Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis
A 5-year, Randomized, Double-blind, Placebo-controlled, Multi-center Study Assessing the Efficacy, Safety, and Tolerability of Intra-articular Regimens of LNA043 Versus Placebo in Patients With Symptomatic Knee Osteoarthritis
ClinicalTrials.gov Identifier: NCT04864392
Novartis Reference Number: CLNA043A12202
Last Update: Feb 01, 2022
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 study will determine the optimal dosing regimen of LNA043 in patients with knee osteoarthritis (OA).
Condition
Osteoarthritis
Phase
Phase 2
Overall status
Recruiting
Start date
May 31, 2021
Completion date
Oct 25, 2027
Gender
All
Age(s)
40 Years - 75 Years (Adult, Older Adult)
Interventions
Drug
LNA043 Dosing Regimen A
Injection to the knee
Drug
LNA043 Dosing Regimen B
Injection to the knee
Drug
LNA043 Dosing Regimen C
Injection to the knee
Drug
LNA043 Dosing Regimen D
Injection to the knee
Drug
Placebo
Injection to the knee
Eligibility Criteria
Inclusion Criteria:
Males and females between 40 and 75 years of age
Body mass index (BMI) < 40 kg/m2
Diagnosis of primary tibiofemoral knee OA by standard American College of Rheumatology clinical and radiographic criteria
and other criteria as specified by the protocol
Exclusion Criteria:
Participants with radiographic knee OA K-L grade = 4 on the non-target knee
Arthroscopy of the target knee within the 6 months prior to Screening
Hemoglobin < 8.5 g/dL (85 g/L) or platelet count < 100,000/μL
and other criteria as specified by the protocol
Study Locations
United States
Novartis Investigative Site
Recruiting
Phoenix, 85018
Arizona
United States
Novartis Investigative Site
Recruiting
Tucson, 85712
Arizona
United States
Novartis Investigative Site
Recruiting
La Mesa, 91942
California
United States
Novartis Investigative Site
Recruiting
Lincoln, 95648
California
United States
Novartis Investigative Site
Recruiting
Long Beach, 90806
California
United States
Novartis Investigative Site
Recruiting
Riverside, 92503
California
United States
Novartis Investigative Site
Recruiting
San Diego, 92103
California
United States
Novartis Investigative Site
Recruiting
Stamford, 06905
Connecticut
United States
Novartis Investigative Site
Recruiting
Maitland, 32751
Florida
United States
Novartis Investigative Site
Recruiting
Ocoee, 34761
Florida
United States
Novartis Investigative Site
Recruiting
Winter Park, 32789
Florida
United States
Novartis Investigative Site
Recruiting
Chicago, 60607
Illinois
United States
Novartis Investigative Site
Recruiting
Marrero, 70072
Louisiana
United States
Novartis Investigative Site
Recruiting
Wheaton, 20902
Maryland
United States
Novartis Investigative Site
Recruiting
Kansas City, 64114
Missouri
United States
Novartis Investigative Site
Recruiting
Hartsdale, 10530
New York
United States
Novartis Investigative Site
Recruiting
Knoxville, 37920
Tennessee
United States
Novartis Investigative Site
Recruiting
Dallas, 75231
Texas
United States
Novartis Investigative Site
Recruiting
Houston, 77058
Texas
United States
Novartis Investigative Site
Recruiting
Sugar Land, 77479
Texas
United States
Novartis Investigative Site
Recruiting
Charlottesville, 22911
Virginia
United States
Australia
Novartis Investigative Site
Recruiting
Botany, 2019
New South Wales
Australia
Novartis Investigative Site
Recruiting
Broadmeadow, 2292
New South Wales
Australia
Novartis Investigative Site
Recruiting
St Leonards, 2065
New South Wales
Australia
Novartis Investigative Site
Recruiting
Maroochydore, 4558
Queensland
Australia
Novartis Investigative Site
Recruiting
Hobart, 7000
Tasmania
Australia
Novartis Investigative Site
Recruiting
Malvern East, 3145
Victoria
Australia
China
Novartis Investigative Site
Recruiting
Beijing, 100044
Beijing
China
Novartis Investigative Site
Recruiting
Guiyang, 550004
Guizhou
China
Novartis Investigative Site
Recruiting
Bengbu, 233004
-
China
Czech Republic
Novartis Investigative Site
Recruiting
Brno, 66250
Czech Republic
Czech Republic
Novartis Investigative Site
Recruiting
Brno, 63800
-
Czech Republic
Novartis Investigative Site
Recruiting
Praha 11, 148 00
-
Czech Republic
Novartis Investigative Site
Recruiting
Praha 2, 128 50
-
Czech Republic
Novartis Investigative Site
Recruiting
Uherske Hradiste, 686 01
-
Czech Republic
Denmark
Novartis Investigative Site
Recruiting
Aarhus N, 8200
-
Denmark
Novartis Investigative Site
Recruiting
Hvidovre, 2650
-
Denmark
Novartis Investigative Site
Recruiting
Vejle, 7100
-
Denmark
Estonia
Novartis Investigative Site
Recruiting
Tallinn, 10128
-
Estonia
India
Novartis Investigative Site
Recruiting
Vadodara, 390022
Gujarat
India
Novartis Investigative Site
Recruiting
Bangalore, 560054
Karnataka
India
Japan
Novartis Investigative Site
Recruiting
Shinagawa, 140-0014
Tokyo
Japan
Novartis Investigative Site
Recruiting
Shinjuku ku, 160-0008
Tokyo
Japan
Novartis Investigative Site
Recruiting
Suginami, 166-0003
Tokyo
Japan
Novartis Investigative Site
Recruiting
Chuoh-ku, 104-0031
-
Japan
Novartis Investigative Site
Recruiting
Osaka, 543-0027
-
Japan
Lithuania
Novartis Investigative Site
Recruiting
Vilnius, LT-08406
LTU
Lithuania
Mexico
Novartis Investigative Site
Recruiting
Mexicali, 21100
Baja California
Mexico
Novartis Investigative Site
Recruiting
Merida, 97070
Yucatan
Mexico
Novartis Investigative Site
Recruiting
Ciudad De, CP 06700
-
Mexico
Poland
Novartis Investigative Site
Recruiting
Kielce, 25017
-
Poland
Novartis Investigative Site
Recruiting
Krakow, 31-501
-
Poland
Novartis Investigative Site
Recruiting
Poznan, 60-446
-
Poland
Novartis Investigative Site
Recruiting
Torun, 87-100
-
Poland
Novartis Investigative Site
Recruiting
Warszawa, 02 777
-
Poland
Spain
Novartis Investigative Site
Recruiting
Cordoba, 14004
Andalucia
Spain
Novartis Investigative Site
Recruiting
Sabadell, 08208
Barcelona
Spain
Novartis Investigative Site
Recruiting
Barcelona, 08003
Catalunya
Spain
Novartis Investigative Site
Recruiting
La Coruna, 15006
Galicia
Spain
Novartis Investigative Site
Recruiting
Sevilla, 41010
-
Spain
Novartis Investigative Site
Recruiting
Valencia, 46026
-
Spain
Taiwan
Novartis Investigative Site
Recruiting
Changhua, 50006
-
Taiwan
United Kingdom
Novartis Investigative Site
Recruiting
Barnet, EN5 3DJ
-
United Kingdom
Novartis Investigative Site
Recruiting
Norwich, NR4 7UY
-
United Kingdom
Contacts
Name:
Novartis Pharmaceuticals
Phone:
Have a question?
Call 1-888-669-6682 or email [email protected]