in cartilage volume in the index region measured by MRI [ Time Frame: Baseline to Day 197 ]
    Comparing LNA043 with no LNA043 treatment (Placebo) arms.

  2. Change in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain subscale [ Time Frame: Baseline to Day 85 ]

    Comparing canakinumab with no canakinumab treatment (Placebo) arms.

    The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems.



Secondary Outcome Measures :
  1. Anti-LNA043 antibodies in serum [ Time Frame: Day 15, 43, 85, 197 and 365 ]
  2. ANGPTL3 serum concentrations [ Time Frame: Day 1, 15, 43, 85, 197 and 365 ]
  3. ANGPTL3 synovial fluid concentrations [ Time Frame: Day 1, 15, 43 and 71 ]
  4. LNA043 PK profile in serum (Cmax) [ Time Frame: Day 1 and 43 ]
  5. LNA043 PK profile in serum (Tmax) [ Time Frame: Day 1 and 43 ]
  6. LNA043 PK profile in serum (AUC) [ Time Frame: Day 1 and 43 ]
  7. Change in cartilage volume of the index region measured by MRI [ Time Frame: Baseline to Day 197 and 365 ]
  8. Change in cartilage thickness of the index region measured by MRI [ Time Frame: Baseline to Day 197 and 365 ]
  9. Change in synovitis level measured from Ktrans by Dynamic Contrast Enhanced MRI (DCE-MRI) [ Time Frame: Baseline to Day 85 ]
  10. Change in numeric rating scale (NRS) Pain over time [ Time Frame: Baseline to Day 15, 29, 43, 57, 71, 85, 197 and 365 ]
    The Numerical Rating Scale (NRS) Pain is a subjective assessment in which individuals rate their pain on an eleven-point numerical scale. The scale ranges from 0 (no pain) to 10 (worst possible pain).

  11. Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale over time [ Time Frame: Baseline to Day 15, 29, 43, 57, 71, 85, 197 and 365 ]
    The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems.

  12. Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) Function in daily living (ADL) subscale over time [ Time Frame: Baseline to Day 15, 29, 43, 57, 71, 85, 197 and 365 ]
    The KOOS questionnaire is a commonly used instrument to assess the patient's perception about their knee and associated problems. The original KOOS consists of 5 subscales: Pain (9 questions), Symptoms (7 questions), Function in daily living (ADL) (17 questions), Function in sport and recreation (Sport/Rec) (5 questions) and knee related Quality of Life (QoL) (4 questions). On this scale, 100% indicates no problems and 0% indicates extreme problems.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Moderate to severe OA pain (corresponding to NRS Pain ≥5 to ≤9) in the target knee for the majority of days in the last 3 months prior to Screening
  • KOOS pain subscale <60 for the target knee during Screening
  • High sensitivity C-reactive Protein (hsCRP) ≥2 mg/L
  • Radiographic KL grade 2 to 4 knee OA and joint space width (JSW) 2.0-4.0 mm (men) or 1.5-3.5 mm (women) in the medial tibiofemoral compartment (TFC) in the target knee
  • Contrast-enhanced MRI (CE-MRI) diagnosed moderate or severe knee synovitis based on an established synovititis scoring system (moderate score 9-12 or severe score ≥13)

Exclusion Criteria:

  • History of, or planned; knee replacement (partial or total) in either knee; arthroscopy or lavage in either knee within 6 months prior to screening; any other previous surgical intervention in the target knee, or for the contralateral knee within 12 months prior to Screening, including mosaicplasty, microfracture, meniscectomy >50% or osteotomy
  • Moderate to severe pain in the contralateral knee for the majority of days in the last 3 months prior to screening
  • Malalignment >7.5° in the target knee (either varus or valgus)
  • Any diagnosis of systemic inflammatory arthritis or connective tissue disease, including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, gout, Paget's disease, systemic lupus erythematosus) or other systemic condition that might confound assessment of OA (e.g. fibromyalgia)
  • Ipsilateral hip OA or hip prosthesis recently implanted (within 1 year prior to screening) or hip replacement on either side planned within the study period

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): NCT04814368


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

Locations
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United States, Florida
Novartis Investigative Site Recruiting
Clearwater, Florida, United States, 33765
Novartis Investigative Site Recruiting
Sunrise, Florida, United States, 33351
United States, Nevada
Novartis Investigative Site Recruiting
Las Vegas, Nevada, United States, 89119
United States, North Carolina
Novartis Investigative Site Recruiting
Morehead City, North Carolina, United States, 28557
China, Beijing
Novartis Investigative Site Recruiting
Beijing, Beijing, China, 100044
China, Hunan
Novartis Investigative Site Recruiting
Zhuzhou, Hunan, China
China
Novartis Investigative Site Recruiting
Beijing, China, 100044
Czechia
Novartis Investigative Site Recruiting
Pardubice, Czech Republic, Czechia, 530 02
Novartis Investigative Site Recruiting
Praha, Czech Republic, Czechia, 19000
Novartis Investigative Site Recruiting
Kolin, Czechia, 280 02
Novartis Investigative Site Recruiting
Uherske Hradiste, Czechia, 686 01
Germany
Novartis Investigative Site Recruiting
Herne, Germany, 44649
Russian Federation
Novartis Investigative Site Withdrawn
St Petersburg, Russian Federation, 190068
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: NCT04814368    
Other Study ID Numbers: CLNA043A12203
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: June 2, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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

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


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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 ):
canakinumab
LNA043
knee
osteoarthritis
OA
joint pain
cartilage
MRI
DCE-MRI
KOOS
NRS Pain
IPAQ
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs