OsteoarthritisPhase 2NCT03275064

Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.

A Phase 2 study testing LNA043 in people with Osteoarthritis, run by Novartis Pharmaceuticals at 19 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this two-part study is to assess the efficacy, safety and tolerability of multiple intra-articular (i.a.) injections of LNA043, in regenerating the articular surface in patients with cartilage lesions of the knee (Part A) and knee osteoarthritis (Part B). Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Osteoarthritis
What is being tested?: LNA043
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 142 participants
Where: 19 sitesin 3 countries
Study dates: 12 Sep 2017to 6 Sep 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient was ≥18 and ≤55 years old at time of screening.
Patient had a body mass index (BMI) <30 kg/m2 at screening,
Patient had a symptomatic, single, articular cartilage defect of one knee, grade II or IIIA according to the ICRS classification, localized to either the femoral condyles/femoral trochlea or to the patella, based on MRI or arthroscopy performed within 9 months before screening visit and confirmed by screening 3T MRI.
Patient had an onset of pain and impairment of function between two (2) months and two (2) years before screening.
Patient had a grade 2 or 3 OA of the knee with Joint Space Width (JSW) 2-4 mm evaluated with X-Ray at screening
Patient was ≥18 and ≤75 years old at time of screening.

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Patient had a body mass index (BMI) ≤ 35 kg/m2 at screening
Diagnosis of femorotibial osteoarthritis (OA) in the target knee by standard American College of Rheumatology (ACR) criteria at study start (clinical AND radiographic criteria)
Patient must have had symptomatic disease predominantly in one (the index) knee, with minimal or no symptoms in the contralateral knee. Symptomatic disease is defined as having pain in the knee more than 50% of the days during the last 3 months from screening.
Patient had a K\&L grade 2 or 3 OA of the knee with JSW 2.00-4.00 mm (X=0.225) fixed position evaluated with X-Ray by the Central Reader at screening.

Who cannot join

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 15 days after stopping of investigational drug.
Patient had surgical treatment of the target knee using mosaicplasty, microfracture, meniscectomy >50% (Note: prior diagnostic arthroscopy with debridement and lavage, <50% meniscectomy, lateral release, patellar realignment, medial patellofemoral ligament reconstruction are acceptable if performed at least 2 months prior to screening; anteriorcruciate ligament reconstrucion is acceptable if performed 12 months prior to screening, or less if restoration of joint function is evident, and agreed by the sponsor).
Patient had an unstable target knee joint or insufficiently reconstructed ligaments based on medical history and physical examination by the investigator.
Prohibited medication updated with reference to dosing (formerly screening).
Regular smokers (> 5 cigarettes/day). Urine cotinine levels will be measured during screening for all patients. Regular smokers will be defined as any patient who reports tobacco use of > 5 cigarettes/day and/or who has a urine cotinine ≥ 500 ng/mL.
Patient had radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade ≥2 based on X-ray evaluation performed within 9 months from screening.

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Patient had patellofemoral dysplasia Dejour Grade B-D based on X-ray evaluation performed within 9 months from screening
Patient had malalignment (valgus- or varus-deformity) in the target knee ≥ 5° based on X-ray evaluation performed within 9 months from screening. In suspected cases, the mechanical axis must be established radiographically through complete leg imaging during standing and in postero-anterior (PA) projection.
Regular smokers (> 10 cigarettes/day).
Clinical signs of inflammation (i.e., redness) in the target knee.
History of knee replacement (unilateral or total) in either knee.
Presence of severe hip OA conditioning lower limb function according to PI's evaluation.
Nephrotic syndrome and/or significant proteinuria
History of coagulopathy or medical condition requiring anticoagulation which would preclude knee injection
Patient had malalignment (valgus- or varus-deformity) in the target knee ≥ 7.5° based on X-ray evaluation. In suspected cases, the mechanical axis must be established radiographically through complete leg imaging during standing and in postero-anterior (PA) projection.

Trial locations and contacts

19 sites in 3 countries.

Country

City, postcode or hospital

19 sites in 3 countries

United States11 sites

St Lukes Intermountain Research Center
Boise, Idaho, 83702
Midwest Orthopedics At Rush
Chicago, Illinois, 60612
Scott A Hacker MD Medical Group d b a Horizon Clinical Res
La Mesa, California, 91942
LV Research
Las Vegas, Nevada, 89119
Panax Clinical Research
Miami Lakes, Florida, 33014
Temple University
Philadelphia, Pennsylvania, 19140
Arizona Research
Phoenix, Arizona, 85053
Northern California Research
Sacramento, California, 95821
Sundance Clinical Research LLC
St Louis, Missouri, 63141
Precision Clinical Research LLC
Sunrise, Florida, 33351
Clinical Research of West Florida Inc
Tampa, Florida, 33606

Other trials in United States

Czechia6 sites

Novartis Investigative Site
Brno, Czech Republic, 66250
Novartis Investigative Site
Kladno, 272 59
Novartis Investigative Site
Kolín, 280 02
Novartis Investigative Site
Mladá Boleslav, Czech Republic, 29301
Novartis Investigative Site
Pardubice, 53002
Novartis Investigative Site
Prague, 190 00

Other trials in Czechia

Denmark2 sites

Novartis Investigative Site
Aarhus N, 8200
Novartis Investigative Site
Hvidovre, 2650

Other trials in Denmark

About this study

Official title: A Two-part, Randomized, Placebo-controlled, Patient and Investigator Blinded, Study Investigating the Safety, Tolerability and Preliminary Efficacy of Intra-articular LNA043 Injections in Regenerating the Articular Cartilage of the Knee in Patients With Articular Cartilage Lesions (Part A) and in Patients With Knee Osteoarthritis (Part B).

Read the detailed description

There was a 30 day screening period for both Part A and Part B. In Part A, participants were randomized to 3:1 ratio and received an injection of LNA043 (20 mg in 3 ml) or matching placebo (3 ml) on Days 1, 8,15 and 22 and were monitored in clinic for 3 hours after each injection followed by telephone calls 48 hours after injection. Participants returned to the clinic on Days 50, 106, 190 and 365 for follow up visits. MRIs, safety assessments and pharmacokinetics were assessed at selected clinic visits.

In Part B, this study aimed at further evaluating the cartilage anabolic activity of LNA043 in a more severe knee OA population, and to explore the safety and efficacy of a higher dose.

In Part B, participants were randomized to LNA043 20 mg, LNA043 40 mg or matching placebo according in a 1:1:1 ratio. Injections were given in clinic on Days 1, 29, 57 and 85 and participants were monitored in clinic for 3 hours after each injection followed by telephone calls 48 hours after injection. Participants returned to the clinic on Days 113,197 and 365 (end of study) for follow up visits. MRIs, safety assessments and pharmacokinetics were assessed at selected clinic visits.

Conditions: Osteoarthritis
Being tested: LNA043, Placebo
Keywords: Articular cartilage, partial thickness cartilage lesion, knee cartilage, regeneration, osteoarthritis, adult
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LNA043Biological
LNA043 intra-articular injection
PlaceboOther
Placebo intra-articular injection

Study groups in NCT03275064
Study group	Role	What they receive
LNA043 40 mg Part B	Experimental	LNA043 40 mg Part B Receives: Biological: LNA043
LNA043 20 mg Part B	Experimental	LNA043 20 mg Part B Receives: Biological: LNA043
LNA043 20 mg Part A	Experimental	LNA043 20 mg Part A Receives: Biological: LNA043
Placebo Part A	Placebo comparator	Placebo Part A Receives: Other: Placebo
Placebo Part B	Placebo comparator	Placebo Part B Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Articular Cartilage Collagen Organization in the Overall Cartilage (Femoral and Patellar Lesions) - Part A
Collagen fibril organization in articular cartilage evaluated by Magnetic Resonance Imaging (MRI) from the cartilage mean T2 relaxation time (with lower values indicative of higher quality). The area of interest is the focal cartilage lesion.
Measured: Baseline up to Week 16, Week 28
Change From Baseline in Articular Cartilage Collagen Organization in the Deep Cartilage Layer (Femoral and Patellar Lesions) - Part A
Collagen fibril organization in articular cartilage evaluated by MRI from the cartilage mean T2 relaxation time (with lower values indicative of higher quality). The area of interest is the focal cartilage lesion.
Measured: Baseline up to Week 16, Week 28
Change From Baseline in Articular Cartilage Collagen Organization in the Superficial Cartilage Layer (Femoral and Patellar Lesions) - Part A
Collagen fibril organization in articular cartilage evaluated by MRI from the cartilage mean T2 relaxation time (with lower values indicative of higher quality).The area of interest is the focal cartilage lesion.
Measured: Baseline up to Week 16, Week 28
Change From Baseline of LNA043 to Placebo in Cartilage Volume in the Femoral Medial Index Region (mm3) - Part B
MRI based quantitative assessment using an automated segmentation algorithm
Measured: Baseline, Week 29, Week 53
Change From Baseline of LNA043 to Placebo in Cartilage Thickness in the Femoral Medial Index Region (mm) - Part B
MRI based quantitative assessment using an automated segmentation algorithm.
Measured: Baseline, Week 29, Week 53
Overview of Number of Participants With Adverse Events and Serious Adverse Events for Part A and Part B
Treatment emergent other and serious adverse events (TEAE and TESAE) period:
Part A: Baseline up to Day 50 (included 30 day safety follow-up Part B: Baseline up to Day 113 (included 30 day safety follow-up)
Long term Follow-UP period:
Part A: Day 51 to Day 365 Part B: Day 114 to Day 365
Measured: Baseline up to end of post treatment follow-up

Secondary outcomes (14)

Change From Baseline of LNA043 to Placebo in Cartilage Defect Volume (mm^3) for Both Groups of Patients (Femoral and Patellar Lesions) - Part A
Cartilage volume data were generated from the manual segmentation of the cartilage defect that was identified in MR images.
Measured: Baseline up to Week 16, Week 28
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Overall Part B
Collagen fibril organisation in articular cartilage evaluated by MRI from the cartilage mean T2 relaxation time (with lower values indicative of higher quality). The area of interest is the femoral medial index region comprising the anterior, central and posterior aspects of the femoral condyle.
Measured: Baseline, Week 29, Week 53
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Deep Part B
Collagen fibril organisation in articular cartilage evaluated by MRI from the cartilage mean T2 relaxation time (with lower values indicative of higher quality). The area of interest is the femoral medial index region comprising the anterior, central and posterior aspects of the femoral condyle.
Measured: Baseline, Week 29, Week 53
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Superficial Part B
Collagen fibril organisation in articular cartilage evaluated by MRI from the cartilage mean T2 relaxation time (with lower values indicative of higher quality). The area of interest is the femoral medial index region comprising the anterior, central and posterior aspects of the femoral condyle.
Measured: Baseline, Week 29, Week 53
Incidence of Immunogenicity (IG) Part A
A validated ligand binding assay were used for the detection of anti-LNA043 antibodies, and cross-reactivity to ANGPTL3 and ANGPTL4.
Measured: Week 1,3,8,16,28
Incidence of Immunogenicity (IG) Part B
A validated ligand binding assay were used for the detection of anti-LNA043 antibodies, and cross-reactivity to ANGPTL3 and ANGPTL4.
Measured: Week 1,5,9,13,17,29,53
Serum Concentrations of LNA043 - Part A
Concentrations for LNA043 were determined by a validated LC-MS/MS method; the anticipated LLOQ was 10ng/mL in serum. Concentrations below the LLOQ were reported as "zero"
Measured: Week 1: 0 (pre-dose), 0.25 hours, 1, 2 hours post dose; Weeks 2, 3, 4: 0 hour (pre dose), 1 hour post dose
Serum Concentrations of ANGPTL3 - Part A
Validated bioanalytical assays were used to determine ANGPTL3 in serum with an LLOQ of 2.13 ng/mL. Concentrations below the LLOQ were reported as "zero"
Measured: Week 1: 0 (pre-dose), 0.25 hours, 1, 2 hours post dose; Weeks 2, 3, 4: 0 hour (pre dose), 1 hour post dose
Synovial Fluid Concentrations of LNA043 - Part A
Concentrations for LNA043 were determined by a validated LC-MS/MS method; the anticipated LLOQ was 10ng/mL in synovial fluid. Concentrations below the LLOQ were reported as "zero".
Measured: Weeks 1,2,3,4: 0 hour (pre-dose)
Synovial Fluid Concentrations of ANGPTL3 - Part A
Validated bioanalytical assays were used to determine ANGPTL3 in synovial fluid with an LLOQ of 2.74 ng/mL. Concentrations below the LLOQ were reported as "zero".
Measured: Weeks 1,2,3,4: 0 hour (pre-dose)
Serum Concentrations of LNA043 - Part B
Concentrations for LNA043 were determined by a validated LC-MS/MS method; the anticipated LLOQ was 10ng/mL in serum. Concentrations below the LLOQ were reported as "zero
Measured: Week 1: 0 (pre-dose), 2 hours post dose; Weeks 5 and 13: 1 hour post dose
Serum Concentrations of ANGPTL3 - Part B
Validated bioanalytical assays were used to determine ANGPTL3 in serum with an LLOQ of 2.13 ng/mL. Concentrations below the LLOQ were reported as "zero".
Measured: Week 1: 0 (pre-dose), 2 hours post dose; Weeks 5 and 13: 1 hour post dose
Synovial Fluid Concentrations of LNA043 Part B
Concentrations for LNA043 were determined by a validated LC-MS/MS method; the anticipated LLOQ was 10ng/mL in synovial fluid. Concentrations below the LLOQ were reported as "zero".
Measured: Weeks 1,5.9.13: 0 hour (pre-dose)
Synovial Fluid Concentrations of ANGPTL3 - Part B
Validated bioanalytical assays were used to determine ANGPTL3 in synovial fluid with an LLOQ of 2.74 ng/mL. Concentrations below the LLOQ were reported as "zero".
Measured: Weeks 1,5.9.13: 0 hour (pre-dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 20176 Sep 2022

First posted7 Sep 2017
Study start12 Sep 2017
Primary completion6 Sep 2022
Study completion6 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: A total of 142 participants were randomized, but only 141 received treatment. One participant in Part B was discontinued due to poor veins that were not adequate for blood samples.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03275064
Sponsor's protocol ID: CLNA043X2202
Other IDs: 2016-004052-30, CTI-194705, 2016
Status last verified: Mar 2026
First submitted: 29 Aug 2017
Last updated: 21 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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 trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two-part, Randomized, Placebo-controlled, Patient and Investigator Blinded, Study Investigating the Safety, Tolerability and Preliminary Efficacy of Intra-articular LNA043 Injections in Regenerating the Articular Cartilage of the Knee in Patients With Articular Cartilage Lesions (Part A) and in Patients With Knee Osteoarthritis (Part B).
ClinicalTrials.gov ID: NCT03275064
Acronym / sponsor ID: CLNA043X2202
Conditions: Osteoarthritis
Keywords: Articular cartilage, partial thickness cartilage lesion, knee cartilage, regeneration, osteoarthritis, adult
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 12 Sep 2017 (actual)
Primary completion: 6 Sep 2022 (actual)
Study completion: 6 Sep 2022 (actual)
First posted: 7 Sep 2017 (actual)
Results: Posted 14 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

In Part B, this study aimed at further evaluating the cartilage anabolic activity of LNA043 in a more severe knee OA population, and to explore the safety and efficacy of a higher dose.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5
Model description: A total of 142 participants were randomized, but only 141 received treatment. One participant in Part B was discontinued due to poor veins that were not adequate for blood samples.

Arm	Type	Receives
LNA043 40 mg Part B	Experimental	Biological: LNA043LNA043 40 mg Part B
LNA043 20 mg Part B	Experimental	Biological: LNA043LNA043 20 mg Part B
LNA043 20 mg Part A	Experimental	Biological: LNA043LNA043 20 mg Part A
Placebo Part A	Placebo comparator	Other: PlaceboPlacebo Part A
Placebo Part B	Placebo comparator	Other: PlaceboPlacebo Part B

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Patient was ≥18 and ≤55 years old at time of screening.
Patient had a body mass index (BMI) <30 kg/m2 at screening,
Patient had a symptomatic, single, articular cartilage defect of one knee, grade II or IIIA according to the ICRS classification, localized to either the femoral condyles/femoral trochlea or to the patella, based on MRI or arthroscopy performed within 9 months before screening visit and confirmed by screening 3T MRI.
Patient had an onset of pain and impairment of function between two (2) months and two (2) years before screening.
Patient had a grade 2 or 3 OA of the knee with Joint Space Width (JSW) 2-4 mm evaluated with X-Ray at screening

Key exclusion criteria (15 listed)

Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 15 days after stopping of investigational drug.
Patient had surgical treatment of the target knee using mosaicplasty, microfracture, meniscectomy >50% (Note: prior diagnostic arthroscopy with debridement and lavage, <50% meniscectomy, lateral release, patellar realignment, medial patellofemoral ligament reconstruction are acceptable if performed at least 2 months prior to screening; anteriorcruciate ligament reconstrucion is acceptable if performed 12 months prior to screening, or less if restoration of joint function is evident, and agreed by the sponsor).
Patient had an unstable target knee joint or insufficiently reconstructed ligaments based on medical history and physical examination by the investigator.
Prohibited medication updated with reference to dosing (formerly screening).
Regular smokers (> 5 cigarettes/day). Urine cotinine levels will be measured during screening for all patients. Regular smokers will be defined as any patient who reports tobacco use of > 5 cigarettes/day and/or who has a urine cotinine ≥ 500 ng/mL.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LNA043LNA043 intra-articular injection	Biological	LNA043 20 mg Part A, LNA043 20 mg Part B, LNA043 40 mg Part B
PlaceboPlacebo intra-articular injection	Other	Placebo Part A, Placebo Part B

Primary outcome

Change From Baseline in Articular Cartilage Collagen Organization in the Overall Cartilage (Femoral and Patellar Lesions) - Part A
Time frame: Baseline up to Week 16, Week 28
Collagen fibril organization in articular cartilage evaluated by Magnetic Resonance Imaging (MRI) from the cartilage mean T2 relaxation time (with lower values indicative of higher quality). The area of interest is the focal cartilage lesion.
Change From Baseline in Articular Cartilage Collagen Organization in the Deep Cartilage Layer (Femoral and Patellar Lesions) - Part A
Time frame: Baseline up to Week 16, Week 28
Collagen fibril organization in articular cartilage evaluated by MRI from the cartilage mean T2 relaxation time (with lower values indicative of higher quality). The area of interest is the focal cartilage lesion.
Change From Baseline in Articular Cartilage Collagen Organization in the Superficial Cartilage Layer (Femoral and Patellar Lesions) - Part A
Time frame: Baseline up to Week 16, Week 28
Collagen fibril organization in articular cartilage evaluated by MRI from the cartilage mean T2 relaxation time (with lower values indicative of higher quality).The area of interest is the focal cartilage lesion.
Change From Baseline of LNA043 to Placebo in Cartilage Volume in the Femoral Medial Index Region (mm3) - Part B
Time frame: Baseline, Week 29, Week 53
MRI based quantitative assessment using an automated segmentation algorithm
Change From Baseline of LNA043 to Placebo in Cartilage Thickness in the Femoral Medial Index Region (mm) - Part B
Time frame: Baseline, Week 29, Week 53
MRI based quantitative assessment using an automated segmentation algorithm.
Overview of Number of Participants With Adverse Events and Serious Adverse Events for Part A and Part B
Time frame: Baseline up to end of post treatment follow-up
Treatment emergent other and serious adverse events (TEAE and TESAE) period: Part A: Baseline up to Day 50 (included 30 day safety follow-up Part B: Baseline up to Day 113 (included 30 day safety follow-up) Long term Follow-UP period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365

14 secondary outcomes

Change From Baseline of LNA043 to Placebo in Cartilage Defect Volume (mm^3) for Both Groups of Patients (Femoral and Patellar Lesions) - Part A
Time frame: Baseline up to Week 16, Week 28
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Overall Part B
Time frame: Baseline, Week 29, Week 53
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Deep Part B
Time frame: Baseline, Week 29, Week 53
Change From Baseline in Cartilage Mean T2 Relaxation Time as a Marker of Collagen Organization in the Medial Femoral Index Region - Superficial Part B
Time frame: Baseline, Week 29, Week 53
Incidence of Immunogenicity (IG) Part A
Time frame: Week 1,3,8,16,28
Incidence of Immunogenicity (IG) Part B
Time frame: Week 1,5,9,13,17,29,53
Serum Concentrations of LNA043 - Part A
Time frame: Week 1: 0 (pre-dose), 0.25 hours, 1, 2 hours post dose; Weeks 2, 3, 4: 0 hour (pre dose), 1 hour post dose
Serum Concentrations of ANGPTL3 - Part A
Time frame: Week 1: 0 (pre-dose), 0.25 hours, 1, 2 hours post dose; Weeks 2, 3, 4: 0 hour (pre dose), 1 hour post dose
Synovial Fluid Concentrations of LNA043 - Part A
Time frame: Weeks 1,2,3,4: 0 hour (pre-dose)
Synovial Fluid Concentrations of ANGPTL3 - Part A
Time frame: Weeks 1,2,3,4: 0 hour (pre-dose)
Serum Concentrations of LNA043 - Part B
Time frame: Week 1: 0 (pre-dose), 2 hours post dose; Weeks 5 and 13: 1 hour post dose
Serum Concentrations of ANGPTL3 - Part B
Time frame: Week 1: 0 (pre-dose), 2 hours post dose; Weeks 5 and 13: 1 hour post dose
Synovial Fluid Concentrations of LNA043 Part B
Time frame: Weeks 1,5.9.13: 0 hour (pre-dose)
Synovial Fluid Concentrations of ANGPTL3 - Part B
Time frame: Weeks 1,5.9.13: 0 hour (pre-dose)

Results and safety

Results posted to the registry on 14 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LNA043 20 mg Part A	43	43
Placebo Part A	15	15
LNA043 20 mg Part B	27	27
LNA043 40 mg Part B	27	26
Placebo Part B	29	29

Primary outcome: Change From Baseline in Articular Cartilage Collagen Organization in the Overall Cartilage (Femoral and Patellar Lesions) - Part A

Time frame: Baseline up to Week 16, Week 28. Mean (Standard Error). Unit: ms

Measure	LNA043 20 mg Part A n = 41	Placebo Part A n = 15
Week 16	3.02 (9.66)	2.86 (16.31)
Week 28	5.59 (9.86)	2.05 (15.91)

LNA043 20 mg Part A vs Placebo Part A: Mean Difference (Net): 0.48 (90% CI -30.73 to 31.69), Mixed Models Analysis
LNA043 20 mg Part A vs Placebo Part A: Mean Difference (Net): 3.68 (90% CI -27.04 to 34.40), Mixed Models Analysis

Population analysed: Pharmacodynamic (PD) analysis set: Subjects with available PD data

Primary outcome: Change From Baseline in Articular Cartilage Collagen Organization in the Deep Cartilage Layer (Femoral and Patellar Lesions) - Part A

Time frame: Baseline up to Week 16, Week 28. Mean (Standard Error). Unit: ms

Measure	LNA043 20 mg Part A n = 17	Placebo Part A n = 9
Week 16	-0.2 (8.18)	-2.20 (12.78)
Week 28	4.27 (8.68)	-3.17 (11.46)

LNA043 20 mg Part A vs Placebo Part A: Mean Difference (Final Values): 1.69 (90% CI -27.70 to 31.08), Mixed Models Analysis
LNA043 20 mg Part A vs Placebo Part A: Mean Difference (Net): 5.97 (90% CI -23.03 to 34.97), Mixed Models Analysis

Population analysed: Pharmacodynamic (PD) analysis set: Subjects with available PD data

Primary outcome: Change From Baseline in Articular Cartilage Collagen Organization in the Superficial Cartilage Layer (Femoral and Patellar Lesions) - Part A

Time frame: Baseline up to Week 16, Week 28. Mean (Standard Error). Unit: ms

Measure	LNA043 20 mg Part A n = 17	Placebo Part A n = 9
Week 16 n=17,7	-13.05 (15.68)	-13.93 (24.73)
Week 28 n=16,9	-10.45 (16.61)	-12.73 (22.09)

LNA043 20 mg Part A vs Placebo Part A: Mean Difference (Net): 0.88 (90% CI -47.27 to 49.04), Mixed Models Analysis
LNA043 20 mg Part A vs Placebo Part A: Mean Difference (Net): 2.27 (90% CI -43.11 to 47.65), Mixed Models Analysis

Population analysed: Pharmacodynamic (PD) analysis set: Subjects with available PD data

Primary outcome: Change From Baseline of LNA043 to Placebo in Cartilage Volume in the Femoral Medial Index Region (mm3) - Part B

Time frame: Baseline, Week 29, Week 53. Mean (Standard Error). Unit: mm^3

Measure	LNA043 20 mg Part B n = 12	LNA043 40 mg Part B n = 13	Placebo Part B n = 13
Week 29 n=12,13,13	45.52 (61.90)	-12.79 (60.38)	-154.7 (60.25)
Week 53 n=11,13,7	75.54 (54.48)	-36.52 (51.21)	-152.7 (67.72)

LNA043 20 mg Part B vs Placebo Part B: Mean Difference (Net): 200.18 (90% CI 54.53 to 345.83), p = 0.0131, Mixed Models Analysis
LNA043 40 mg Part B vs Placebo Part B: Mean Difference (Net): 141.87 (90% CI -3.83 to 287.56), p = 0.0544, Mixed Models Analysis
LNA043 20 mg Part B vs Placebo Part B: Mean Difference (Net): 228.27 (90% CI 80.87 to 375.67), p = 0.0067, Mixed Models Analysis

Population analysed: Pharmacodynamic (PD) analysis set: participants with baseline and at least one follow-up MRI assessments for volume of sufficient quality

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment emergent (TE) averse events: Part A: Baseline up to Day 50 (including 30 day safety follow-up post last dose) Part B: Baseline up to Day 113 (including 30 day safety follow-up post last dose) Long term Follow-Up (FU) period: Part A: Day 51 to Day 365 Part B: Day 114 to Day 365. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LNA043 20 mg Part A - TE	0 of 43 (0%)	19 of 43 (44.2%)	0 of 43
Placebo Part A - TE	0 of 15 (0%)	7 of 15 (46.7%)	0 of 15
LNA043 20 mg Part B - TE	1 of 27 (3.7%)	6 of 27 (22.2%)	0 of 27
LNA043 40 mg Part B - TE	0 of 27 (0%)	15 of 27 (55.6%)	0 of 27
Placebo Part B - TE	0 of 29 (0%)	10 of 29 (34.5%)	0 of 29
LNA043 20 mg Part A - FU	2 of 43 (4.7%)	16 of 43 (37.2%)	0 of 43
Placebo Part A - FU	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15
LNA043 20 mg Part B - FU	1 of 27 (3.7%)	3 of 27 (11.1%)	0 of 27
LNA043 40 mg Part B - FU	0 of 27 (0%)	5 of 27 (18.5%)	0 of 27
Placebo Part B - FU	2 of 29 (6.9%)	12 of 29 (41.4%)	0 of 29

Limitations and caveats (from the sponsor): For several outcomes there was a loss in samples size, which may limit the interpretability of results. For Part B, subgroup 1 was defined to address heterogeneity in MRI quality, and to ensure validity of the reported data. P-values for T2 relaxation time are omitted, as there was an error in the calculation. For Part A, the protocol sample size section refers to a ratio for the primary analysis, but data was reported as superficial and deep cartilage layers separately. Both will be updated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Plain Language Trial Summary is available on novctrd.comLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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 trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

19 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LNA043 in people with Osteoarthritis, run by Novartis Pharmaceuticals at 19 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Czechia, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Articular Cartilage Collagen Organization in the Overall Cartilage (Femoral and Patellar Lesions) - Part A (time frame: Baseline up to Week 16, Week 28). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03275064.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.