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).

ClinicalTrials.gov Identifier: NCT03275064

Novartis Reference Number: CLNA043X2202

See if you pre-qualify

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation. 

Study Description

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).

Condition 
Wounds and Injuries
Phase 
Phase 2
Overall status 
Recruiting
Enrollment count 
60 participants
Start date 
Sep 12, 2017
Completion date 
Apr 15, 2022
Gender 
All
Age(s)
18 Years - 75 Years (Adult, Older Adult)

Interventions

Biological
LNA043
LNA043 intra-articular injection
Other
Placebo
Placebo intra-articular injection

Eligibility Criteria

Inclusion criteria Part A

Patient is ≥18 and ≤55 years old at time of screening.
Patient has a body mass index (BMI) <30 kg/m2 at screening, for patients with BMI >30 but ≤ 33kg/m2, eligibility will be decided by consultation with the sponsor.
Patient has 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 has an onset of pain and impairment of function between two (2) months and two (2) years before screening.
Patient reports a KOOS (sports and recreational activities subscale) score of ≤ 60 at both screening and Day 1.

Inclusion criteria Part B

Patient is ≥18 and ≤75 years old at time of screening.
Patient has a body mass index (BMI) <35 kg/m2 at screening
Diagnosis of femorotibial OA in the target knee by standard American College of Rheumatology (ACR) criteria at study start (clinical AND radiographic criteria)
Patient has a K&L grade 2 or 3 OA of the knee with JSW 2-4 mm evaluated with X-Ray at screening.
Patient must have 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.

Exclusion criteria Part A & B

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 has 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 has an unstable target knee joint or insufficiently reconstructed ligaments based on medical history and physical examination by the investigator.
Patient has patellofemoral dysplasia Dejour Grade B-D based on X-ray evaluation performed within 9 months from screening.
Patient has 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.

Prohibited medication updated with reference to dosing (formerly screening).

Exclusion Criteria Part A only

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 has 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.

Exclusion Criteria Part B only

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

Study Locations

United States
Novartis Investigative Site
Recruiting
Phoenix, 85053
Arizona
United States
Novartis Investigative Site
Withdrawn
Tucson, 85712
Arizona
United States
Novartis Investigative Site
Recruiting
La Mesa, 91942
California
United States
Novartis Investigative Site
Withdrawn
Longwood, 32750
Florida
United States
Novartis Investigative Site
Recruiting
Miami Lakes, 33014
Florida
United States
Novartis Investigative Site
Recruiting
Sunrise, 33351
Florida
United States
Novartis Investigative Site
Recruiting
Tampa, 33603
Florida
United States
Novartis Investigative Site
Completed
Boise, 83702
Idaho
United States
Novartis Investigative Site
Recruiting
Chicago, 60612
Illinois
United States
Novartis Investigative Site
Withdrawn
Greenwood, 46143
Indiana
United States
Novartis Investigative Site
Recruiting
Duncansville, 16635
Pennsylvania
United States
Novartis Investigative Site
Recruiting
Philadelphia, 19140
Pennsylvania
United States
Czechia
Novartis Investigative Site
Recruiting
Brno, 66250
Czech Republic
Czechia
Novartis Investigative Site
Recruiting
Mlada Boleslav, 29301
Czech Republic
Czechia
Novartis Investigative Site
Recruiting
Kladno, 272 59
-
Czechia
Novartis Investigative Site
Recruiting
Kolin, 280 02
-
Czechia
Novartis Investigative Site
Recruiting
Pardubice, 53002
-
Czechia
Novartis Investigative Site
Recruiting
Praha,
-
Czechia
Denmark
Novartis Investigative Site
Completed
Aarhus C, DK 8000
-
Denmark
Novartis Investigative Site
Completed
Hvidovre, 2650
-
Denmark
Sweden
Novartis Investigative Site
Withdrawn
Kungsbacka, 434 80
-
Sweden

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 
1-888-669-6682
Name: 
Novartis Pharmaceuticals
Phone: 
+41613241111
Email: 

Have a question?

Call 1-999-669-6682 or email [email protected]