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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04864392




Registration number
NCT04864392
Ethics application status
Date submitted
26/02/2021
Date registered
28/04/2021

Titles & IDs
Public title
Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis
Scientific 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
Secondary ID [1] 0 0
2020-004897-22
Secondary ID [2] 0 0
CLNA043A12202
Universal Trial Number (UTN)
Trial acronym
ONWARDS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LNA043 Dosing Regimen A
Treatment: Drugs - LNA043 Dosing Regimen B
Treatment: Drugs - LNA043 Dosing Regimen C
Treatment: Drugs - LNA043 Dosing Regimen D
Treatment: Drugs - Placebo

Experimental: LNA043 Dosing Regimen A - LNA043 injection to the knee with dosing regimen A

Experimental: LNA043 Dosing Regimen B - LNA04 injection to the knee with dosing regimen B

Experimental: LNA043 Dosing Regimen C - LNA043 injection to the knee with dosing regimen C

Experimental: LNA043 Dosing Regimen D - LNA043 injection to the knee with dosing regimen D

Placebo comparator: Placebo - Injection to the knee


Treatment: Drugs: LNA043 Dosing Regimen A
Injection to the knee

Treatment: Drugs: LNA043 Dosing Regimen B
Injection to the knee

Treatment: Drugs: LNA043 Dosing Regimen C
Injection to the knee

Treatment: Drugs: LNA043 Dosing Regimen D
Injection to the knee

Treatment: Drugs: Placebo
Injection to the knee
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging.
Timepoint [1] 0 0
Week 0 to Week 104
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Week 0 to Week 104
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Week 0 to Week 104
Secondary outcome [3] 0 0
Change from baseline in the cartilage thickness of the knee as assessed by imaging.
Timepoint [3] 0 0
Week 0 to Week 104
Secondary outcome [4] 0 0
Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 40-meter (4×10m) fast-paced walk test
Timepoint [4] 0 0
Week 0 to Week 104
Secondary outcome [5] 0 0
Change from baseline in the Osteoarthritis Research Society International physical performance-based assessments 30-second chair stand test
Timepoint [5] 0 0
Week 0 to Week 104
Secondary outcome [6] 0 0
Change from baseline in the Osteoarthritis Research Society International physical performance-based assessment of 6-minute walking test
Timepoint [6] 0 0
Weeek 0 to Week 104
Secondary outcome [7] 0 0
Proportion of participants demonstrating structural progression
Timepoint [7] 0 0
Week 0 to Week 104
Secondary outcome [8] 0 0
Assessing percentage of participants with adverse events and serious adverse events
Timepoint [8] 0 0
Week 0 to Week 104

Eligibility
Key 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
Minimum age
40 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
31/05/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/10/2027
Actual
Sample size
Target
Accrual to date
Final
581
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Broadmeadow
Recruitment hospital [2] 0 0
Novartis Investigative Site - St Leonards
Recruitment hospital [3] 0 0
Novartis Investigative Site - Maroochydore
Recruitment hospital [4] 0 0
Novartis Investigative Site - Woodville
Recruitment hospital [5] 0 0
Novartis Investigative Site - Hobart
Recruitment hospital [6] 0 0
Novartis Investigative Site - Malvern East
Recruitment hospital [7] 0 0
Novartis Investigative Site - Christchurch
Recruitment hospital [8] 0 0
Novartis Investigative Site - Paraparaumu
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2065 - St Leonards
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
3145 - Malvern East
Recruitment postcode(s) [7] 0 0
8011 - Christchurch
Recruitment postcode(s) [8] 0 0
5032 - Paraparaumu
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
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United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
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Louisiana
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United States of America
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Maryland
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United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
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New York
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United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Virginia
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Argentina
State/province [13] 0 0
Ciudad Autonoma de Bs As
Country [14] 0 0
Argentina
State/province [14] 0 0
Cordoba
Country [15] 0 0
Argentina
State/province [15] 0 0
Tucuman
Country [16] 0 0
Canada
State/province [16] 0 0
Quebec
Country [17] 0 0
China
State/province [17] 0 0
Beijing
Country [18] 0 0
China
State/province [18] 0 0
Bengbu
Country [19] 0 0
Czechia
State/province [19] 0 0
Czech Republic
Country [20] 0 0
Czechia
State/province [20] 0 0
CZE
Country [21] 0 0
Czechia
State/province [21] 0 0
Brno
Country [22] 0 0
Czechia
State/province [22] 0 0
Praha 2
Country [23] 0 0
Czechia
State/province [23] 0 0
Uherske Hradiste
Country [24] 0 0
Denmark
State/province [24] 0 0
Aarhus N
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Denmark
State/province [25] 0 0
Gandrup
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Denmark
State/province [26] 0 0
Vejle
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Estonia
State/province [27] 0 0
Tallinn
Country [28] 0 0
Estonia
State/province [28] 0 0
Tartu
Country [29] 0 0
India
State/province [29] 0 0
Gujarat
Country [30] 0 0
India
State/province [30] 0 0
Uttar Pradesh
Country [31] 0 0
India
State/province [31] 0 0
Belgavi
Country [32] 0 0
India
State/province [32] 0 0
Pune
Country [33] 0 0
Japan
State/province [33] 0 0
Tokyo
Country [34] 0 0
Japan
State/province [34] 0 0
Chuoh-ku
Country [35] 0 0
Japan
State/province [35] 0 0
Osaka
Country [36] 0 0
Mexico
State/province [36] 0 0
Jalisco
Country [37] 0 0
Mexico
State/province [37] 0 0
Sinaloa
Country [38] 0 0
Mexico
State/province [38] 0 0
Ciudad De
Country [39] 0 0
Poland
State/province [39] 0 0
Kielce
Country [40] 0 0
Poland
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Krakow
Country [41] 0 0
Poland
State/province [41] 0 0
Poznan
Country [42] 0 0
Poland
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Warszawa
Country [43] 0 0
Spain
State/province [43] 0 0
A Coruna
Country [44] 0 0
Spain
State/province [44] 0 0
Barcelona
Country [45] 0 0
Spain
State/province [45] 0 0
Catalunya
Country [46] 0 0
Spain
State/province [46] 0 0
Galicia
Country [47] 0 0
Spain
State/province [47] 0 0
Madrid
Country [48] 0 0
Spain
State/province [48] 0 0
Sevilla
Country [49] 0 0
Taiwan
State/province [49] 0 0
Changhua
Country [50] 0 0
Taiwan
State/province [50] 0 0
Tainan
Country [51] 0 0
United Kingdom
State/province [51] 0 0
Barnet
Country [52] 0 0
United Kingdom
State/province [52] 0 0
Glasgow
Country [53] 0 0
United Kingdom
State/province [53] 0 0
Norwich

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04864392