Study on the Effects of LNA043 for Patients with Knee Osteoarthritis

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What is this study about?

This clinical trial is focused on studying knee osteoarthritis, a common joint condition that causes pain and stiffness in the knees. The study will evaluate a treatment called LNA043, which is a powder that is mixed into a solution and injected directly into the knee joint. The purpose of the study is to assess how effective, safe, and tolerable this treatment is compared to a placebo in patients who have symptoms of knee osteoarthritis.

Participants in the study will receive either the LNA043 treatment or a placebo through injections into the knee. The study will last for up to five years, during which time the effects of the treatment on knee structure and function will be monitored. The main focus will be on changes in the knee’s structure, particularly in the central part of the knee joint, over a period of two years. Additionally, the study will look at changes in pain levels, physical function, and cartilage structure, as well as any side effects that may occur.

The study aims to provide valuable information on whether LNA043 can help improve the condition of the knee joint in people with osteoarthritis, potentially offering a new treatment option for managing this painful condition. Participants will be closely monitored throughout the study to ensure their safety and to gather comprehensive data on the treatment’s effects.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, body mass index, and diagnosis of knee osteoarthritis.

The assessment ensures that the condition is primarily affecting the knee and that pain levels meet the study’s criteria.

2 baseline measurements

Baseline measurements are taken to evaluate the current condition of the knee. This includes imaging to assess the knee structure and measuring pain levels using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).

3 treatment administration

Participants receive the study medication, LNA043, or a placebo. The medication is administered as a powder for solution for injection directly into the knee joint (intraarticular use).

The frequency and dosage of the injections are determined by the study protocol and are administered over a specified period.

4 follow-up assessments

Regular follow-up assessments are conducted to monitor changes in knee structure and pain levels. These assessments occur at various intervals throughout the study period.

Participants are evaluated for any adverse events or changes in their condition.

5 final evaluation

At the end of the study period, a final evaluation is conducted to assess the overall effectiveness of the treatment.

This includes a comprehensive review of changes in knee structure, pain levels, and physical function.

Who Can Join the Study?

Men and women who are between 40 and 75 years old.
Have a Body Mass Index (BMI) of less than 40 kg/m². BMI is a measure that uses your height and weight to work out if your weight is healthy.
Have been diagnosed with primary tibiofemoral knee osteoarthritis (OA) using standard clinical and X-ray criteria. Osteoarthritis is a condition that affects the joints, causing pain and stiffness.
Have knee osteoarthritis with a specific X-ray grade (K-L grade 2 or 3) and mainly affecting the inner part of the knee joint, shown by a narrowing of the joint space.
Experience a certain level of pain in the knee, measured by a score of 20-45 out of 50 on the WOMAC pain scale, during two assessments after stopping pain medications for a specific period.
Have had pain in the knee for at least 6 months.
The main source of pain in the body should be due to osteoarthritis in the knee, with a specific score on the Widespread Pain Index and Symptom Severity scale.

Who Cannot Join the Study?

Patients who have any other joint diseases besides osteoarthritis cannot participate. Osteoarthritis is a condition where the protective cartilage that cushions the ends of the bones wears down over time.
Patients who have had surgery on the knee that is being studied are not eligible.
Patients who have received certain treatments for osteoarthritis in the past 6 months cannot join the study.
Patients with a history of cancer in the past 5 years, except for some skin cancers, are excluded.
Patients who have any serious medical conditions that could affect their safety or the study results are not allowed to participate.
Patients who are pregnant or breastfeeding cannot take part in the study.
Patients who are participating in another clinical trial at the same time are not eligible.
Patients who have allergies to any of the study medications or their ingredients cannot join the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Krakowskie Centrum Medyczne Sp. z o.o.	Cracow	Poland
Reumedika s.c.	Poznan	Poland

Other Sites

Site Name	City	Country
Revmatologicky Ustav	Prague	Czechia
Sanos A/S	Gandrup	Denmark
Hospital Del Mar	Barcelona	Spain
Pzu Zdrowie S.A.	Kielce	Poland
Revmacentrum MUDr. Mostera s.r.o.	Brno-Zidenice	Czechia
Medical Plus s.r.o.	Uherske Hradiste	Czechia
Hospital Hm Rosaleda Hm La Esperanza	Santiago De Compostela	Spain
Etg Neuroscience Sp. z o.o.	Warsaw	Poland
Pratia Pardubice a.s.	Pardubice	Czechia
MediTrials OÜ	Tartu	Estonia
Pratia Brno s.r.o.	Brno-Stred	Czechia
Center for Clinical and Basic Research AS	Tallin	Estonia
Rrrvegzokkux ssqzfi	Brno-Sever	Czechia
Mhdzkdzux Ikxykkuaiw Ccfthpoq Srxdvazd Sal z opye	Warsaw	Poland
Pbag Thvfm Hssoysas Ufpvpsayagkf	Sabadell	Spain
Avmtzb Ulsgkjzmjb Hxgdfwta	Aarhus	Denmark
Fxuokoloy Pgrx Lm Iaktozijaaduj Bikaquyuq Dvp Hspzdsjy Uxsdeyvskucxr Lx Ptz	Madrid	Spain
Hjgaqngu Uyzezdogznjyc dl A Clmcxo	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	21.07.2021
Denmark	Not recruiting	21.07.2021
Estonia	Not recruiting	21.07.2021
Poland	Not recruiting	21.07.2021
Spain	Not recruiting	21.07.2021

Trial locations

Investigated drugs:

Lna043

LNA043 is a medication being studied for its potential to improve knee structure in patients with symptomatic knee osteoarthritis. The trial aims to assess how this medication affects the knee joint over a period of time, specifically looking at changes in the central part of the knee. The goal is to determine if LNA043 can provide relief and improve the condition of the knee compared to not receiving the active treatment.

Osteoarthritis – Osteoarthritis is a common joint disorder that primarily affects the cartilage, which is the protective tissue at the ends of bones. Over time, the cartilage wears down, leading to pain, swelling, and reduced motion in the affected joints. It most commonly occurs in the knees, hips, and hands. As the disease progresses, the bones may begin to rub against each other, causing further pain and joint damage. This can lead to the development of bone spurs and a decrease in joint function. The progression of osteoarthritis can vary, with some individuals experiencing rapid changes while others have a slower progression.

Trial ID:

2023-509937-37-00

Protocol code:

CLNA043A12202

NCT ID:

NCT04864392

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of LNA043 for Patients with Knee Osteoarthritis

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