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Antisense Oligonucleotide

LNA043 for Knee Osteoarthritis (ONWARDS Trial)

Phase 2
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 0 to week 104
Awards & highlights

ONWARDS Trial Summary

This trial will help find the best dose of the drug LNA043 for people with knee osteoarthritis.

Eligible Conditions
  • Osteoarthritis

ONWARDS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 0 to week 104
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 to week 104 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in the cartilage thickness of the medial compartment of the knee as assessed by imaging.
Secondary outcome measures
Assessing percentage of participants with adverse events and serious adverse events
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.
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.
+5 more

ONWARDS Trial Design

5Treatment groups
Experimental Treatment
Placebo Group
Group I: LNA043 Dosing Regimen DExperimental Treatment1 Intervention
LNA043 injection to the knee with dosing regimen D
Group II: LNA043 Dosing Regimen CExperimental Treatment1 Intervention
LNA043 injection to the knee with dosing regimen C
Group III: LNA043 Dosing Regimen BExperimental Treatment1 Intervention
LNA04 injection to the knee with dosing regimen B
Group IV: LNA043 Dosing Regimen AExperimental Treatment1 Intervention
LNA043 injection to the knee with dosing regimen A
Group V: PlaceboPlacebo Group1 Intervention
Injection to the knee

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,196,806 Total Patients Enrolled
12 Trials studying Osteoarthritis
2,107 Patients Enrolled for Osteoarthritis

Media Library

LNA043 (Antisense Oligonucleotide) Clinical Trial Eligibility Overview. Trial Name: NCT04864392 — Phase 2
Osteoarthritis Research Study Groups: Placebo, LNA043 Dosing Regimen A, LNA043 Dosing Regimen B, LNA043 Dosing Regimen C, LNA043 Dosing Regimen D
Osteoarthritis Clinical Trial 2023: LNA043 Highlights & Side Effects. Trial Name: NCT04864392 — Phase 2
LNA043 (Antisense Oligonucleotide) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04864392 — Phase 2
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04864392 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA officially sanctioned LNA043 Dosing Regimen A?

"With limited data supporting efficacy, but some evidence that LNA043 Dosing Regimen A is safe, it was given a rating of 2."

Answered by AI

Is participation in this clinical research open to the public?

"This trial is looking for 550 individuals with arthrosis between the ages of 40 and 75. To be eligible they must fulfill certain prerequisites, including: Being a male or female aged 40 to 75 years old; having a BMI lower than 40 kg/m2; being diagnosed with primary tibiofemoral knee OA according to all American College of Rheumatology clinical and radiographic criteria; as well as any other conditions specified by the protocol."

Answered by AI

Are there any remaining opportunities for participants in this experiment?

"Affirmative. According to the clinicaltrials.gov records, recruitment for this medical trial is currently underway and began on May 31st 2021 with a most recent update posted on November 4th 2022. The study aims to enrol 550 participants at two different sites."

Answered by AI

What is the total participant count for this research endeavor?

"Verified, the information contained on clinicaltrials.gov shows this medical trial is still in progress and new participants are being recruited since its initial posting date of May 31st 2021. The study requires 550 patients from 2 separate locations to finish successfully."

Answered by AI

Does the trial include individuals above seventy-five years of age?

"Eligible patients for this clinical trial must fall within the age bracket of 40 to 75. Moreover, there are 38 trials that cater specifically to minors and 656 studies dedicated exclusively towards senior citizens."

Answered by AI

Who else is applying?

What state do they live in?
California
Other
Texas
Arizona
How old are they?
18 - 65
65+
What site did they apply to?
Novartis Investigative Site
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0

Why did patients apply to this trial?

I want to maintain/ improve my active lifestyle. I struggle with knee osteoarthritis and wish to do anything that might keep me from having the knee replaced.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Novartis Investigative Site: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis
2021. "Study of Efficacy, Safety, and Tolerability of LNA043 in Patients With Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04864392.
~73 spots leftby Oct 2024
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