Study of Safety, Tolerability, Preliminary Efficacy of Intra-articular LNA043 Injections in Patients With Articular Cartilage Lesions and Knee Osteoarthritis.
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).
Sponsor: Novartis Pharmaceuticals
This observational or N/A phase trial investigates Osteoarthritis and is currently completed. Novartis Pharmaceuticals leads this study, which shows 23 recorded versions since 2017 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Study Description(click to expand)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...
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.
Status Flow
Change History
23 versions recorded-
Apr 21, 2026 — Present [daily]
Completed
Phase: PHASE2 → None
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Sep 2025 — Apr 2026 [monthly]
Completed PHASE2
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Nov 2024 — Sep 2025 [monthly]
Completed PHASE2
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Sep 2024 — Nov 2024 [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
▶ Show 18 earlier versions
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Mar 2024 — Jul 2024 [monthly]
Completed PHASE2
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Feb 2023 — Mar 2024 [monthly]
Completed PHASE2
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Nov 2022 — Feb 2023 [monthly]
Completed PHASE2
Status: Active Not Recruiting → Completed
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Oct 2021 — Nov 2022 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Sep 2021 — Oct 2021 [monthly]
Recruiting PHASE2
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Feb 2021 — Sep 2021 [monthly]
Recruiting PHASE2
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Jan 2021 — Feb 2021 [monthly]
Recruiting PHASE2
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Oct 2020 — Jan 2021 [monthly]
Recruiting PHASE2
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Aug 2020 — Oct 2020 [monthly]
Recruiting PHASE2
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Jun 2020 — Aug 2020 [monthly]
Recruiting PHASE2
Status: Active Not Recruiting → Recruiting
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Dec 2019 — Jun 2020 [monthly]
Active Not Recruiting PHASE2
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Nov 2019 — Dec 2019 [monthly]
Active Not Recruiting PHASE2
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Oct 2019 — Nov 2019 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Feb 2019 — Oct 2019 [monthly]
Recruiting PHASE2
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Dec 2018 — Feb 2019 [monthly]
Recruiting PHASE2
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Jun 2018 — Dec 2018 [monthly]
Recruiting PHASE2
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Mar 2018 — Jun 2018 [monthly]
Recruiting PHASE2
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Oct 2017 — Mar 2018 [monthly]
Recruiting PHASE2
First recorded
Sep 2017
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility 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).
Contact Information
- Novartis Pharmaceuticals
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Aarhus N, Denmark , Boise, United States , Brno, Czechia , Chicago, United States , Hvidovre, Denmark , Kladno, Czechia , Kolín, Czechia , La Mesa, United States , Las Vegas, United States , Miami Lakes, United States and 9 more locations