Back to resultsStudy of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis (ONWARDS)
Primary Purpose
Osteoarthritis
Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
LNA043 Dosing Regimen A
LNA043 Dosing Regimen B
LNA043 Dosing Regimen C
LNA043 Dosing Regimen D
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring LNA043, knee, arthritis, OA, knees
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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
LNA043 Dosing Regimen A
LNA043 Dosing Regimen B
LNA043 Dosing Regimen C
LNA043 Dosing Regimen D
Placebo
Arm Description
LNA043 injection to the knee with dosing regimen A
LNA04 injection to the knee with dosing regimen B
LNA043 injection to the knee with dosing regimen C
LNA043 injection to the knee with dosing regimen D
Injection to the knee
Outcomes
Primary Outcome Measures
Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging.
To evaluate cartilage thickness changes
Secondary Outcome Measures
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index pain scale. The scale (5 questions) ranges from 0 to 50. Higher score indicates a worse outcome.
To evaluate changes from baseline in OA pain
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index function scale. The scale (17 questions) ranges from 0 to 170. Higher scores indicates a worse outcome.
To evaluate changes from baseline in physical function
Change from baseline in the cartilage thickness of the knee as assessed by imaging.
To evaluate changes from baseline the cartilage structure
Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 40-meter (4×10m) fast-paced walk test
To evaluate changes from baseline in physical function
Change from baseline in the Osteoarthritis Research Society International physical performance-based assessments 30-second chair stand test
To evaluate changes from baseline in physical function
Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 6-minute walking test
To evaluate changes from baseline in physical function
Proportion of participants demonstrating structural progression
To evaluate structural progression
Assessing percentage of participants with adverse events and serious adverse events
To evaluate safety and tolerability of the various LNA043 regimens
Full Information
NCT ID
NCT04864392
First Posted
February 26, 2021
Last Updated
September 4, 2023
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT04864392
Brief Title
Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis
Acronym
ONWARDS
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
October 7, 2024 (Anticipated)
Study Completion Date
October 25, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study will determine the optimal dosing regimen of LNA043 in patients with knee osteoarthritis (OA).
Detailed Description
This study is a 2-period, multicenter, randomized, parallel-group, double-blind, placebo-controlled study consisting of a 2-year Core period, followed by a 3 year extension period. The primary objective of this study is to assess the efficacy of LNA043 compared to placebo at Week 104 as measured by the mean change from baseline in cartilage thickness using qMRI of the target knee
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
LNA043, knee, arthritis, OA, knees
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
581 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LNA043 Dosing Regimen A
Arm Type
Experimental
Arm Description
LNA043 injection to the knee with dosing regimen A
Arm Title
LNA043 Dosing Regimen B
Arm Type
Experimental
Arm Description
LNA04 injection to the knee with dosing regimen B
Arm Title
LNA043 Dosing Regimen C
Arm Type
Experimental
Arm Description
LNA043 injection to the knee with dosing regimen C
Arm Title
LNA043 Dosing Regimen D
Arm Type
Experimental
Arm Description
LNA043 injection to the knee with dosing regimen D
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Injection to the knee
Intervention Type
Drug
Intervention Name(s)
LNA043 Dosing Regimen A
Other Intervention Name(s)
LNA043
Intervention Description
Injection to the knee
Intervention Type
Drug
Intervention Name(s)
LNA043 Dosing Regimen B
Other Intervention Name(s)
LNA043
Intervention Description
Injection to the knee
Intervention Type
Drug
Intervention Name(s)
LNA043 Dosing Regimen C
Other Intervention Name(s)
LNA043
Intervention Description
Injection to the knee
Intervention Type
Drug
Intervention Name(s)
LNA043 Dosing Regimen D
Other Intervention Name(s)
LNA043
Intervention Description
Injection to the knee
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Injection to the knee
Primary Outcome Measure Information:
Title
Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging.
Description
To evaluate cartilage thickness changes
Time Frame
Week 0 to Week 104
Secondary Outcome Measure Information:
Title
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index pain scale. The scale (5 questions) ranges from 0 to 50. Higher score indicates a worse outcome.
Description
To evaluate changes from baseline in OA pain
Time Frame
Week 0 to Week 104
Title
Change from baseline in Western Ontario and McMaster Universities Osteoarthritis Index function scale. The scale (17 questions) ranges from 0 to 170. Higher scores indicates a worse outcome.
Description
To evaluate changes from baseline in physical function
Time Frame
Week 0 to Week 104
Title
Change from baseline in the cartilage thickness of the knee as assessed by imaging.
Description
To evaluate changes from baseline the cartilage structure
Time Frame
Week 0 to Week 104
Title
Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 40-meter (4×10m) fast-paced walk test
Description
To evaluate changes from baseline in physical function
Time Frame
Week 0 to Week 104
Title
Change from baseline in the Osteoarthritis Research Society International physical performance-based assessments 30-second chair stand test
Description
To evaluate changes from baseline in physical function
Time Frame
Week 0 to Week 104
Title
Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 6-minute walking test
Description
To evaluate changes from baseline in physical function
Time Frame
Weeek 0 to Week 104
Title
Proportion of participants demonstrating structural progression
Description
To evaluate structural progression
Time Frame
Week 0 to Week 104
Title
Assessing percentage of participants with adverse events and serious adverse events
Description
To evaluate safety and tolerability of the various LNA043 regimens
Time Frame
Week 0 to Week 104
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Novartis Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Novartis Investigative Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Novartis Investigative Site
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Facility Name
Novartis Investigative Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Novartis Investigative Site
City
Riverside
State/Province
California
ZIP/Postal Code
92503
Country
United States
Facility Name
Novartis Investigative Site
City
Sacramento
State/Province
California
ZIP/Postal Code
95821
Country
United States
Facility Name
Novartis Investigative Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Novartis Investigative Site
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Novartis Investigative Site
City
Ocoee
State/Province
Florida
ZIP/Postal Code
34761
Country
United States
Facility Name
Novartis Investigative Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Novartis Investigative Site
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Novartis Investigative Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Novartis Investigative Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
Novartis Investigative Site
City
Wheaton
State/Province
Maryland
ZIP/Postal Code
20902
Country
United States
Facility Name
Novartis Investigative Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
Novartis Investigative Site
City
Hartsdale
State/Province
New York
ZIP/Postal Code
10530
Country
United States
Facility Name
Novartis Investigative Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Novartis Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Novartis Investigative Site
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Novartis Investigative Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Novartis Investigative Site
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Facility Name
Novartis Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23238
Country
United States
Facility Name
Novartis Investigative Site
City
Ciudad Autonoma de Bs As
ZIP/Postal Code
C1428AZF
Country
Argentina
Facility Name
Novartis Investigative Site
City
Cordoba
ZIP/Postal Code
X5000EOC
Country
Argentina
Facility Name
Novartis Investigative Site
City
Tucuman
ZIP/Postal Code
4000
Country
Argentina
Facility Name
Novartis Investigative Site
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Facility Name
Novartis Investigative Site
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Novartis Investigative Site
City
Maroochydore
State/Province
Queensland
ZIP/Postal Code
4558
Country
Australia
Facility Name
Novartis Investigative Site
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Novartis Investigative Site
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Novartis Investigative Site
City
Malvern East
State/Province
Victoria
ZIP/Postal Code
3145
Country
Australia
Facility Name
Novartis Investigative Site
City
Christchurch
ZIP/Postal Code
8011
Country
Australia
Facility Name
Novartis Investigative Site
City
Paraparaumu
ZIP/Postal Code
5032
Country
Australia
Facility Name
Novartis Investigative Site
City
Trois Rivieres
State/Province
Quebec
ZIP/Postal Code
G8Z 1Y2
Country
Canada
Facility Name
Novartis Investigative Site
City
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Facility Name
Novartis Investigative Site
City
Bengbu
ZIP/Postal Code
233004
Country
China
Facility Name
Novartis Investigative Site
City
Brno
State/Province
Czech Republic
ZIP/Postal Code
66250
Country
Czechia
Facility Name
Novartis Investigative Site
City
Pardubice
State/Province
Czech Republic
ZIP/Postal Code
530 02
Country
Czechia
Facility Name
Novartis Investigative Site
City
Brno-Zidonice
State/Province
CZE
ZIP/Postal Code
61500
Country
Czechia
Facility Name
Novartis Investigative Site
City
Brno
ZIP/Postal Code
63800
Country
Czechia
Facility Name
Novartis Investigative Site
City
Praha 2
ZIP/Postal Code
128 50
Country
Czechia
Facility Name
Novartis Investigative Site
City
Uherske Hradiste
ZIP/Postal Code
686 01
Country
Czechia
Facility Name
Novartis Investigative Site
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Novartis Investigative Site
City
Gandrup
ZIP/Postal Code
9362
Country
Denmark
Facility Name
Novartis Investigative Site
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Novartis Investigative Site
City
Tallinn
ZIP/Postal Code
10128
Country
Estonia
Facility Name
Novartis Investigative Site
City
Tartu
ZIP/Postal Code
50406
Country
Estonia
Facility Name
Novartis Investigative Site
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390022
Country
India
Facility Name
Novartis Investigative Site
City
Lucknow
State/Province
Uttar Pradesh
ZIP/Postal Code
226003
Country
India
Facility Name
Novartis Investigative Site
City
Belagavi
ZIP/Postal Code
590010
Country
India
Facility Name
Novartis Investigative Site
City
Pune
ZIP/Postal Code
411019
Country
India
Facility Name
Novartis Investigative Site
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
140-0014
Country
Japan
Facility Name
Novartis Investigative Site
City
Shinjuku ku
State/Province
Tokyo
ZIP/Postal Code
160-0008
Country
Japan
Facility Name
Novartis Investigative Site
City
Suginami
State/Province
Tokyo
ZIP/Postal Code
166-0002
Country
Japan
Facility Name
Novartis Investigative Site
City
Chuoh-ku
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Novartis Investigative Site
City
Osaka
ZIP/Postal Code
543-0027
Country
Japan
Facility Name
Novartis Investigative Site
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44650
Country
Mexico
Facility Name
Novartis Investigative Site
City
Culiacan
State/Province
Sinaloa
ZIP/Postal Code
CP 80000
Country
Mexico
Facility Name
Novartis Investigative Site
City
Ciudad De
ZIP/Postal Code
CP 06700
Country
Mexico
Facility Name
Novartis Investigative Site
City
Kielce
ZIP/Postal Code
25017
Country
Poland
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Novartis Investigative Site
City
Poznan
ZIP/Postal Code
60-446
Country
Poland
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02 777
Country
Poland
Facility Name
Novartis Investigative Site
City
Santiago de Compostela
State/Province
A Coruna
ZIP/Postal Code
15705
Country
Spain
Facility Name
Novartis Investigative Site
City
Sabadell
State/Province
Barcelona
ZIP/Postal Code
08208
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
State/Province
Catalunya
ZIP/Postal Code
08003
Country
Spain
Facility Name
Novartis Investigative Site
City
La Coruna
State/Province
Galicia
ZIP/Postal Code
15006
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Novartis Investigative Site
City
Sevilla
ZIP/Postal Code
41010
Country
Spain
Facility Name
Novartis Investigative Site
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Tainan
ZIP/Postal Code
70403
Country
Taiwan
Facility Name
Novartis Investigative Site
City
Barnet
ZIP/Postal Code
EN5 3DJ
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Norwich
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
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
Learn more about this trial
Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis
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